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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Rehabilitation | Active Comparator | Standard Rehabilitation Protocol following shoulder stabilization surgery alone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rehabilitation and Dry Needling | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | at 8 weeks post-op, 12 weeks post-op, 6 months post-op |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age of subjects in years. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 3 subjects lost to follow-up between 8 weeks and 6 months. Rows are indicative of multiple timepoints of data collection. | Posted | Mean | Standard Deviation | degrees | at 8 weeks post-op, 12 weeks post-op, 6 months post-op |
|
14 months
No serious adverse events were anticipated during this study; there was no all-cause mortality risk in this study. There were no adverse events reported.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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There may have been differences in manual therapy received between the two groups. The control group received additional rehab. The follow-up period was also relatively short, at 6 months. The inclusion criteria were also very specific to the subset of the population.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rob Halle | United States Army | 910-689-8887 | robhalle@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 21, 2016 | Sep 29, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020069 | Shoulder Pain |
| ID | Term |
|---|---|
| D018771 | Arthralgia |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D000079245 | Dry Needling |
| ID | Term |
|---|---|
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
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|
| Rehabilitation | Device | 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. |
|
| 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. | 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. | at 8 weeks post-op, 12 weeks post-op, 6 months post-op |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| 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) | Mean | Standard Deviation | units on a scale |
|
| Shoulder Flexion Passive Range of Motion (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. | Mean | Standard Deviation | degrees |
|
| Shoulder External Rotation (ER) 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 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. | Mean | Standard Deviation | degrees |
|
| 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. | Mean | Standard Deviation | degrees |
|
| Global Rating of Change (GROC) | 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. | Mean | Standard Deviation | units on a scale |
|
| Shoulder Pain and Disability Index (SPADI) | 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. | Mean | Standard Deviation | units on a scale |
|
| Patient Specific Functional Scale (PSFS) | 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. | Mean | Standard Deviation | units on a scale |
|
| OG001 | 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. |
|
|
| Primary | 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. | 3 subjects lost to follow-up between 8 weeks and 6 months. Rows are indicative of multiple timepoints of data collection. | Posted | Mean | Standard Deviation | degrees | at 8 weeks post-op, 12 weeks post-op, 6 months post-op |
|
|
|
| Primary | 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. | 3 subjects lost to follow-up between 8 weeks and 6 months. Rows are indicative of multiple timepoints of data collection. | Posted | Mean | Standard Deviation | degrees | at 8 weeks post-op, 12 weeks post-op, 6 months post-op |
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| Secondary | 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. | 3 subjects lost to follow-up between 8 weeks and 6 months. Rows are indicative of multiple timepoints of data collection. | Posted | Mean | Standard Deviation | units on a scale | at 8 weeks post-op, 12 weeks post-op, 6 months post-op |
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| Primary | 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) | 3 subjects lost to follow-up between 8 weeks and 6 months. Rows are indicative of multiple timepoints of data collection. | Posted | Mean | Standard Deviation | units on a scale | at 8 weeks post-op, 12 weeks post-op, 6 months post-op |
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| Secondary | 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. | 3 subjects lost to follow-up between 8 weeks and 6 months. Rows are indicative of multiple timepoints of data collection. | Posted | Mean | Standard Deviation | units on a scale | at 8 weeks post-op, 12 weeks post-op, 6 months post-op |
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| Secondary | 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. | 3 subjects lost to follow-up between 8 weeks and 6 months. Rows are indicative of multiple timepoints of data collection. | Posted | Mean | Standard Deviation | units on a scale | at 8 weeks post-op, 12 weeks post-op, 6 months post-op |
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| 0 |
| 19 |
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| 19 |
| 0 |
| 19 |
| EG001 | 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. | 0 | 20 | 0 | 20 | 0 | 20 |
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| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006296 |
| Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D000529 | Complementary Therapies |
| D026741 | Physical Therapy Modalities |
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