Effectiveness of Dry Needling and Physical Therapy Versus Physical Therapy Alone Following Shoulder Stabilization Repair

NCT02704975 | Completed Results

• 1 other identifier: 16-007
• Study Type: interventional
• Target: 39
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Shoulder Pain

Keywords

Dry Needling, Shoulder Stabilization

Outcome Measures

Primary Outcomes (4)

• 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)

  at 8 weeks post-op, 12 weeks post-op, 6 months post-op

Secondary Outcomes (3)

• Global Rating of Change

  at 8 weeks post-op, 12 weeks post-op, 6 months post-op

• Patient Specific Functional Scale

  at 8 weeks post-op, 12 weeks post-op, 6 months post-op

• Shoulder Pain and Disability Index Functional Outcome Measure

  at 8 weeks post-op, 12 weeks post-op, 6 months post-op

Study Arms (2)

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

Device: Rehabilitation and Dry Needling

Rehabilitation

ACTIVE COMPARATOR

Standard Rehabilitation Protocol following shoulder stabilization surgery alone

Device: Rehabilitation

Interventions

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.

Rehabilitation and Dry Needling

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.

Rehabilitation

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• yo DOD Beneficiaries
• Status Post Shoulder Stabilization Repair Surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Keller Army Community Hospital: lead

MeSH Terms

Conditions

Shoulder Pain

Interventions

Rehabilitation; Dry Needling

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Complementary Therapies; Physical Therapy Modalities

Limitations and Caveats

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.

Results Point of Contact

• Title: Rob Halle
• Organization: United States Army

robhalle@gmail.com

910-689-8887

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2016
• First Posted: March 10, 2016
• Study Start: March 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: November 10, 2025
• Results First Posted: November 10, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share