Dry Needling for Sub Acromial Pain Syndrome
NCT03442894 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 121
Last updated 2025-07-24
Summary
This trial will investigate the benefit of trigger point dry needling (DN) for individuals with a common cause of shoulder pain - sub-acromial pain syndrome. Sub-acromial pain syndrome, also knowns as SAPS, is one of the most common causes of shoulder pain. Physical therapy treatments are routinely used for treating SAPS. One treatment approach that has been shown to be beneficial is a combination of exercises and manual or manipulative therapy. This approach has been shown to reduce pain and improve overall shoulder function in individuals with SAPS.
Recently, a novel treatment approach for SAPS has emerged that involves trigger point DN to muscles of the shoulder and ribcage. Some studies have shown promising results for this approach while others have not found it to be helpful. Overall there is currently little research available on the benefit of trigger point DN for individuals with SAPS.
This study will investigate whether adding trigger point DN to a treatment program of exercise and manual therapy provides any benefit to individuals with SAPS. To answer this question, this study will divide subjects into three groups. One group will receive just exercise and manual therapy; one group will receive manual therapy and exercise plus trigger point DN and one group will receive manual therapy and exercise plus a sham trigger point DN treatment.
All patients receiving treatment in the study will attend 10 visits to a physical therapy clinic over a 6-week period. Subjects in the dry needling and sham dry needling groups will receive 6 sessions of this treatment in addition to their 10 sessions of exercise and manual therapy.
The investigators will assess the effectiveness of the three treatment protocols by measuring patients pain, shoulder function and disability levels. These outcomes will be assessed at baseline, six weeks, 6 months and one year from enrolling in the study.
In addition to assessing clinical outcomes following treatment, the investigators will assess the amount of health care utilized by each participant in the year following enrollment in the study. The 3 groups will be analyzed to determine if there is a difference in the amount or type of additional healthcare utilized in the year following study enrollment. Examples of healthcare utilization include x-rays, medication and/or surgical procedures.
The investigators hypothesis is that individuals that receive actual trigger point DN in addition to manual therapy and exercise interventions will demonstrate greater improvements in pain, shoulder function and disability when compared to individuals receiving exercise and manual therapy alone or exercise and manual therapy with sham needling. The investigators think these differences in clinical outcomes will be present at each of the follow-up points. Additionally, the investigators hypothesize that individuals receiving actual DN will use less healthcare than those in the other two groups.
Conditions
- Subacromial Impingement Syndrome
Interventions
- PROCEDURE
-
Standard Physical Therapy Treatment
All three groups will receive manual therapy and exercise interventions provided by their physical therapist. The exact dosage and choice of exercise and manual therapy techniques will not controlled in the study. Documentation of dosage and utilization rates of each will be captured for each patient session in order to determine if these variables influence outcomes. A full shoulder exam will be conducted per standard of care at this time as well. Manual therapy and exercise interventions will be selected to address impairments uncovered in the shoulder exam.
- PROCEDURE
-
Dry Needling
In addition to the standard PT interventions, the Dry Needling (DN) group will receive 6 DN sessions as part of their rehabilitation visits (they will occur at the same time). In 6 of the scheduled 10 visits, dry-needling intervention will be performed. They will have one DN session per week, which is consistent with typical clinical practice. After they complete their standard PT treatment, and while still in the clinic, the rotator cuff and periscapular muscles will be evaluated for the presence of MTrPs. Once located, the MTrPs will be treated with DN technique, as this is consistent with routine clinical practice. Potential muscles to receive TPDN treatment include the following: suprapsinatus, teres minor, infraspinatus, deltoid, upper trapezius, middle trapezius, levator scapula, pec major and pec minor.
- PROCEDURE
-
Sham Dry Needling
In addition to the standard PT treatment, patients in the sham DN group will receive what appears to be a DN treatment, but it will not be done with the acupuncture needles and the skin will not be punctured. The Sham DN procedure will be performed over the site of identified MTrPs using a guide tube and a toothpick. A guide tube is positioned firmly over the area to be treated and a toothpick is inserted in the guide tube. The clinician taps the toothpick to mimic the skin prick from a needle and the guide tube is removed. The clinician maintains pressure on the end of the toothpick and moves the end furthest from the skin in different directions to mimic the pistoning and changes in needle angle that occur in actual dry needling. Care will be taken to treat from 1-3 muscle groups for 5-10 seconds per MrTP identified.
Sponsors & Collaborators
-
59th Medical Wing
lead FED
Principal Investigators
-
Ben Hando, DScPT · US Air Force
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-03-06
- Primary Completion
- 2022-08-20
- Completion
- 2022-08-20
Countries
- United States
Study Locations
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