Dry Needling for Sub Acromial Pain Syndrome

NCT03442894 | Completed

• 1 other identifier: FWH20170083H
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Shoulder pain; Subacromial; bursitis; rotator cuff; tendinopathy; dry needling; myofascial trigger point

Outcome Measures

Primary Outcomes (1)

• Change in Shoulder Pain and Disability Index (SPADI) scores

  The SPADI is a 100-point, 13 item self-administered questionnaire. It is divided into two subscales: a five item pain subscale and an eight-item disability subscale. Williams et al have shown that the SPADI is responsive to change and accurately discriminates between patients who are improving or worsening. Michener and Leggin also reported a high test-retest reliability and internal consistency for this instrument. When compared to the Sickness Impact Profile (SIP), Heald et al found that the construct validity of the SPADI is moderately strong and it is more responsive to change than the SIP. A recent systematic review identified a minimal detectable change (MDC) of 18 and a minimally clinically important difference (MCID) of between 8-13 points. The validity and responsiveness to change of SPADI have been described in physical therapy, as well as primary and secondary care settings.

  Baseline, 6-weeks, 6 months, 12 months

Secondary Outcomes (4)

• Patient Reported Outcomes Measurement Information Systems (Promis-29)

  Baseline, 6 weeks, 6 months, 12 months

• Patient Acceptable Symptom Scale (PASS)

  Baseline, 6 weeks, 6 months, 12 months

• Optimal Screening for Prediction of Referral and Outcome Yellow Flags assessment tool (OSPRO-YF)

  Baseline, 6 weeks, 6 months, 12 months

• Healthcare Utilization

  12 months following enrollment

Study Arms (3)

Standard PT Treatment

ACTIVE COMPARATOR

This group will receive manual therapy and exercise interventions provided by their physical therapist. The treatment will occur for 10 sessions over 6 weeks. Interventions: Manual therapy interventions including mobilization and manipulation of the shoulder girdle spine and ribcage. Exercise interventions will include strengthening and flexibility exercises for rotator cuff and shoulder girdle musculature.

Procedure: Standard Physical Therapy Treatment

Standard PT Treatment plus DN

EXPERIMENTAL

In addition to the standard PT interventions, the Dry Needling (DN) group will receive 6 DN sessions as part of their rehabilitation visits.

Procedure: Standard Physical Therapy Treatment; Procedure: Dry Needling

Standard PT Treatment plus Sham DN

SHAM COMPARATOR

In addition to the standard PT treatment, patients in the sham DN group will receive 6 sessions of sham DN intervention.

Procedure: Standard Physical Therapy Treatment; Procedure: Sham Dry Needling

Interventions

Standard Physical Therapy Treatment PROCEDURE

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.

Standard PT Treatment; Standard PT Treatment plus DN; Standard PT Treatment plus Sham DN

Dry Needling PROCEDURE

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.

Standard PT Treatment plus DN

Sham Dry Needling PROCEDURE

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.

Standard PT Treatment plus Sham DN

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 to 65
• Read and speak English well enough to provide informed consent, follow study instructions, and independently answer the questionnaires/surveys
• Tricare beneficiary
• Primary complaint of new episode of shoulder pain; defined as not having sought care for shoulder condition in 6 months prior
• Available and willing to come in for treatment (\~10 sessions over 6 week period)
• Meets criteria for SAPS from description below, by having 2 of the 4 following physical exam findings:
• Impingement signs (Neer, Hawkins, or Jobe tests)
• Painful arc
• Pain with isometric resistance (ER/IR/ABD)
• Rotator cuff weakness on the injured side in comparison to the opposite side

You may not qualify if:

• History of shoulder dislocation, subluxation, fracture, adhesive capsulitis of the glenohumeral joint, or cervical/shoulder/upper back surgery
• Presence of cervical radiculopathy, radiculitis, or referral from cervical spine
• Total baseline SPADI score less than 20% (to prevent a ceiling effect with treatment)
• Anyone pending a medical evaluation board, discharge from the military for medical reasons, or pending or undergoing any litigation for an injury
• Unable to give informed consent to participate in the study.
• Pregnancy

Sponsors & Collaborators

• 59th Medical Wing: lead

Study Sites (1)

Wilford Hall Ambulatory Surgical Center

San Antonio, Texas, 78236, United States

Location

Related Publications (5)

• Rhon DI, Boyles RB, Cleland JA. One-year outcome of subacromial corticosteroid injection compared with manual physical therapy for the management of the unilateral shoulder impingement syndrome: a pragmatic randomized trial. Ann Intern Med. 2014 Aug 5;161(3):161-9. doi: 10.7326/M13-2199.

  PMID: 25089860 BACKGROUND

• Pope DP, Croft PR, Pritchard CM, Silman AJ. Prevalence of shoulder pain in the community: the influence of case definition. Ann Rheum Dis. 1997 May;56(5):308-12. doi: 10.1136/ard.56.5.308.

  PMID: 9175931 BACKGROUND

• Perez-Palomares S, Olivan-Blazquez B, Perez-Palomares A, Gaspar-Calvo E, Perez-Benito M, Lopez-Lapena E, de la Torre-Beldarrain ML, Magallon-Botaya R. Contribution of Dry Needling to Individualized Physical Therapy Treatment of Shoulder Pain: A Randomized Clinical Trial. J Orthop Sports Phys Ther. 2017 Jan;47(1):11-20. doi: 10.2519/jospt.2017.6698. Epub 2016 Dec 10.

  PMID: 27937046 BACKGROUND

• Koppenhaver S, Embry R, Ciccarello J, Waltrip J, Pike R, Walker M, Fernandez-de-Las-Penas C, Croy T, Flynn T. Effects of dry needling to the symptomatic versus control shoulder in patients with unilateral subacromial pain syndrome. Man Ther. 2016 Dec;26:62-69. doi: 10.1016/j.math.2016.07.009. Epub 2016 Jul 21.

  PMID: 27497188 BACKGROUND

• Hando BR, Rhon DI, Cleland JA, Snodgrass SJ. Dry needling in addition to standard physical therapy treatment for sub-acromial pain syndrome: a randomized controlled trial protocol. Braz J Phys Ther. 2019 Jul-Aug;23(4):355-363. doi: 10.1016/j.bjpt.2018.10.010. Epub 2018 Nov 6.

  PMID: 30455091 DERIVED

MeSH Terms

Conditions

Shoulder Impingement Syndrome; Shoulder Pain; Bursitis; Tendinopathy

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Wounds and Injuries; Arthralgia; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Tendon Injuries

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities

Study Officials

• Ben Hando, DScPT

  US Air Force

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Subjects in the dry needling and sham dry needling groups will be masked (blinded) to whether or not they are receiving the sham or actual dry needling.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopedic and Rehabilitation Flight Commander

Model Details: 3 groups: Standard physical therapy treatment (SPT), SPT plus dry needling and SPT plus sham dry needling

Study Record Dates

• First Submitted: February 16, 2018
• First Posted: February 22, 2018
• Study Start: March 6, 2018
• Primary Completion: August 20, 2022
• Study Completion: August 20, 2022
• Last Updated: July 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)