Trial Outcomes & Findings for Effectiveness of Dry Needling and Physical Therapy Versus Physical Therapy Alone Following Shoulder Stabilization Repair (NCT NCT02704975)
NCT ID: NCT02704975
Last Updated: 2025-11-10
Results Overview
Subject is supine on the plinth with hips and knees flexed for stabilization. Tested arm abducted to 90 degrees, elbow flexed to 90 degrees, forearm in the midposition between supination and pronation and perpendicular to the plinth,. Subject arm internally rotated by practitioner. Stationary arm of goniometer horizontal to the plinth with the pivot of the protractor on the olecranon process. Moving arm of the goniometer in line with the styloid process of the ulna.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
39 participants
Primary outcome timeframe
at 8 weeks post-op, 12 weeks post-op, 6 months post-op
Results posted on
2025-11-10
Participant Flow
Participant milestones
| Measure |
Rehabilitation and Dry Needling
Standard Rehabilitation Protocol following shoulder stabilization surgery and Dry Needling to the Shoulder girdle 1 time a week for 4 weeks between weeks 4 and 8 post operatively
Rehabilitation and Dry Needling: Subjects will receive post-operative rehabilitation that is the standard of care for the surgical procedure they underwent. Rehabilitation will begin within one week after surgery and will continue for the duration of their recovery; two to three treatments a week for approximately 6-9 months. Subjects in this group will also receive dry needling as an adjunct intervention. Dry needling treatment will be performed one time a week for four weeks and will begin four weeks post-operative.
|
Rehabilitation
Standard Rehabilitation Protocol following shoulder stabilization surgery alone
Rehabilitation: Subjects will receive post-operative rehabilitation that is the standard of care for the surgical procedure they underwent. Rehabilitation will begin within one week after surgery and will continue for the duration of their recovery; two to three treatments a week for approximately 6-9 months.
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
20
|
|
Overall Study
COMPLETED
|
17
|
19
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Rehabilitation and Dry Needling
n=19 Participants
Standard Rehabilitation Protocol following shoulder stabilization surgery and Dry Needling to the Shoulder girdle 1 time a week for 4 weeks between weeks 4 and 8 post operatively
Rehabilitation and Dry Needling: Subjects will receive post-operative rehabilitation that is the standard of care for the surgical procedure they underwent. Rehabilitation will begin within one week after surgery and will continue for the duration of their recovery; two to three treatments a week for approximately 6-9 months. Subjects in this group will also receive dry needling as an adjunct intervention. Dry needling treatment will be performed one time a week for four weeks and will begin four weeks post-operative.
|
Rehabilitation
n=20 Participants
Standard Rehabilitation Protocol following shoulder stabilization surgery alone
Rehabilitation: Subjects will receive post-operative rehabilitation that is the standard of care for the surgical procedure they underwent. Rehabilitation will begin within one week after surgery and will continue for the duration of their recovery; two to three treatments a week for approximately 6-9 months.
|
Total
n=39 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Continuous
|
19.9 years
STANDARD_DEVIATION 1.1 • n=19 Participants
|
21.6 years
STANDARD_DEVIATION 4.5 • n=20 Participants
|
20.78 years
STANDARD_DEVIATION 3.33 • n=39 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=19 Participants
|
3 Participants
n=20 Participants
|
6 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=19 Participants
|
17 Participants
n=20 Participants
|
33 Participants
n=39 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
19 Participants
n=19 Participants
|
20 Participants
n=20 Participants
|
39 Participants
n=39 Participants
|
|
Numeric Pain Rating Scale (NPRS)
|
2.21 units on a scale
STANDARD_DEVIATION 1.8 • n=19 Participants
|
2.55 units on a scale
STANDARD_DEVIATION 1.8 • n=20 Participants
|
2.38 units on a scale
STANDARD_DEVIATION 1.8 • n=39 Participants
|
|
Shoulder Flexion Passive Range of Motion (PROM)
|
134.2 degrees
STANDARD_DEVIATION 15.1 • n=19 Participants
|
128 degrees
STANDARD_DEVIATION 14.5 • n=20 Participants
|
131.1 degrees
STANDARD_DEVIATION 14.7 • n=39 Participants
|
|
Shoulder External Rotation (ER) PROM
|
30 degrees
STANDARD_DEVIATION 15.9 • n=19 Participants
|
28.67 degrees
STANDARD_DEVIATION 21.4 • n=20 Participants
|
29.34 degrees
STANDARD_DEVIATION 18.7 • n=39 Participants
|
|
Shoulder Internal Rotation (IR) PROM
|
44.5 degrees
STANDARD_DEVIATION 12.6 • n=19 Participants
|
36.8 degrees
STANDARD_DEVIATION 17.9 • n=20 Participants
|
40.1 degrees
STANDARD_DEVIATION 15.6 • n=39 Participants
|
|
Global Rating of Change (GROC)
|
4.5 units on a scale
STANDARD_DEVIATION 2 • n=19 Participants
|
4.8 units on a scale
STANDARD_DEVIATION 2 • n=20 Participants
|
4.6 units on a scale
STANDARD_DEVIATION 2 • n=39 Participants
|
|
Shoulder Pain and Disability Index (SPADI)
|
42.8 units on a scale
STANDARD_DEVIATION 21.9 • n=19 Participants
|
41.4 units on a scale
STANDARD_DEVIATION 17 • n=20 Participants
|
42 units on a scale
STANDARD_DEVIATION 18.4 • n=39 Participants
|
|
Patient Specific Functional Scale (PSFS)
|
2.9 units on a scale
STANDARD_DEVIATION 2.2 • n=19 Participants
|
3.5 units on a scale
STANDARD_DEVIATION 2.1 • n=20 Participants
|
3.2 units on a scale
STANDARD_DEVIATION 2.2 • n=39 Participants
|
PRIMARY outcome
Timeframe: at 8 weeks post-op, 12 weeks post-op, 6 months post-opPopulation: 3 subjects lost to follow-up between 8 weeks and 6 months. Rows are indicative of multiple timepoints of data collection.
Subject is supine with hips and knees flexed for stabilization. Elbow will be extended, forearm relaxed, and wrist in neutral position. Subjects' arm will be raised into forward flexion by the practitioner. The stationary arm of the goniometer will be placed parallel to the spine but at the lateral aspect of the body. The moving arm of the goniometer will be placed along the midline of the humerus.
Outcome measures
| Measure |
Rehabilitation and Dry Needling
n=19 Participants
Standard Rehabilitation Protocol following shoulder stabilization surgery and Dry Needling to the Shoulder girdle 1 time a week for 4 weeks between weeks 4 and 8 post operatively
Rehabilitation and Dry Needling: Subjects will receive post-operative rehabilitation that is the standard of care for the surgical procedure they underwent. Rehabilitation will begin within one week after surgery and will continue for the duration of their recovery; two to three treatments a week for approximately 6-9 months. Subjects in this group will also receive dry needling as an adjunct intervention. Dry needling treatment will be performed one time a week for four weeks and will begin four weeks post-operative.
|
Rehabilitation
n=20 Participants
Standard Rehabilitation Protocol following shoulder stabilization surgery alone
Rehabilitation: Subjects will receive post-operative rehabilitation that is the standard of care for the surgical procedure they underwent. Rehabilitation will begin within one week after surgery and will continue for the duration of their recovery; two to three treatments a week for approximately 6-9 months.
|
|---|---|---|
|
Shoulder Flexion Passive Range of Movement (PROM)
8 weeks post-op
|
153.9 degrees
Standard Deviation 12.40
|
153.2 degrees
Standard Deviation 15.60
|
|
Shoulder Flexion Passive Range of Movement (PROM)
12 weeks post-op
|
164.5 degrees
Standard Deviation 12.70
|
165.2 degrees
Standard Deviation 12.30
|
|
Shoulder Flexion Passive Range of Movement (PROM)
6 months post-op
|
171.02 degrees
Standard Deviation 11.49
|
178.7 degrees
Standard Deviation 4.66
|
PRIMARY outcome
Timeframe: at 8 weeks post-op, 12 weeks post-op, 6 months post-opPopulation: 3 subjects lost to follow-up between 8 weeks and 6 months. Rows are indicative of multiple timepoints of data collection.
Subject is supine on the plinth with hips and knees flexed for stabilization. Tested arm abducted to 90 degrees. Elbow flexed to 90 degrees. Forearm in the midposition between supination and pronation and perpendicular to the plinth. Subject arm rotated by the practitioner. The stationary arm of the goniometer will be horizontal to the plinth with the pivot of the protractor on the olecranon process. The moving arm of the goniometer is in line with the styloid process of the ulna.
Outcome measures
| Measure |
Rehabilitation and Dry Needling
n=19 Participants
Standard Rehabilitation Protocol following shoulder stabilization surgery and Dry Needling to the Shoulder girdle 1 time a week for 4 weeks between weeks 4 and 8 post operatively
Rehabilitation and Dry Needling: Subjects will receive post-operative rehabilitation that is the standard of care for the surgical procedure they underwent. Rehabilitation will begin within one week after surgery and will continue for the duration of their recovery; two to three treatments a week for approximately 6-9 months. Subjects in this group will also receive dry needling as an adjunct intervention. Dry needling treatment will be performed one time a week for four weeks and will begin four weeks post-operative.
|
Rehabilitation
n=20 Participants
Standard Rehabilitation Protocol following shoulder stabilization surgery alone
Rehabilitation: Subjects will receive post-operative rehabilitation that is the standard of care for the surgical procedure they underwent. Rehabilitation will begin within one week after surgery and will continue for the duration of their recovery; two to three treatments a week for approximately 6-9 months.
|
|---|---|---|
|
Shoulder External Rotation PROM at 8 Weeks
6 months post-op
|
77.97 degrees
Standard Deviation 16.32
|
82.13 degrees
Standard Deviation 12.21
|
|
Shoulder External Rotation PROM at 8 Weeks
8 weeks post-op
|
50.05 degrees
Standard Deviation 17.00
|
51.50 degrees
Standard Deviation 18.8
|
|
Shoulder External Rotation PROM at 8 Weeks
12 weeks post-op
|
64.4 degrees
Standard Deviation 14.30
|
66.0 degrees
Standard Deviation 13.8
|
PRIMARY outcome
Timeframe: at 8 weeks post-op, 12 weeks post-op, 6 months post-opPopulation: 3 subjects lost to follow-up between 8 weeks and 6 months. Rows are indicative of multiple timepoints of data collection.
Subject is supine on the plinth with hips and knees flexed for stabilization. Tested arm abducted to 90 degrees, elbow flexed to 90 degrees, forearm in the midposition between supination and pronation and perpendicular to the plinth,. Subject arm internally rotated by practitioner. Stationary arm of goniometer horizontal to the plinth with the pivot of the protractor on the olecranon process. Moving arm of the goniometer in line with the styloid process of the ulna.
Outcome measures
| Measure |
Rehabilitation and Dry Needling
n=19 Participants
Standard Rehabilitation Protocol following shoulder stabilization surgery and Dry Needling to the Shoulder girdle 1 time a week for 4 weeks between weeks 4 and 8 post operatively
Rehabilitation and Dry Needling: Subjects will receive post-operative rehabilitation that is the standard of care for the surgical procedure they underwent. Rehabilitation will begin within one week after surgery and will continue for the duration of their recovery; two to three treatments a week for approximately 6-9 months. Subjects in this group will also receive dry needling as an adjunct intervention. Dry needling treatment will be performed one time a week for four weeks and will begin four weeks post-operative.
|
Rehabilitation
n=20 Participants
Standard Rehabilitation Protocol following shoulder stabilization surgery alone
Rehabilitation: Subjects will receive post-operative rehabilitation that is the standard of care for the surgical procedure they underwent. Rehabilitation will begin within one week after surgery and will continue for the duration of their recovery; two to three treatments a week for approximately 6-9 months.
|
|---|---|---|
|
Shoulder Internal Rotation (IR) PROM
8 weeks post-op
|
57.3 degrees
Standard Deviation 11.36
|
55 degrees
Standard Deviation 15.44
|
|
Shoulder Internal Rotation (IR) PROM
12 weeks post-op
|
68.9 degrees
Standard Deviation 10.3
|
63.8 degrees
Standard Deviation 9.6
|
|
Shoulder Internal Rotation (IR) PROM
6 months post-op
|
71.92 degrees
Standard Deviation 10.29
|
66.13 degrees
Standard Deviation 12.64
|
PRIMARY outcome
Timeframe: at 8 weeks post-op, 12 weeks post-op, 6 months post-opPopulation: 3 subjects lost to follow-up between 8 weeks and 6 months. Rows are indicative of multiple timepoints of data collection.
Numeric Pain Rating Scale. Numerical Scale from 1-10. Subjects are asked self-report pain on a scale from 1 - 10, 1 being the least amount of pain and 10 being the most. The Minimum Important Difference for the NPRS (on a scale from 0-10) range from -1.5 (small change) to -3.0 (medium change) to -3.5 (large change)
Outcome measures
| Measure |
Rehabilitation and Dry Needling
n=19 Participants
Standard Rehabilitation Protocol following shoulder stabilization surgery and Dry Needling to the Shoulder girdle 1 time a week for 4 weeks between weeks 4 and 8 post operatively
Rehabilitation and Dry Needling: Subjects will receive post-operative rehabilitation that is the standard of care for the surgical procedure they underwent. Rehabilitation will begin within one week after surgery and will continue for the duration of their recovery; two to three treatments a week for approximately 6-9 months. Subjects in this group will also receive dry needling as an adjunct intervention. Dry needling treatment will be performed one time a week for four weeks and will begin four weeks post-operative.
|
Rehabilitation
n=20 Participants
Standard Rehabilitation Protocol following shoulder stabilization surgery alone
Rehabilitation: Subjects will receive post-operative rehabilitation that is the standard of care for the surgical procedure they underwent. Rehabilitation will begin within one week after surgery and will continue for the duration of their recovery; two to three treatments a week for approximately 6-9 months.
|
|---|---|---|
|
Numeric Pain Rating Scale (NPRS)
8 weeks post-op
|
2.2 units on a scale
Standard Deviation 1.71
|
1.8 units on a scale
Standard Deviation 1.87
|
|
Numeric Pain Rating Scale (NPRS)
12 weeks post-op
|
1.07 units on a scale
Standard Deviation 1.54
|
1.45 units on a scale
Standard Deviation 2.04
|
|
Numeric Pain Rating Scale (NPRS)
6 months post-op
|
1.52 units on a scale
Standard Deviation 2.17
|
0.90 units on a scale
Standard Deviation 1.65
|
SECONDARY outcome
Timeframe: at 8 weeks post-op, 12 weeks post-op, 6 months post-opPopulation: 3 subjects lost to follow-up between 8 weeks and 6 months. Rows are indicative of multiple timepoints of data collection.
Score is rated from -7 (very great deal worse) to +7 (very great deal better) where subjects check an answer that best describes their current perceived status since injury onset to time of follow up. Meaningful patient improvement/deterioration (on a 15 point scale) is considered to be \>5 or \<-5.
Outcome measures
| Measure |
Rehabilitation and Dry Needling
n=19 Participants
Standard Rehabilitation Protocol following shoulder stabilization surgery and Dry Needling to the Shoulder girdle 1 time a week for 4 weeks between weeks 4 and 8 post operatively
Rehabilitation and Dry Needling: Subjects will receive post-operative rehabilitation that is the standard of care for the surgical procedure they underwent. Rehabilitation will begin within one week after surgery and will continue for the duration of their recovery; two to three treatments a week for approximately 6-9 months. Subjects in this group will also receive dry needling as an adjunct intervention. Dry needling treatment will be performed one time a week for four weeks and will begin four weeks post-operative.
|
Rehabilitation
n=20 Participants
Standard Rehabilitation Protocol following shoulder stabilization surgery alone
Rehabilitation: Subjects will receive post-operative rehabilitation that is the standard of care for the surgical procedure they underwent. Rehabilitation will begin within one week after surgery and will continue for the duration of their recovery; two to three treatments a week for approximately 6-9 months.
|
|---|---|---|
|
Global Rating of Change
8 weeks post-op
|
5.32 units on a scale
Standard Deviation 1.29
|
5.50 units on a scale
Standard Deviation 1.53
|
|
Global Rating of Change
12 weeks post-op
|
5.58 units on a scale
Standard Deviation 2.14
|
5.95 units on a scale
Standard Deviation 1.09
|
|
Global Rating of Change
6 months post-op
|
5.48 units on a scale
Standard Deviation 2.72
|
6.6 units on a scale
Standard Deviation 0.60
|
SECONDARY outcome
Timeframe: at 8 weeks post-op, 12 weeks post-op, 6 months post-opPopulation: 3 subjects lost to follow-up between 8 weeks and 6 months. Rows are indicative of multiple timepoints of data collection.
The PSFS is a self-report questionnaire assessing pain, instability and activities of daily living (ADLs). The Minimum Important Difference for the PSFS (on a scale from 0-10) range from 1.3 (small change) to 2.3 (medium change) to 2.7 (large change). The total score is reported.
Outcome measures
| Measure |
Rehabilitation and Dry Needling
n=19 Participants
Standard Rehabilitation Protocol following shoulder stabilization surgery and Dry Needling to the Shoulder girdle 1 time a week for 4 weeks between weeks 4 and 8 post operatively
Rehabilitation and Dry Needling: Subjects will receive post-operative rehabilitation that is the standard of care for the surgical procedure they underwent. Rehabilitation will begin within one week after surgery and will continue for the duration of their recovery; two to three treatments a week for approximately 6-9 months. Subjects in this group will also receive dry needling as an adjunct intervention. Dry needling treatment will be performed one time a week for four weeks and will begin four weeks post-operative.
|
Rehabilitation
n=20 Participants
Standard Rehabilitation Protocol following shoulder stabilization surgery alone
Rehabilitation: Subjects will receive post-operative rehabilitation that is the standard of care for the surgical procedure they underwent. Rehabilitation will begin within one week after surgery and will continue for the duration of their recovery; two to three treatments a week for approximately 6-9 months.
|
|---|---|---|
|
Patient Specific Functional Scale
8 weeks post-op
|
5.78 units on a scale
Standard Deviation 2.69
|
6.47 units on a scale
Standard Deviation 2.69
|
|
Patient Specific Functional Scale
12 weeks post-op
|
6.91 units on a scale
Standard Deviation 2.71
|
7.79 units on a scale
Standard Deviation 2.42
|
|
Patient Specific Functional Scale
6 months post-op
|
8.63 units on a scale
Standard Deviation 2.09
|
9.21 units on a scale
Standard Deviation 1.66
|
SECONDARY outcome
Timeframe: at 8 weeks post-op, 12 weeks post-op, 6 months post-opPopulation: 3 subjects lost to follow-up between 8 weeks and 6 months. Rows are indicative of multiple timepoints of data collection.
The SPADI is a self-report questionnaire assessing pain and disability. The Minimum Important Difference for the SPADI (on a 100- point scale) is 13.2. The total score is reported. Minimum score is 0.
Outcome measures
| Measure |
Rehabilitation and Dry Needling
n=19 Participants
Standard Rehabilitation Protocol following shoulder stabilization surgery and Dry Needling to the Shoulder girdle 1 time a week for 4 weeks between weeks 4 and 8 post operatively
Rehabilitation and Dry Needling: Subjects will receive post-operative rehabilitation that is the standard of care for the surgical procedure they underwent. Rehabilitation will begin within one week after surgery and will continue for the duration of their recovery; two to three treatments a week for approximately 6-9 months. Subjects in this group will also receive dry needling as an adjunct intervention. Dry needling treatment will be performed one time a week for four weeks and will begin four weeks post-operative.
|
Rehabilitation
n=20 Participants
Standard Rehabilitation Protocol following shoulder stabilization surgery alone
Rehabilitation: Subjects will receive post-operative rehabilitation that is the standard of care for the surgical procedure they underwent. Rehabilitation will begin within one week after surgery and will continue for the duration of their recovery; two to three treatments a week for approximately 6-9 months.
|
|---|---|---|
|
Shoulder Pain and Disability Index Functional Outcome Measure
6 months post-op
|
6.29 units on a scale
Standard Deviation 9.83
|
1.96 units on a scale
Standard Deviation 1.83
|
|
Shoulder Pain and Disability Index Functional Outcome Measure
8 weeks post-op
|
19.3 units on a scale
Standard Deviation 16.92
|
18.1 units on a scale
Standard Deviation 13.79
|
|
Shoulder Pain and Disability Index Functional Outcome Measure
12 weeks post-op
|
10.87 units on a scale
Standard Deviation 13.00
|
8.0 units on a scale
Standard Deviation 7.01
|
Adverse Events
Rehabilitation and Dry Needling
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Rehabilitation
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place