Trial Outcomes & Findings for Evaluation of Efficacy and Hypothalamus-pituitary-adrenal Axis Suppression Due to Corticosteroids Intrabursal Injection (NCT NCT01652495)

Results Overview

Patients will be evaluated clinically by Constant Score Constant score: range 0 (total shoulder impairment) to 100 (non impaired shoulder). The score is obtained from two subjective (pain and relation between pain and daily-life activities) - and two objective physician-assessed (strength and range of motion) measurements Reference: Constant CR and Murley AH. A clinical method of functional assessment of the shoulder. Clin Orthop Relat Res. 1987 Jan;(214):160-4.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

44 participants

Primary outcome timeframe

180 days after treatment

Results posted on

2014-09-01

Participant Flow

Participant milestones

Participant milestones
Measure	Methylprednisolone Acetate Group Single intrabursal injection of methylprednisolone acetate methylprednisolone acetate: Single intrabursal ultrasound guided injection	Triamcinolone Acetonide Group Single intrabursal injection of Triamcinolone acetonide Triamcinolone Acetonide: Single intrabursal ultrasound guided injection
Overall Study STARTED	22	22
Overall Study COMPLETED	20	20
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of Efficacy and Hypothalamus-pituitary-adrenal Axis Suppression Due to Corticosteroids Intrabursal Injection

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Methylprednisolone Acetate n=20 Participants Single intrabursal injection of 40 mg (1 ml) of methylprednisolone acetate	Triamcinolone Acetonide n=20 Participants Single intrabursal injection of 40 mg (1 ml) of trimacinolone acetonide	Total n=40 Participants Total of all reporting groups
Sex: Female, Male Male	6 Participants n=5 Participants	12 Participants n=7 Participants	18 Participants n=5 Participants
Region of Enrollment Italy	20 participants n=5 Participants	20 participants n=7 Participants	40 participants n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=5 Participants	20 Participants n=7 Participants	40 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	51.05 years STANDARD_DEVIATION 6.67 • n=5 Participants	46.35 years STANDARD_DEVIATION 7.27 • n=7 Participants	48.70 years STANDARD_DEVIATION 7.29 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	8 Participants n=7 Participants	22 Participants n=5 Participants

PRIMARY outcome

Timeframe: 180 days after treatment

Patients will be evaluated clinically by Constant Score Constant score: range 0 (total shoulder impairment) to 100 (non impaired shoulder). The score is obtained from two subjective (pain and relation between pain and daily-life activities) - and two objective physician-assessed (strength and range of motion) measurements Reference: Constant CR and Murley AH. A clinical method of functional assessment of the shoulder. Clin Orthop Relat Res. 1987 Jan;(214):160-4.

Outcome measures

Outcome measures
Measure	Methylprednisolone Acetate Group n=20 Participants Single intrabursal injection of methylprednisolone acetate methylprednisolone acetate: Single intrabursal ultrasound guided injection	Triamcinolone Acetonide Group n=20 Participants Single intrabursal injection of Triamcinolone acetonide Triamcinolone Acetonide: Single intrabursal ultrasound guided injection
Functional Improvement Measured According to Percentage Change in Constant Score	99 percentage of improvement Constant score Interval 97.0 to 100.0	95 percentage of improvement Constant score Interval 93.0 to 97.0

SECONDARY outcome

Timeframe: 45 days after treatment

Evaluation of blood cortisol and ACTH, free urinary cortisol, urinary levels of methylprednisolone or triamcinolone (depending on the administered drug) by RIA immunoassay and tandem mass assays Persistent suppression of the HPA axis at the end of the follow up is based on the evidence of ACTH, plasmatic and urinary cortisol levels under reference values

Outcome measures

Outcome measures
Measure	Methylprednisolone Acetate Group n=20 Participants Single intrabursal injection of methylprednisolone acetate methylprednisolone acetate: Single intrabursal ultrasound guided injection	Triamcinolone Acetonide Group n=20 Participants Single intrabursal injection of Triamcinolone acetonide Triamcinolone Acetonide: Single intrabursal ultrasound guided injection
Percentage of Patients With Suppression of Hypothalamus-pituitary-adrenal Axis	0 % of patients with HPA suppression	15 % of patients with HPA suppression

SECONDARY outcome

Timeframe: 180 days after treatment

VAS score VAS score is a 10 -cm graduated scale with scores ranging from 0 (no pain) to 10 (unbearable pain) self- reported by patients Reference: Langley GB and Sheppeard H. The visual analogue scale: its use in pain measurement. Rheumatol Int 1985;5(4):145-148.

Outcome measures

Outcome measures
Measure	Methylprednisolone Acetate Group n=20 Participants Single intrabursal injection of methylprednisolone acetate methylprednisolone acetate: Single intrabursal ultrasound guided injection	Triamcinolone Acetonide Group n=20 Participants Single intrabursal injection of Triamcinolone acetonide Triamcinolone Acetonide: Single intrabursal ultrasound guided injection
Reduction of Pain Severity Expressed as Percentage Change in VAS Score	82 percentage of pain reduction Interval 73.0 to 91.0	96 percentage of pain reduction Interval 87.0 to 100.0

Adverse Events

Methylprednisolone Acetate Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Triamcinolone Acetonide Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Milva Battaglia, Director of Clinical Trials

Istituto Ortopedico Rizzoli

Phone: 0516366026

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place