Trial Outcomes & Findings for Dry Needling in Patients With Chronic Neck Pain (NCT NCT02435966)
NCT ID: NCT02435966
Last Updated: 2015-09-07
Results Overview
The Visual Analogue Scale is a validated, self-reported instrument to assess pain, with scores ranging from 0 (no pain) to 10 (maximum pain). We assess the change in chronic neck pain after 30 days, after to interventions in days 1 and 7) as compared to the baseline VAS
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
131 participants
Primary outcome timeframe
Pre-intervention (Day 1); After 1st intervention (Day 1); after 2nd intervention (7 days later); after followup (30 days later)
Results posted on
2015-09-07
Participant Flow
Recruitment took place between May 2013 and June 2014 at Physios, a private physiotherapy practice in central Madrid (Spain)
No significant event here
Participant milestones
| Measure |
Manual Therapy + Dry Needling
Manual therapy + Dry needling: 2 sessions, after a 7 days interval
Dry needling: Dry needling of the most active trigger point either in the upper trapezius or the levator scapulae with 40mm x 0,32mm ener-qi guided needles (EQ1132)
Manual therapy: Standard manual therapy in the upper trapezius or the levator scapulae
|
Manual Therapy + Sham Dry Needling
Manual therapy + Sham Dry needling: after a 7 days interval
Sham Dry needling: Sham Dry needling with a retractile needle (Park Sham Placebo Acupuncture Device) of the most active trigger point either in the upper trapezius or the levator scapulae
Manual therapy: Standard manual therapy in the upper trapezius or the levator scapulae
|
Untreated Control
Natural history of the condition
|
|---|---|---|---|
|
Overall Study
STARTED
|
47
|
54
|
30
|
|
Overall Study
First Intervention
|
47
|
54
|
30
|
|
Overall Study
Second Intervention
|
47
|
53
|
30
|
|
Overall Study
Follow-up
|
47
|
53
|
30
|
|
Overall Study
COMPLETED
|
47
|
53
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Manual Therapy + Dry Needling
Manual therapy + Dry needling: 2 sessions, after a 7 days interval
Dry needling: Dry needling of the most active trigger point either in the upper trapezius or the levator scapulae with 40mm x 0,32mm ener-qi guided needles (EQ1132)
Manual therapy: Standard manual therapy in the upper trapezius or the levator scapulae
|
Manual Therapy + Sham Dry Needling
Manual therapy + Sham Dry needling: after a 7 days interval
Sham Dry needling: Sham Dry needling with a retractile needle (Park Sham Placebo Acupuncture Device) of the most active trigger point either in the upper trapezius or the levator scapulae
Manual therapy: Standard manual therapy in the upper trapezius or the levator scapulae
|
Untreated Control
Natural history of the condition
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
Baseline Characteristics
Dry Needling in Patients With Chronic Neck Pain
Baseline characteristics by cohort
| Measure |
Manual Therapy + Dry Needling
n=47 Participants
Manual therapy + Dry needling: 2 sessions, after a 7 days interval
Dry needling: Dry needling of the most active trigger point either in the upper trapezius or the levator scapulae with 40mm x 0,32mm ener-qi guided needles (EQ1132)
Manual therapy: Standard manual therapy in the upper trapezius or the levator scapulae
|
Manual Therapy + Sham Dry Needling
n=54 Participants
Manual therapy + Sham Dry needling: after a 7 days interval
Sham Dry needling: Sham Dry needling with a retractile needle (Park Sham Placebo Acupuncture Device) of the most active trigger point either in the upper trapezius or the levator scapulae
Manual therapy: Standard manual therapy in the upper trapezius or the levator scapulae
|
Untreated Control
n=30 Participants
Natural history of the condition
|
Total
n=131 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
34.13 years
STANDARD_DEVIATION 7.64 • n=93 Participants
|
34.64 years
STANDARD_DEVIATION 8.88 • n=4 Participants
|
31.37 years
STANDARD_DEVIATION 9.33 • n=27 Participants
|
34.62 years
STANDARD_DEVIATION 8.51 • n=483 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=93 Participants
|
30 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
80 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=93 Participants
|
24 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
51 Participants
n=483 Participants
|
|
Visual Analogue Scale
|
6.66 units on a scale
STANDARD_DEVIATION 1.37 • n=93 Participants
|
6.17 units on a scale
STANDARD_DEVIATION 1.60 • n=4 Participants
|
6.57 units on a scale
STANDARD_DEVIATION 1.33 • n=27 Participants
|
6.44 units on a scale
STANDARD_DEVIATION 1.46 • n=483 Participants
|
|
Pressure Pain Threshold at the most active trigger point
|
1.75 kg/cm2
STANDARD_DEVIATION 0.37 • n=93 Participants
|
1.88 kg/cm2
STANDARD_DEVIATION 0.52 • n=4 Participants
|
1.83 kg/cm2
STANDARD_DEVIATION 0.43 • n=27 Participants
|
1.82 kg/cm2
STANDARD_DEVIATION 0.45 • n=483 Participants
|
|
Range of Motion (Neck): Rotation Left
|
71.78 degrees
STANDARD_DEVIATION 17.73 • n=93 Participants
|
73.81 degrees
STANDARD_DEVIATION 11.82 • n=4 Participants
|
78.20 degrees
STANDARD_DEVIATION 11.21 • n=27 Participants
|
74.09 degrees
STANDARD_DEVIATION 14.23 • n=483 Participants
|
|
Range of Motion (Neck): Rotation Rigth
|
74.27 degrees
STANDARD_DEVIATION 18.10 • n=93 Participants
|
74.60 degrees
STANDARD_DEVIATION 15.31 • n=4 Participants
|
78.20 degrees
STANDARD_DEVIATION 11.21 • n=27 Participants
|
76.24 degrees
STANDARD_DEVIATION 15.49 • n=483 Participants
|
|
Range of Motion (Neck): Flexion
|
67.89 degrees
STANDARD_DEVIATION 13.53 • n=93 Participants
|
69.24 degrees
STANDARD_DEVIATION 11.05 • n=4 Participants
|
65.96 degrees
STANDARD_DEVIATION 8.82 • n=27 Participants
|
68.00 degrees
STANDARD_DEVIATION 11.56 • n=483 Participants
|
|
Range of Motion (Neck): Extension
|
52.31 degrees
STANDARD_DEVIATION 14.56 • n=93 Participants
|
55.67 degrees
STANDARD_DEVIATION 11.54 • n=4 Participants
|
59.66 degrees
STANDARD_DEVIATION 9.30 • n=27 Participants
|
55.38 degrees
STANDARD_DEVIATION 12.50 • n=483 Participants
|
|
Range of Motion (Neck): Inclination Left
|
53.63 degrees
STANDARD_DEVIATION 10.83 • n=93 Participants
|
55.43 degrees
STANDARD_DEVIATION 10.99 • n=4 Participants
|
52.43 degrees
STANDARD_DEVIATION 8.44 • n=27 Participants
|
54.09 degrees
STANDARD_DEVIATION 10.39 • n=483 Participants
|
|
Range of Motion (Neck): Inclination Rigth
|
47.72 degrees
STANDARD_DEVIATION 14.28 • n=93 Participants
|
49.03 degrees
STANDARD_DEVIATION 13.09 • n=4 Participants
|
45.63 degrees
STANDARD_DEVIATION 6.78 • n=27 Participants
|
47.77 degrees
STANDARD_DEVIATION 12.40 • n=483 Participants
|
PRIMARY outcome
Timeframe: Pre-intervention (Day 1); After 1st intervention (Day 1); after 2nd intervention (7 days later); after followup (30 days later)The Visual Analogue Scale is a validated, self-reported instrument to assess pain, with scores ranging from 0 (no pain) to 10 (maximum pain). We assess the change in chronic neck pain after 30 days, after to interventions in days 1 and 7) as compared to the baseline VAS
Outcome measures
| Measure |
Manual Therapy + Dry Needling
n=47 Participants
Manual therapy + Dry needling: 2 sessions, after a 7 days interval
Dry needling: Dry needling of the most active trigger point either in the upper trapezius or the levator scapulae with 40mm x 0,32mm ener-qi guided needles (EQ1132)
Manual therapy: Standard manual therapy in the upper trapezius or the levator scapulae
|
Manual Therapy + Sham Dry Needling
n=54 Participants
Manual therapy + Sham Dry needling: after a 7 days interval
Sham Dry needling: Sham Dry needling with a retractile needle (Park Sham Placebo Acupuncture Device) of the most active trigger point either in the upper trapezius or the levator scapulae
Manual therapy: Standard manual therapy in the upper trapezius or the levator scapulae
|
Untreated Control
n=30 Participants
Natural history of the condition
|
|---|---|---|---|
|
Change in Pain Scores on the Visual Analog Scale (VAS: 0-10) After 30 Days
|
1.77 units on a scale
Standard Deviation 1.38
|
3.34 units on a scale
Standard Deviation 1.92
|
8.83 units on a scale
Standard Deviation 1.64
|
SECONDARY outcome
Timeframe: Pre-intervention (Day 1); After 1st intervention (Day 1); after 2nd intervention (7 days later); after followup (30 days later)Measured by algometer, with the standard measurement procedure
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-intervention (Day 1); After 1st intervention (Day 1); after 2nd intervention (7 days later); after followup (30 days later)Measured by goniometer, with the standard measurement procedure
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-intervention (Day 1); after 2nd intervention (7 days)Outcome measures
Outcome data not reported
Adverse Events
Manual Therapy + Dry Needling
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Manual Therapy + Sham Dry Needling
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Untreated Control
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
Gracia M. Gallego, M.Sc.
Physios & Universidad Europea de Madrid
Phone: +34 609036607
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place