Trial Outcomes & Findings for Treatment Study of Steroid Injection and Physical Therapy for Acute Lateral Epicondylitis (NCT NCT00826462)

NCT ID: NCT00826462

Last Updated: 2022-01-24

Results Overview

Unadjusted event rates of treatment success, defined as participants rating themselves 'much improved' or 'completely recovered' on a six point scale. Percentage with 99% confidence interval.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 177 participants
• Primary outcome timeframe: 6 - 52 weeks
• Results posted on: 2022-01-24

Participant Flow

Participant milestones

Measure	Corticosteroid Injection in Combination With Physical Therapy Corticosteroid injection in combination with physical therapy Injection with triamcinolone 10 mg and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn Entero 500 mg bid for 14 days triamcinolone: Injection with triamcinolone 10 mg at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days	Placebo Injection in Combination With Physical Therapy Placebo injection in combination with physical therapy Injection with sodium chloride and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn entero 500 mg bid for 14 days Placebo: Injection with sodium chloride at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days	Control Group: Wait-and-see Treatment Control group: wait-and-see treatment Naprosyn entero 500 mg bid for 14 days Naproxen: Naproxen 500 mg bid for 14 days
Overall Study STARTED	59	58	60
Overall Study COMPLETED	52	53	52
Overall Study NOT COMPLETED	7	5	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Treatment Study of Steroid Injection and Physical Therapy for Acute Lateral Epicondylitis

Baseline characteristics by cohort

Measure	Corticosteroid Injection in Combination With Physical Therapy n=59 Participants Corticosteroid injection in combination with physical therapy Injection with triamcinolone 10 mg and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn Entero 500 mg bid for 14 days triamcinolone: Injection with triamcinolone 10 mg at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days	Placebo Injection in Combination With Physical Therapy n=58 Participants Placebo injection in combination with physical therapy Injection with sodium chloride and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn entero 500 mg bid for 14 days Placebo: Injection with sodium chloride at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days	Control Group: Wait-and-see Treatment n=60 Participants Control group: wait-and-see treatment Naprosyn entero 500 mg bid for 14 days Naproxen: Naproxen 500 mg bid for 14 days	Total n=177 Participants Total of all reporting groups
Age, Continuous	47.9 years STANDARD_DEVIATION 9.6 • n=5 Participants	48.8 years STANDARD_DEVIATION 9.4 • n=7 Participants	44.0 years STANDARD_DEVIATION 9.7 • n=5 Participants	46.9 years STANDARD_DEVIATION 9.7 • n=4 Participants
Sex: Female, Male Female	26 Participants n=5 Participants	20 Participants n=7 Participants	25 Participants n=5 Participants	71 Participants n=4 Participants
Sex: Female, Male Male	33 Participants n=5 Participants	38 Participants n=7 Participants	35 Participants n=5 Participants	106 Participants n=4 Participants
Region of Enrollment Norway	59 participants n=5 Participants	58 participants n=7 Participants	60 participants n=5 Participants	177 participants n=4 Participants

PRIMARY outcome

Timeframe: 6 - 52 weeks

Population: Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs.

Unadjusted event rates of treatment success, defined as participants rating themselves 'much improved' or 'completely recovered' on a six point scale. Percentage with 99% confidence interval.

Outcome measures

Measure	Control Group: Wait-and-see Treatment n=60 Participants Control group: wait-and-see treatment Naprosyn entero 500 mg bid for 14 days Naproxen: Naproxen 500 mg bid for 14 days	Placebo Injection in Combination With Physical Therapy n=58 Participants Placebo injection in combination with physical therapy Injection with sodium chloride and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn entero 500 mg bid for 14 days Placebo: Injection with sodium chloride at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days	Corticosteroid Injection in Combination With Physical Therapy n=59 Participants Corticosteroid injection in combination with physical therapy Injection with triamcinolone 10 mg and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn Entero 500 mg bid for 14 days triamcinolone: Injection with triamcinolone 10 mg at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days
Treatment Success - Event Rates in Each Group 6 weeks	15 percentage of participants Interval 3.0 to 27.0	24 percentage of participants Interval 10.0 to 39.0	59 percentage of participants Interval 43.0 to 76.0
Treatment Success - Event Rates in Each Group 12 weeks	48 percentage of participants Interval 32.0 to 65.0	45 percentage of participants Interval 28.0 to 62.0	42 percentage of participants Interval 26.0 to 59.0
Treatment Success - Event Rates in Each Group 26 weeks	67 percentage of participants Interval 51.0 to 82.0	69 percentage of participants Interval 53.0 to 85.0	42 percentage of participants Interval 26.0 to 59.0
Treatment Success - Event Rates in Each Group 52 weeks	78 percentage of participants Interval 65.0 to 92.0	78 percentage of participants Interval 64.0 to 92.0	75 percentage of participants Interval 60.0 to 89.0

SECONDARY outcome

Timeframe: 6 weeks

Population: Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs.

Pain in elbow as recorded by the study doctors on a 100 mm VAS-scale (Visual Analog Scale). The scale runs from 0 mm (no pain) to 100 mm (maximum pain), higher scores means worse outcome.

Outcome measures

Measure	Control Group: Wait-and-see Treatment n=59 Participants Control group: wait-and-see treatment Naprosyn entero 500 mg bid for 14 days Naproxen: Naproxen 500 mg bid for 14 days	Placebo Injection in Combination With Physical Therapy n=58 Participants Placebo injection in combination with physical therapy Injection with sodium chloride and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn entero 500 mg bid for 14 days Placebo: Injection with sodium chloride at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days	Corticosteroid Injection in Combination With Physical Therapy n=60 Participants Corticosteroid injection in combination with physical therapy Injection with triamcinolone 10 mg and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn Entero 500 mg bid for 14 days triamcinolone: Injection with triamcinolone 10 mg at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days
Pain as Recorded by the Study Doctors on a Visual Analog Scale (VAS Scale)	29 mm Standard Deviation 25	45 mm Standard Deviation 23	44 mm Standard Deviation 25

SECONDARY outcome

Timeframe: 12 weeks

Population: Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs.

Pain in elbow as recorded by the study doctors on a 100 mm VAS-scale (Visual Analog Scale). The scale runs from 0 mm (no pain) to 100 mm (maximum pain), higher scores means worse outcome.

Outcome measures

Measure	Control Group: Wait-and-see Treatment n=59 Participants Control group: wait-and-see treatment Naprosyn entero 500 mg bid for 14 days Naproxen: Naproxen 500 mg bid for 14 days	Placebo Injection in Combination With Physical Therapy n=58 Participants Placebo injection in combination with physical therapy Injection with sodium chloride and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn entero 500 mg bid for 14 days Placebo: Injection with sodium chloride at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days	Corticosteroid Injection in Combination With Physical Therapy n=60 Participants Corticosteroid injection in combination with physical therapy Injection with triamcinolone 10 mg and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn Entero 500 mg bid for 14 days triamcinolone: Injection with triamcinolone 10 mg at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days
Pain as Recorded by the Study Doctors on a 100 mm VAS-scale (Visual Analog Scale).	41 mm Standard Deviation 26	33 mm Standard Deviation 26	33 mm Standard Deviation 26

SECONDARY outcome

Timeframe: 26 weeks

Population: Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs.

Pain in elbow as recorded by the study doctors on a 100 mm VAS-scale (Visual Analog Scale). The scale runs from 0 mm (no pain) to 100 mm (maximum pain), higher scores means worse outcome.

Outcome measures

Measure	Control Group: Wait-and-see Treatment n=59 Participants Control group: wait-and-see treatment Naprosyn entero 500 mg bid for 14 days Naproxen: Naproxen 500 mg bid for 14 days	Placebo Injection in Combination With Physical Therapy n=58 Participants Placebo injection in combination with physical therapy Injection with sodium chloride and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn entero 500 mg bid for 14 days Placebo: Injection with sodium chloride at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days	Corticosteroid Injection in Combination With Physical Therapy n=60 Participants Corticosteroid injection in combination with physical therapy Injection with triamcinolone 10 mg and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn Entero 500 mg bid for 14 days triamcinolone: Injection with triamcinolone 10 mg at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days
Pain as Recorded by the Study Doctors on a 100 mm VAS-scale (Visual Analog Scale).	38 mm Standard Deviation 28	21 mm Standard Deviation 22	19 mm Standard Deviation 22

SECONDARY outcome

Timeframe: 52 weeks

Population: Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs.

Pain in elbow as recorded by the study doctors on a 100 mm VAS-scale (Visual Analog Scale). The scale runs from 0 mm (no pain) to 100 mm (maximum pain), higher scores means worse outcome.

Outcome measures

Measure	Control Group: Wait-and-see Treatment n=59 Participants Control group: wait-and-see treatment Naprosyn entero 500 mg bid for 14 days Naproxen: Naproxen 500 mg bid for 14 days	Placebo Injection in Combination With Physical Therapy n=58 Participants Placebo injection in combination with physical therapy Injection with sodium chloride and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn entero 500 mg bid for 14 days Placebo: Injection with sodium chloride at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days	Corticosteroid Injection in Combination With Physical Therapy n=60 Participants Corticosteroid injection in combination with physical therapy Injection with triamcinolone 10 mg and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn Entero 500 mg bid for 14 days triamcinolone: Injection with triamcinolone 10 mg at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days
Pain as Recorded by the Study Doctors on a 100 mm VAS-scale	19 mm Standard Deviation 23	9 mm Standard Deviation 11	13 mm Standard Deviation 19

SECONDARY outcome

Timeframe: 6 weeks

Population: Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs.

Pain free grip strength registered with hand held dynamometer . Mean of three measurements as ratio of affected to unaffected side.Strength registered in kg. A ratio closer to zero signifies that pain occurs at the application of a small force signifying a more severe condition. A ratio approaching 1 signifies a milder complaint.

Outcome measures

Measure	Control Group: Wait-and-see Treatment n=59 Participants Control group: wait-and-see treatment Naprosyn entero 500 mg bid for 14 days Naproxen: Naproxen 500 mg bid for 14 days	Placebo Injection in Combination With Physical Therapy n=58 Participants Placebo injection in combination with physical therapy Injection with sodium chloride and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn entero 500 mg bid for 14 days Placebo: Injection with sodium chloride at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days	Corticosteroid Injection in Combination With Physical Therapy n=60 Participants Corticosteroid injection in combination with physical therapy Injection with triamcinolone 10 mg and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn Entero 500 mg bid for 14 days triamcinolone: Injection with triamcinolone 10 mg at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days
Pain-free Grip Strength Ratio	58 Ratio x 100 Standard Deviation 35	50 Ratio x 100 Standard Deviation 29	57 Ratio x 100 Standard Deviation 32

SECONDARY outcome

Timeframe: 12 weeks

Population: Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs.

Pain free grip strength registered with hand held dynamometer 30 31. Mean of three measurements as ratio of affected to unaffected side. Strength registered in kg. A ratio closer to zero signifies that pain occurs at the application of a small force signifying a more severe condition. A ratio approaching 1 signifies a milder complaint.

Outcome measures

Measure	Control Group: Wait-and-see Treatment n=59 Participants Control group: wait-and-see treatment Naprosyn entero 500 mg bid for 14 days Naproxen: Naproxen 500 mg bid for 14 days	Placebo Injection in Combination With Physical Therapy n=58 Participants Placebo injection in combination with physical therapy Injection with sodium chloride and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn entero 500 mg bid for 14 days Placebo: Injection with sodium chloride at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days	Corticosteroid Injection in Combination With Physical Therapy n=60 Participants Corticosteroid injection in combination with physical therapy Injection with triamcinolone 10 mg and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn Entero 500 mg bid for 14 days triamcinolone: Injection with triamcinolone 10 mg at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days
Pain-free Grip Strength Ratio	64 Ratio x 100 Standard Deviation 43	55 Ratio x 100 Standard Deviation 25	63 Ratio x 100 Standard Deviation 36

SECONDARY outcome

Timeframe: 26 weeks

Population: Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs.

Pain free grip strength registered with hand held dynamometer 30 31. Mean of three measurements as ratio of affected to unaffected side.Strength registered in kg. A ratio closer to zero signifies that pain occurs at the application of a small force signifying a more severe condition. A ratio approaching 1 signifies a milder complaint.

Outcome measures

Measure	Control Group: Wait-and-see Treatment n=59 Participants Control group: wait-and-see treatment Naprosyn entero 500 mg bid for 14 days Naproxen: Naproxen 500 mg bid for 14 days	Placebo Injection in Combination With Physical Therapy n=58 Participants Placebo injection in combination with physical therapy Injection with sodium chloride and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn entero 500 mg bid for 14 days Placebo: Injection with sodium chloride at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days	Corticosteroid Injection in Combination With Physical Therapy n=60 Participants Corticosteroid injection in combination with physical therapy Injection with triamcinolone 10 mg and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn Entero 500 mg bid for 14 days triamcinolone: Injection with triamcinolone 10 mg at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days
Pain-free Grip Strength Ratio	82 Ratio x 100 Standard Deviation 48	76 Ratio x 100 Standard Deviation 27	74 Ratio x 100 Standard Deviation 37

SECONDARY outcome

Timeframe: 52 weeks

Population: Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs.

Pain free grip strength registered with hand held dynamometer 30 31. Mean of three measurements as ratio of affected to unaffected side.Strength registered in kg. A ratio closer to zero signifies that pain occurs at the application of a small force signifying a more severe condition. A ratio approaching 1 signifies a milder complaint.

Outcome measures

Measure	Control Group: Wait-and-see Treatment n=59 Participants Control group: wait-and-see treatment Naprosyn entero 500 mg bid for 14 days Naproxen: Naproxen 500 mg bid for 14 days	Placebo Injection in Combination With Physical Therapy n=58 Participants Placebo injection in combination with physical therapy Injection with sodium chloride and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn entero 500 mg bid for 14 days Placebo: Injection with sodium chloride at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days	Corticosteroid Injection in Combination With Physical Therapy n=60 Participants Corticosteroid injection in combination with physical therapy Injection with triamcinolone 10 mg and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn Entero 500 mg bid for 14 days triamcinolone: Injection with triamcinolone 10 mg at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days
Pain-free Grip Strength Ratio	100 Ratio x 100 Standard Deviation 33	90 Ratio x 100 Standard Deviation 23	91 Ratio x 100 Standard Deviation 23

SECONDARY outcome

Timeframe: 6 weeks

Population: Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs.

Maximum grip strength registered with hand held dynamometer. Mean of three measurements as ratio of affected to unaffected side. Strength registered in kg. A ratio closer to zero signifies that pain hampers the application of grip force to a larger degree signifying a more severe condition. A ratio approaching 1 signifies a milder complaint where grip strength is not hampered by pain.

Outcome measures

Measure	Control Group: Wait-and-see Treatment n=59 Participants Control group: wait-and-see treatment Naprosyn entero 500 mg bid for 14 days Naproxen: Naproxen 500 mg bid for 14 days	Placebo Injection in Combination With Physical Therapy n=58 Participants Placebo injection in combination with physical therapy Injection with sodium chloride and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn entero 500 mg bid for 14 days Placebo: Injection with sodium chloride at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days	Corticosteroid Injection in Combination With Physical Therapy n=60 Participants Corticosteroid injection in combination with physical therapy Injection with triamcinolone 10 mg and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn Entero 500 mg bid for 14 days triamcinolone: Injection with triamcinolone 10 mg at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days
Maximum Grip Strength Ratio	87 Ratio x 100 Standard Deviation 26	80 Ratio x 100 Standard Deviation 25	74 Ratio x 100 Standard Deviation 27

SECONDARY outcome

Timeframe: 12 weeks

Population: Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs.

Maximum grip strength registered with hand held dynamometer. Mean of three measurements as ratio of affected to unaffected side. Strength registered in kg. A ratio closer to zero signifies that pain hampers the application of grip force to a larger degree signifying a more severe condition. A ratio approaching 1 signifies a milder complaint where grip strength is not hampered by pain.

Outcome measures

Measure	Control Group: Wait-and-see Treatment n=59 Participants Control group: wait-and-see treatment Naprosyn entero 500 mg bid for 14 days Naproxen: Naproxen 500 mg bid for 14 days	Placebo Injection in Combination With Physical Therapy n=58 Participants Placebo injection in combination with physical therapy Injection with sodium chloride and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn entero 500 mg bid for 14 days Placebo: Injection with sodium chloride at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days	Corticosteroid Injection in Combination With Physical Therapy n=60 Participants Corticosteroid injection in combination with physical therapy Injection with triamcinolone 10 mg and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn Entero 500 mg bid for 14 days triamcinolone: Injection with triamcinolone 10 mg at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days
Maximum Grip Strength Ratio	83 Ratio x 100 Standard Deviation 29	88 Ratio x 100 Standard Deviation 23	89 Ratio x 100 Standard Deviation 28

SECONDARY outcome

Timeframe: 26 weeks

Population: Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs.

Maximum grip strength registered with hand held dynamometer. Mean of three measurements as ratio of affected to unaffected side. Strength registered in kg. A ratio closer to zero signifies that pain hampers the application of grip force to a larger degree signifying a more severe condition. A ratio approaching 1 signifies a milder complaint where grip strength is not hampered by pain.

Outcome measures

Measure	Control Group: Wait-and-see Treatment n=59 Participants Control group: wait-and-see treatment Naprosyn entero 500 mg bid for 14 days Naproxen: Naproxen 500 mg bid for 14 days	Placebo Injection in Combination With Physical Therapy n=58 Participants Placebo injection in combination with physical therapy Injection with sodium chloride and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn entero 500 mg bid for 14 days Placebo: Injection with sodium chloride at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days	Corticosteroid Injection in Combination With Physical Therapy n=60 Participants Corticosteroid injection in combination with physical therapy Injection with triamcinolone 10 mg and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn Entero 500 mg bid for 14 days triamcinolone: Injection with triamcinolone 10 mg at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days
Maximum Grip Strength Ratio	89 Ratio x 100 Standard Deviation 27	99 Ratio x 100 Standard Deviation 20	99 Ratio x 100 Standard Deviation 19

SECONDARY outcome

Timeframe: 52 weeks

Population: Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs.

Maximum grip strength registered with hand held dynamometer. Mean of three measurements as ratio of affected to unaffected side.Strength registered in kg. A ratio closer to zero signifies that pain hampers the application of grip force to a larger degree signifying a more severe condition. A ratio approaching 1 signifies a milder complaint where grip strength is not hampered by pain.

Outcome measures

Measure	Control Group: Wait-and-see Treatment n=59 Participants Control group: wait-and-see treatment Naprosyn entero 500 mg bid for 14 days Naproxen: Naproxen 500 mg bid for 14 days	Placebo Injection in Combination With Physical Therapy n=58 Participants Placebo injection in combination with physical therapy Injection with sodium chloride and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn entero 500 mg bid for 14 days Placebo: Injection with sodium chloride at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days	Corticosteroid Injection in Combination With Physical Therapy n=60 Participants Corticosteroid injection in combination with physical therapy Injection with triamcinolone 10 mg and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn Entero 500 mg bid for 14 days triamcinolone: Injection with triamcinolone 10 mg at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days
Maximum Grip Strength Ratio	96 Ratio x 100 Standard Deviation 19	102 Ratio x 100 Standard Deviation 17	104 Ratio x 100 Standard Deviation 15

SECONDARY outcome

Timeframe: 6 weeks

Population: Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs.

To what extent is the use of the elbow affected registered on 100 mm VAS-scale. 0 mm represents use not affected. 100 mm signifies maximum affected function. Higher scores mean a worse outcome.

Outcome measures

Measure	Control Group: Wait-and-see Treatment n=59 Participants Control group: wait-and-see treatment Naprosyn entero 500 mg bid for 14 days Naproxen: Naproxen 500 mg bid for 14 days	Placebo Injection in Combination With Physical Therapy n=58 Participants Placebo injection in combination with physical therapy Injection with sodium chloride and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn entero 500 mg bid for 14 days Placebo: Injection with sodium chloride at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days	Corticosteroid Injection in Combination With Physical Therapy n=60 Participants Corticosteroid injection in combination with physical therapy Injection with triamcinolone 10 mg and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn Entero 500 mg bid for 14 days triamcinolone: Injection with triamcinolone 10 mg at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days
Affected Function on 100 mm VAS-scale as Recorded by the Study Doctors	25 mm Standard Deviation 23	45 mm Standard Deviation 24	38 mm Standard Deviation 26

SECONDARY outcome

Timeframe: 12 weeks

Population: Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs.

To what extent is the use of the elbow affected registered on 100 mm VAS-scale. 0 mm represents use not affected. 100 mm signifies maximum affected function. Higher scores mean a worse outcome.

Outcome measures

Measure	Control Group: Wait-and-see Treatment n=59 Participants Control group: wait-and-see treatment Naprosyn entero 500 mg bid for 14 days Naproxen: Naproxen 500 mg bid for 14 days	Placebo Injection in Combination With Physical Therapy n=58 Participants Placebo injection in combination with physical therapy Injection with sodium chloride and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn entero 500 mg bid for 14 days Placebo: Injection with sodium chloride at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days	Corticosteroid Injection in Combination With Physical Therapy n=60 Participants Corticosteroid injection in combination with physical therapy Injection with triamcinolone 10 mg and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn Entero 500 mg bid for 14 days triamcinolone: Injection with triamcinolone 10 mg at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days
Affected Function on 100 mm VAS-scale as Recorded by the Study Doctors	37 mm Standard Deviation 29	32 mm Standard Deviation 25	34 mm Standard Deviation 28

SECONDARY outcome

Timeframe: 26 weeks

Population: Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs.

To what extent is the use of the elbow affected registered on 100 mm VAS-scale. 0 mm represents use not affected. 100 mm signifies maximum affected function. Higher scores mean a worse outcome.

Outcome measures

Measure	Control Group: Wait-and-see Treatment n=59 Participants Control group: wait-and-see treatment Naprosyn entero 500 mg bid for 14 days Naproxen: Naproxen 500 mg bid for 14 days	Placebo Injection in Combination With Physical Therapy n=58 Participants Placebo injection in combination with physical therapy Injection with sodium chloride and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn entero 500 mg bid for 14 days Placebo: Injection with sodium chloride at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days	Corticosteroid Injection in Combination With Physical Therapy n=60 Participants Corticosteroid injection in combination with physical therapy Injection with triamcinolone 10 mg and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn Entero 500 mg bid for 14 days triamcinolone: Injection with triamcinolone 10 mg at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days
Affected Function on 100 mm VAS-scale as Recorded by the Study Doctors	28 mm Standard Deviation 25	17 mm Standard Deviation 22	16 mm Standard Deviation 20

SECONDARY outcome

Timeframe: 52 weeks

Population: Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs.

To what extent is the use of the elbow affected registered on 100 mm VAS-scale. 0 mm represents use not affected. 100 mm signifies maximum affected function. Higher scores mean a worse outcome.

Outcome measures

Measure	Control Group: Wait-and-see Treatment n=59 Participants Control group: wait-and-see treatment Naprosyn entero 500 mg bid for 14 days Naproxen: Naproxen 500 mg bid for 14 days	Placebo Injection in Combination With Physical Therapy n=58 Participants Placebo injection in combination with physical therapy Injection with sodium chloride and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn entero 500 mg bid for 14 days Placebo: Injection with sodium chloride at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days	Corticosteroid Injection in Combination With Physical Therapy n=60 Participants Corticosteroid injection in combination with physical therapy Injection with triamcinolone 10 mg and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn Entero 500 mg bid for 14 days triamcinolone: Injection with triamcinolone 10 mg at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days
Affected Function on a 100 mm VAS-scale as Recorded by the Study Doctors	16 mm Standard Deviation 22	9 mm Standard Deviation 15	10 mm Standard Deviation 17

SECONDARY outcome

Timeframe: 6 weeks

Population: Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs.

Overall complaint registered on VAS-scale as recorded by study doctors. 0 mm represents no overall complaint. 100 mm signifies maximum overall complaint. Higher scores mean a worse outcome.

Outcome measures

Measure	Control Group: Wait-and-see Treatment n=59 Participants Control group: wait-and-see treatment Naprosyn entero 500 mg bid for 14 days Naproxen: Naproxen 500 mg bid for 14 days	Placebo Injection in Combination With Physical Therapy n=58 Participants Placebo injection in combination with physical therapy Injection with sodium chloride and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn entero 500 mg bid for 14 days Placebo: Injection with sodium chloride at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days	Corticosteroid Injection in Combination With Physical Therapy n=60 Participants Corticosteroid injection in combination with physical therapy Injection with triamcinolone 10 mg and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn Entero 500 mg bid for 14 days triamcinolone: Injection with triamcinolone 10 mg at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days
Overall Complaint on 100 mm VAS-scale as Recorded by the Study Doctors	32 mm Standard Deviation 26	50 mm Standard Deviation 26	51 mm Standard Deviation 28

SECONDARY outcome

Timeframe: 12 weeks

Population: Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs.

Overall complaint registered on VAS-scale as recorded by study doctors. 0 mm represents no overall complaint. 100 mm signifies maximum overall complaint. Higher scores mean a worse outcome.

Outcome measures

Measure	Control Group: Wait-and-see Treatment n=59 Participants Control group: wait-and-see treatment Naprosyn entero 500 mg bid for 14 days Naproxen: Naproxen 500 mg bid for 14 days	Placebo Injection in Combination With Physical Therapy n=58 Participants Placebo injection in combination with physical therapy Injection with sodium chloride and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn entero 500 mg bid for 14 days Placebo: Injection with sodium chloride at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days	Corticosteroid Injection in Combination With Physical Therapy n=60 Participants Corticosteroid injection in combination with physical therapy Injection with triamcinolone 10 mg and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn Entero 500 mg bid for 14 days triamcinolone: Injection with triamcinolone 10 mg at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days
Overall Complaint on 100 mm VAS-scale as Recorded by the Study Doctors	43 mm Standard Deviation 30	35 mm Standard Deviation 28	36 mm Standard Deviation 27

SECONDARY outcome

Timeframe: 26 weeks

Population: Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs.

Overall complaint registered on VAS-scale as recorded by study doctors. 0 mm represents no overall complaint. 100 mm signifies maximum overall complaint. Higher scores mean a worse outcome.

Outcome measures

Measure	Control Group: Wait-and-see Treatment n=59 Participants Control group: wait-and-see treatment Naprosyn entero 500 mg bid for 14 days Naproxen: Naproxen 500 mg bid for 14 days	Placebo Injection in Combination With Physical Therapy n=58 Participants Placebo injection in combination with physical therapy Injection with sodium chloride and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn entero 500 mg bid for 14 days Placebo: Injection with sodium chloride at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days	Corticosteroid Injection in Combination With Physical Therapy n=60 Participants Corticosteroid injection in combination with physical therapy Injection with triamcinolone 10 mg and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn Entero 500 mg bid for 14 days triamcinolone: Injection with triamcinolone 10 mg at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days
Overall Complaint on 100 mm VAS-scale as Recorded by the Study Doctors	36 mm Standard Deviation 26	19 mm Standard Deviation 23	18 mm Standard Deviation 20

SECONDARY outcome

Timeframe: 52 weeks

Population: Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs.

Overall complaint registered on VAS-scale as recorded by study doctors. 0 mm represents no overall complaint. 100 mm signifies maximum overall complaint. Higher scores mean a worse outcome.

Outcome measures

Measure	Control Group: Wait-and-see Treatment n=59 Participants Control group: wait-and-see treatment Naprosyn entero 500 mg bid for 14 days Naproxen: Naproxen 500 mg bid for 14 days	Placebo Injection in Combination With Physical Therapy n=58 Participants Placebo injection in combination with physical therapy Injection with sodium chloride and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn entero 500 mg bid for 14 days Placebo: Injection with sodium chloride at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days	Corticosteroid Injection in Combination With Physical Therapy n=60 Participants Corticosteroid injection in combination with physical therapy Injection with triamcinolone 10 mg and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn Entero 500 mg bid for 14 days triamcinolone: Injection with triamcinolone 10 mg at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days
Overall Complaint on 100 mm VAS-scale as Recorded by the Study Doctors	20 mm Standard Deviation 24	9 mm Standard Deviation 13	12 mm Standard Deviation 19

SECONDARY outcome

Timeframe: 6 weeks

Population: Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs.

Pain free function Index ( 0 - 8 ; 0: full function, 8 no function). Does the patient have pain on 8 every-day activities (dressing, eating, washing, household tasks, opening doors, carrying objects, with work, at sports). Recording a 0 on a complaint listed signifies full function, recording a 1 signifies no function. Thus the more activities with no function the higher score and the higher impairment.

Outcome measures

Measure	Control Group: Wait-and-see Treatment n=59 Participants Control group: wait-and-see treatment Naprosyn entero 500 mg bid for 14 days Naproxen: Naproxen 500 mg bid for 14 days	Placebo Injection in Combination With Physical Therapy n=58 Participants Placebo injection in combination with physical therapy Injection with sodium chloride and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn entero 500 mg bid for 14 days Placebo: Injection with sodium chloride at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days	Corticosteroid Injection in Combination With Physical Therapy n=60 Participants Corticosteroid injection in combination with physical therapy Injection with triamcinolone 10 mg and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn Entero 500 mg bid for 14 days triamcinolone: Injection with triamcinolone 10 mg at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days
Pain Free Function Index of Everyday Activities	2.78 score on a scale Standard Deviation 2.22	4.40 score on a scale Standard Deviation 2.01	4.82 score on a scale Standard Deviation 2.16

SECONDARY outcome

Timeframe: 12 weeks

Population: Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs.

Pain free function Index ( 0 - 8 ; 0: full function, 8 no function). Does the patient have pain on 8 every-day activities (dressing, eating, washing, household tasks, opening doors, carrying objects, with work, at sports). Recording a 0 on a complaint listed signifies full function, recording a 1 signifies no function. Thus the more activities with no function the higher score and the higher impairment.

Outcome measures

Measure	Control Group: Wait-and-see Treatment n=59 Participants Control group: wait-and-see treatment Naprosyn entero 500 mg bid for 14 days Naproxen: Naproxen 500 mg bid for 14 days	Placebo Injection in Combination With Physical Therapy n=58 Participants Placebo injection in combination with physical therapy Injection with sodium chloride and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn entero 500 mg bid for 14 days Placebo: Injection with sodium chloride at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days	Corticosteroid Injection in Combination With Physical Therapy n=60 Participants Corticosteroid injection in combination with physical therapy Injection with triamcinolone 10 mg and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn Entero 500 mg bid for 14 days triamcinolone: Injection with triamcinolone 10 mg at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days
Pain Free Function Index of Everyday Activities	3.42 score on a scale Standard Deviation 2.63	3.62 score on a scale Standard Deviation 2.43	3.37 score on a scale Standard Deviation 2.36

SECONDARY outcome

Timeframe: 26 weeks

Population: Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs.

Pain free function Index ( 0 - 8 ; 0: full function, 8 no function). Does the patient have pain on 8 every-day activities (dressing, eating, washing, household tasks, opening doors, carrying objects, with work, at sports). Recording a 0 on a complaint listed signifies full function, recording a 1 signifies no function. Thus the more activities with no function the higher score and the higher impairment.

Outcome measures

Measure	Control Group: Wait-and-see Treatment n=59 Participants Control group: wait-and-see treatment Naprosyn entero 500 mg bid for 14 days Naproxen: Naproxen 500 mg bid for 14 days	Placebo Injection in Combination With Physical Therapy n=58 Participants Placebo injection in combination with physical therapy Injection with sodium chloride and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn entero 500 mg bid for 14 days Placebo: Injection with sodium chloride at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days	Corticosteroid Injection in Combination With Physical Therapy n=60 Participants Corticosteroid injection in combination with physical therapy Injection with triamcinolone 10 mg and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn Entero 500 mg bid for 14 days triamcinolone: Injection with triamcinolone 10 mg at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days
Pain Free Function Index of Everyday Activities	2.97 score on a scale Standard Deviation 2.53	1.83 score on a scale Standard Deviation 2.08	2.00 score on a scale Standard Deviation 2.25

SECONDARY outcome

Timeframe: 52 weeks

Population: Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs.

Pain free function Index ( 0 - 8 ; 0: full function, 8 no function). Does the patient have pain on 8 every-day activities (dressing, eating, washing, household tasks, opening doors, carrying objects, with work, at sports). Recording a 0 on a complaint listed signifies full function, recording a 1 signifies no function. Thus the more activities with no function the higher score and the higher impairment.

Outcome measures

Measure	Control Group: Wait-and-see Treatment n=59 Participants Control group: wait-and-see treatment Naprosyn entero 500 mg bid for 14 days Naproxen: Naproxen 500 mg bid for 14 days	Placebo Injection in Combination With Physical Therapy n=58 Participants Placebo injection in combination with physical therapy Injection with sodium chloride and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn entero 500 mg bid for 14 days Placebo: Injection with sodium chloride at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days	Corticosteroid Injection in Combination With Physical Therapy n=60 Participants Corticosteroid injection in combination with physical therapy Injection with triamcinolone 10 mg and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn Entero 500 mg bid for 14 days triamcinolone: Injection with triamcinolone 10 mg at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days
Pain Free Function Index of Everyday Activities	1.64 score on a scale Standard Deviation 2.04	1.03 score on a scale Standard Deviation 1.67	1.40 score on a scale Standard Deviation 1.90

SECONDARY outcome

Timeframe: 6 weeks

Population: Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs.

Percentage of patients reporting "no pain" on dorsiflexion of wrist on a three-point Likert scale on dorsiflexion of wrist. Scale: No pain - some pain - definite pain.

Outcome measures

Measure	Control Group: Wait-and-see Treatment n=59 Participants Control group: wait-and-see treatment Naprosyn entero 500 mg bid for 14 days Naproxen: Naproxen 500 mg bid for 14 days	Placebo Injection in Combination With Physical Therapy n=58 Participants Placebo injection in combination with physical therapy Injection with sodium chloride and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn entero 500 mg bid for 14 days Placebo: Injection with sodium chloride at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days	Corticosteroid Injection in Combination With Physical Therapy n=60 Participants Corticosteroid injection in combination with physical therapy Injection with triamcinolone 10 mg and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn Entero 500 mg bid for 14 days triamcinolone: Injection with triamcinolone 10 mg at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days
No Pain on Three Point Likert Scale on Dorsiflexion of Wrist	36 percentage of participants Interval 20.0 to 52.0	3 percentage of participants Interval -3.0 to 10.0	8 percentage of participants Interval -1.0 to 18.0

SECONDARY outcome

Timeframe: 12 weeks

Population: Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs.

Percentage of patients reporting "no pain" on dorsiflexion of wrist on a three-point Likert scale on dorsiflexion of wrist. Scale: No pain - some pain - definite pain.

Outcome measures

Measure	Control Group: Wait-and-see Treatment n=59 Participants Control group: wait-and-see treatment Naprosyn entero 500 mg bid for 14 days Naproxen: Naproxen 500 mg bid for 14 days	Placebo Injection in Combination With Physical Therapy n=58 Participants Placebo injection in combination with physical therapy Injection with sodium chloride and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn entero 500 mg bid for 14 days Placebo: Injection with sodium chloride at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days	Corticosteroid Injection in Combination With Physical Therapy n=60 Participants Corticosteroid injection in combination with physical therapy Injection with triamcinolone 10 mg and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn Entero 500 mg bid for 14 days triamcinolone: Injection with triamcinolone 10 mg at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days
No Pain on Three Point Likert Scale on Dorsiflexion of Wrist	22 percentage of patients Interval 8.0 to 36.0	12 percentage of patients Interval 1.0 to 23.0	17 percentage of patients Interval 4.0 to 29.0

SECONDARY outcome

Timeframe: 26 weeks

Population: Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs.

Percentage of patients reporting "no pain" on dorsiflexion of wrist on a three-point Likert scale on dorsiflexion of wrist. Scale: No pain - some pain - definite pain.

Outcome measures

Measure	Control Group: Wait-and-see Treatment n=59 Participants Control group: wait-and-see treatment Naprosyn entero 500 mg bid for 14 days Naproxen: Naproxen 500 mg bid for 14 days	Placebo Injection in Combination With Physical Therapy n=58 Participants Placebo injection in combination with physical therapy Injection with sodium chloride and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn entero 500 mg bid for 14 days Placebo: Injection with sodium chloride at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days	Corticosteroid Injection in Combination With Physical Therapy n=60 Participants Corticosteroid injection in combination with physical therapy Injection with triamcinolone 10 mg and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn Entero 500 mg bid for 14 days triamcinolone: Injection with triamcinolone 10 mg at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days
No Pain on Three Point Likert Scale on Dorsiflexion of Wrist	19 percentage of patients Interval 6.0 to 32.0	29 percentage of patients Interval 14.0 to 45.0	38 percentage of patients Interval 22.0 to 54.0

SECONDARY outcome

Timeframe: 52 weeks

Population: Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs.

Percentage of patients reporting "no pain" on dorsiflexion of wrist on a three-point Likert scale on dorsiflexion of wrist. Scale: No pain - some pain - definite pain.

Outcome measures

Measure	Control Group: Wait-and-see Treatment n=59 Participants Control group: wait-and-see treatment Naprosyn entero 500 mg bid for 14 days Naproxen: Naproxen 500 mg bid for 14 days	Placebo Injection in Combination With Physical Therapy n=58 Participants Placebo injection in combination with physical therapy Injection with sodium chloride and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn entero 500 mg bid for 14 days Placebo: Injection with sodium chloride at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days	Corticosteroid Injection in Combination With Physical Therapy n=60 Participants Corticosteroid injection in combination with physical therapy Injection with triamcinolone 10 mg and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn Entero 500 mg bid for 14 days triamcinolone: Injection with triamcinolone 10 mg at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days
No Pain on Three Point Likert Scale on Dorsiflexion of Wrist	36 percentage of patients Interval 20.0 to 52.0	60 percentage of patients Interval 4.0 to 77.0	50 percentage of patients Interval 33.0 to 67.0

SECONDARY outcome

Timeframe: 6 weeks

Population: Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs.

Percentage of patients reporting "no pain" on isometric extension of third finger on a three-point Likert scale on dorsiflexion of wrist. Scale: No pain - some pain - definite pain.

Outcome measures

Measure	Control Group: Wait-and-see Treatment n=59 Participants Control group: wait-and-see treatment Naprosyn entero 500 mg bid for 14 days Naproxen: Naproxen 500 mg bid for 14 days	Placebo Injection in Combination With Physical Therapy n=58 Participants Placebo injection in combination with physical therapy Injection with sodium chloride and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn entero 500 mg bid for 14 days Placebo: Injection with sodium chloride at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days	Corticosteroid Injection in Combination With Physical Therapy n=60 Participants Corticosteroid injection in combination with physical therapy Injection with triamcinolone 10 mg and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn Entero 500 mg bid for 14 days triamcinolone: Injection with triamcinolone 10 mg at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days
No Pain on Three Point Likert Scale on Isometric Extension of Third Finger	44 percentage of patients Interval 27.0 to 61.0	16 percentage of patients Interval 3.0 to 28.0	17 percentage of patients Interval 4.0 to 29.0

SECONDARY outcome

Timeframe: 12 weeks

Population: Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs.

Percentage of patients reporting "no pain" on isometric extension of third finger on a three-point Likert scale on dorsiflexion of wrist. Scale: No pain - some pain - definite pain.

Outcome measures

Measure	Control Group: Wait-and-see Treatment n=59 Participants Control group: wait-and-see treatment Naprosyn entero 500 mg bid for 14 days Naproxen: Naproxen 500 mg bid for 14 days	Placebo Injection in Combination With Physical Therapy n=58 Participants Placebo injection in combination with physical therapy Injection with sodium chloride and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn entero 500 mg bid for 14 days Placebo: Injection with sodium chloride at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days	Corticosteroid Injection in Combination With Physical Therapy n=60 Participants Corticosteroid injection in combination with physical therapy Injection with triamcinolone 10 mg and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn Entero 500 mg bid for 14 days triamcinolone: Injection with triamcinolone 10 mg at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days
No Pain on Three Point Likert Scale on Isometric Extension of Third Finger	36 percentage of patients Interval 20.0 to 52.0	24 percentage of patients Interval 10.0 to 39.0	22 percentage of patients Interval 8.0 to 35.0

SECONDARY outcome

Timeframe: 26 weeks

Population: Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs.

Percentage of patients reporting "no pain" on isometric extension of third finger on a three-point Likert scale on dorsiflexion of wrist. Scale: No pain - some pain - definite pain.

Outcome measures

Measure	Control Group: Wait-and-see Treatment n=59 Participants Control group: wait-and-see treatment Naprosyn entero 500 mg bid for 14 days Naproxen: Naproxen 500 mg bid for 14 days	Placebo Injection in Combination With Physical Therapy n=58 Participants Placebo injection in combination with physical therapy Injection with sodium chloride and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn entero 500 mg bid for 14 days Placebo: Injection with sodium chloride at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days	Corticosteroid Injection in Combination With Physical Therapy n=60 Participants Corticosteroid injection in combination with physical therapy Injection with triamcinolone 10 mg and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn Entero 500 mg bid for 14 days triamcinolone: Injection with triamcinolone 10 mg at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days
No Pain on Three Point Likert Scale on Isometric Extension of Third Finger	31 percentage of patients Interval 15.0 to 46.0	53 percentage of patients Interval 37.0 to 70.0	58 percentage of patients Interval 42.0 to 75.0

SECONDARY outcome

Timeframe: 52 weeks

Population: Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs.

Percentage of patients reporting "no pain" on isometric extension of third finger on a three-point Likert scale on dorsiflexion of wrist. Scale: No pain - some pain - definite pain.

Outcome measures

Measure	Control Group: Wait-and-see Treatment n=59 Participants Control group: wait-and-see treatment Naprosyn entero 500 mg bid for 14 days Naproxen: Naproxen 500 mg bid for 14 days	Placebo Injection in Combination With Physical Therapy n=58 Participants Placebo injection in combination with physical therapy Injection with sodium chloride and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn entero 500 mg bid for 14 days Placebo: Injection with sodium chloride at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days	Corticosteroid Injection in Combination With Physical Therapy n=60 Participants Corticosteroid injection in combination with physical therapy Injection with triamcinolone 10 mg and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn Entero 500 mg bid for 14 days triamcinolone: Injection with triamcinolone 10 mg at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days
No Pain on Three Point Likert Scale on Isometric Extension of Third Finger	53 percentage of patients Interval 36.0 to 69.0	76 percentage of patients Interval 61.0 to 90.0	63 percentage of patients Interval 47.0 to 79.0

Adverse Events

Corticosteroid Injection in Combination With Physical Therapy

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Placebo Injection in Combination With Physical Therapy

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Control Group: Wait-and-see Treatment

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Corticosteroid Injection in Combination With Physical Therapy n=59 participants at risk Corticosteroid injection in combination with physical therapy Injection with triamcinolone 10 mg and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn Entero 500 mg bid for 14 days triamcinolone: Injection with triamcinolone 10 mg at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days	Placebo Injection in Combination With Physical Therapy n=58 participants at risk Placebo injection in combination with physical therapy Injection with sodium chloride and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn entero 500 mg bid for 14 days Placebo: Injection with sodium chloride at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days	Control Group: Wait-and-see Treatment n=60 participants at risk Control group: wait-and-see treatment Naprosyn entero 500 mg bid for 14 days Naproxen: Naproxen 500 mg bid for 14 days
Musculoskeletal and connective tissue disorders Increased pain	0.00% 0/59 • 1 year	3.4% 2/58 • 1 year	3.3% 2/60 • 1 year
Gastrointestinal disorders GI side effects	10.2% 6/59 • 1 year	5.2% 3/58 • 1 year	13.3% 8/60 • 1 year
Skin and subcutaneous tissue disorders Skin atrophy	0.00% 0/59 • 1 year	0.00% 0/58 • 1 year	0.00% 0/60 • 1 year

Additional Information

Professor Morten Lindbaek

University of Oslo

Phone: +47-22850646

Email: morten.lindbak@medisin.uio.no

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place