Shoulder PainNCT02704975
Effectiveness of Dry Needling and Physical Therapy Versus Physical Therapy Alone Following Shoulder Stabilization Repair
A study testing Rehabilitation and Dry Needling and Rehabilitation in people with Shoulder Pain, run by Keller Army Community Hospital.
Trial summary
The purpose of this single-blinded, randomized clinical trial is to determine the effectiveness of dry needling compared to a standard shoulder rehabilitation program on range of motion, functional movement, and pain in patients who have undergone shoulder stabilization surgery. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Shoulder Pain
- What is being tested?
- Rehabilitation and Dry Needling and Rehabilitation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to Dec 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18-40 yo DOD Beneficiaries
- Status Post Shoulder Stabilization Repair Surgery
Who cannot join
- Self-Reported Pregnancy
- History of blood borne pathogens/infectious disease/active infection/metal allergy
- Bleeding disorders or currently taking anti-coagulant medications
- Participants who are not fluent in English
About this study
Official title: Effectiveness of Trigger Point Dry Needling and Physical Therapy Versus Physical Therapy Alone Following Shoulder Stabilization Repair: A Randomized Controlled Trial
The purpose of this single-blinded, randomized clinical trial is to determine the effectiveness of dry needling compared to a standard shoulder rehabilitation program on range of motion, functional movement, and pain in patients who have undergone shoulder stabilization surgery. Measurements of the aforementioned dependent variables will be taken at time intervals of four weeks, eight weeks, 12 weeks, and six months post-operatively. It is hypothesized that the inclusion of dry needling will result in an increase in range of motion, increase in functional movement, and decrease in pain at an accelerated rate when compared to rehabilitation alone.
Read the detailed description
Methodology /Technical Approach 30-50 subjects at least four weeks after shoulder stabilization surgery will be randomized into two groups (one experimental group and one control group). Subjects in the experimental group will receive Trigger Point Dry Needling (TDN) intervention with standard rehabilitation protocol (Appendix A) while subjects in the control group will receive the same standard rehabilitation protocol without TDN. The experimental group will receive trigger point dry needling one time per week for four to six weeks in addition to the standard rehabilitation protocol. The control group will receive only the standard rehabilitation protocol. Baseline measurements will be taken at approximately four weeks post operatively, and subsequent measurements will be recorded at eight weeks, 12 weeks, and six months.
All patients who have undergone a shoulder stabilization procedure will be invited to participate. Description of the study and informed consent will take place prior to randomization. Concealed randomization will take place 0-7 days post-operatively.
At 4 weeks post-operatively, the following assessment tests will be undertaken: supine shoulder flexion, supine shoulder external rotation, supine shoulder internal rotation, functional movement testing, functional outcome measures, and the numeric pain rating scale. 1,2,3 Those subjects in the 'experimental group' will receive manual palpation of all upper quarter muscles, including the cervical and thoracic spine region, to detect the presence of myofascial trigger points (TPs). Dry needling will be performed to all detected TPs by a provider trained and experienced in TDN.
In addition to the TDN intervention, the experimental group subjects will undergo a rehabilitation program in accordance with a shoulder stabilization repair protocol which is the standard of care for this surgical procedure. Per the shoulder stabilization protocol, subjects will be instructed in a home exercise plan (HEP) that will reinforce the clinical treatment, will be provided with a handout of instructions, and will be required to demonstrate all exercises correctly.
Subjects in the 'control group' will undergo a rehabilitation program as described above for the 'experimental group', except that they will not receive a TDN intervention.
Objectives:
- To determine if the addition of upper quarter TDN to a rehabilitation protocol is more effective in improving range of motion and functional movement when compared to a rehabilitation protocol alone after shoulder stabilization surgery.
- To determine if the addition of upper quarter TDN to a rehabilitation protocol is more effective in decreasing pain than a rehabilitation protocol alone after shoulder stabilization surgery.
- Conditions
- Shoulder Pain
- Being tested
- Rehabilitation and Dry Needling, Rehabilitation
- Keywords
- Dry Needling, Shoulder Stabilization
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rehabilitation and Dry NeedlingDevice
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.
RehabilitationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Rehabilitation and Dry Needling | Experimental | 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 Receives: Device: Rehabilitation and Dry Needling |
| Rehabilitation | Active comparator | Standard Rehabilitation Protocol following shoulder stabilization surgery alone Receives: Device: Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder Flexion Passive Range of Movement (PROM)
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.
Measured: at 8 weeks post-op, 12 weeks post-op, 6 months post-op
Shoulder External Rotation PROM at 8 Weeks
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.
Measured: at 8 weeks post-op, 12 weeks post-op, 6 months post-op
Shoulder Internal Rotation (IR) PROM
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.
Measured: at 8 weeks post-op, 12 weeks post-op, 6 months post-op
Numeric Pain Rating Scale (NPRS)
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)
Measured: at 8 weeks post-op, 12 weeks post-op, 6 months post-op
Secondary outcomes (3)
Global Rating of Change
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.
Measured: at 8 weeks post-op, 12 weeks post-op, 6 months post-op
Patient Specific Functional Scale
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.
Measured: at 8 weeks post-op, 12 weeks post-op, 6 months post-op
Shoulder Pain and Disability Index Functional Outcome Measure
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.
Measured: at 8 weeks post-op, 12 weeks post-op, 6 months post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Shoulder PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Keller Army Community Hospital
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02704975
- Sponsor's protocol ID
- 16-007
- Status last verified
- Oct 2025
- First submitted
- 1 Mar 2016
- Last updated
- 10 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Trigger Point Dry Needling and Physical Therapy Versus Physical Therapy Alone Following Shoulder Stabilization Repair: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02704975
- Acronym / sponsor ID
- 16-007
- Conditions
- Shoulder Pain
- Keywords
- Dry Needling, Shoulder Stabilization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Keller Army Community HospitalUS federal agency
- Study start
- Mar 2016
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 10 Mar 2016 (estimated)
- Results
- Posted 10 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this single-blinded, randomized clinical trial is to determine the effectiveness of dry needling compared to a standard shoulder rehabilitation program on range of motion, functional movement, and pain in patients who have undergone shoulder stabilization surgery. Measurements of the aforementioned dependent variables will be taken at time intervals of four weeks, eight weeks, 12 weeks, and six months post-operatively. It is hypothesized that the inclusion of dry needling will result in an increase in range of motion, increase in functional movement, and decrease in pain at an accelerated rate when compared to rehabilitation alone.
Detailed description
Methodology /Technical Approach 30-50 subjects at least four weeks after shoulder stabilization surgery will be randomized into two groups (one experimental group and one control group). Subjects in the experimental group will receive Trigger Point Dry Needling (TDN) intervention with standard rehabilitation protocol (Appendix A) while subjects in the control group will receive the same standard rehabilitation protocol without TDN. The experimental group will receive trigger point dry needling one time per week for four to six weeks in addition to the standard rehabilitation protocol. The control group will receive only the standard rehabilitation protocol. Baseline measurements will be taken at approximately four weeks post operatively, and subsequent measurements will be recorded at eight weeks, 12 weeks, and six months.
All patients who have undergone a shoulder stabilization procedure will be invited to participate. Description of the study and informed consent will take place prior to randomization. Concealed randomization will take place 0-7 days post-operatively.
At 4 weeks post-operatively, the following assessment tests will be undertaken: supine shoulder flexion, supine shoulder external rotation, supine shoulder internal rotation, functional movement testing, functional outcome measures, and the numeric pain rating scale. 1,2,3 Those subjects in the 'experimental group' will receive manual palpation of all upper quarter muscles, including the cervical and thoracic spine region, to detect the presence of myofascial trigger points (TPs). Dry needling will be performed to all detected TPs by a provider trained and experienced in TDN.
In addition to the TDN intervention, the experimental group subjects will undergo a rehabilitation program in accordance with a shoulder stabilization repair protocol which is the standard of care for this surgical procedure. Per the shoulder stabilization protocol, subjects will be instructed in a home exercise plan (HEP) that will reinforce the clinical treatment, will be provided with a handout of instructions, and will be required to demonstrate all exercises correctly.
Subjects in the 'control group' will undergo a rehabilitation program as described above for the 'experimental group', except that they will not receive a TDN intervention.
Objectives:
- To determine if the addition of upper quarter TDN to a rehabilitation protocol is more effective in improving range of motion and functional movement when compared to a rehabilitation protocol alone after shoulder stabilization surgery.
- To determine if the addition of upper quarter TDN to a rehabilitation protocol is more effective in decreasing pain than a rehabilitation protocol alone after shoulder stabilization surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rehabilitation and Dry Needling | Experimental | Device: Rehabilitation and Dry NeedlingStandard 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 | Active comparator | Device: RehabilitationStandard Rehabilitation Protocol following shoulder stabilization surgery alone |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 18-40 yo DOD Beneficiaries
- Status Post Shoulder Stabilization Repair Surgery
Key exclusion criteria (4 listed)
- Self-Reported Pregnancy
- History of blood borne pathogens/infectious disease/active infection/metal allergy
- Bleeding disorders or currently taking anti-coagulant medications
- Participants who are not fluent in English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rehabilitation and Dry NeedlingSubjects 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. | Device | Rehabilitation and Dry Needling |
| RehabilitationSubjects 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. | Device | Rehabilitation |
Primary outcome
Shoulder Flexion Passive Range of Movement (PROM)
Time frame: at 8 weeks post-op, 12 weeks post-op, 6 months post-op
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.
Shoulder External Rotation PROM at 8 Weeks
Time frame: at 8 weeks post-op, 12 weeks post-op, 6 months post-op
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.
Shoulder Internal Rotation (IR) PROM
Time frame: at 8 weeks post-op, 12 weeks post-op, 6 months post-op
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.
Numeric Pain Rating Scale (NPRS)
Time frame: at 8 weeks post-op, 12 weeks post-op, 6 months post-op
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)
3 secondary outcomes
Global Rating of Change
Time frame: at 8 weeks post-op, 12 weeks post-op, 6 months post-op
Patient Specific Functional Scale
Time frame: at 8 weeks post-op, 12 weeks post-op, 6 months post-op
Shoulder Pain and Disability Index Functional Outcome Measure
Time frame: at 8 weeks post-op, 12 weeks post-op, 6 months post-op
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Rehabilitation and Dry Needling and Rehabilitation in people with Shoulder Pain, run by Keller Army Community Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shoulder Flexion Passive Range of Movement (PROM) (time frame: at 8 weeks post-op, 12 weeks post-op, 6 months post-op). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2025.