Dry Needling for Shoulder Adhesive Capsulitis

NCT03861923 | Terminated

• 1 other identifier: PRO00101726
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the addition of dry needling to exercise as part of physical therapy for the treatment of shoulder adhesive capsulitis. There will be two groups. One will receive actual dry needling to the clinically determined shoulder / parascapular trigger points. The other group will receive a sham needle treatment to the clinically determined areas.

Conditions

Shoulder Adhesive Capsulitis; Shoulder Pain; Frozen Shoulder

Keywords

dry needling; physical therapy; trigger point

Outcome Measures

Primary Outcomes (1)

• Shoulder Pain and Disability Index Change

  The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire. Two dimensions are measured, one for pain and the other for functional activities. The pain dimension includes five questions to determine the severity of an individual's pain. The functional activities are assessed with eight questions. The two dimensions are combined into one score. Scores range from 0 to 100 with scores closer to 0 indicating lower (or no) disability and scores closer to 100 indicating greater disability. It takes 5 to 10 minutes for a patient to complete.

  1-week, 1-month, 6-months

Secondary Outcomes (1)

• Numeric Pain Rating Scale Change

  1-week, 1-month, 6- months

Study Arms (2)

Dry needling and exercise

EXPERIMENTAL

Other: Dry needling; Other: Therapeutic Exercise

Sham dry needling and exercise

SHAM COMPARATOR

Other: Sham Dry Needling; Other: Therapeutic Exercise

Interventions

Dry needling OTHER

Trigger point dry needling to trigger points in the shoulder or parascapular muscles using monofilament needle (i.e., acupuncture needle). Clean needle approach using sterile needles.

Also known as: Trigger Point Dry Needling

Dry needling and exercise

Sham Dry Needling OTHER

Sham needle approach using a finishing nail in a tube sheath. The finishing nail will be placed over the trigger point so that the patient perceives a sharp sensation. The tube (not the nail) will be moved up and down to mimic the action of needling.

Sham dry needling and exercise

Therapeutic Exercise OTHER

Exercise including flexibility, range of motion, strengthening will be provided by the treating physical therapist based on the impairments identified.

Also known as: Exercise

Dry needling and exercise; Sham dry needling and exercise

Eligibility Criteria

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

You may qualify if:

• Primary complaint of shoulder pain and stiffness
• Gradual onset of symptoms
• Glenohumeral passive range of motion limited in multiple directions
• Glenohumeral passive range of motion decreases as the humerus is abducted from 45 degrees to 90 degrees
• Age 18 to 65 years
• Reports pain with normal activity greater than or equal to 2/10 on the numeric pain rating scale
• Read and speak English

You may not qualify if:

• Signs or symptoms of cervical radiculopathy, radiculitis, or referral from the cervical spine
• Clinical evidence as determined in the examination of an alternative shoulder diagnosis
• Normal passive shoulder range of motion
• Known radiographic evidence of glenohumeral osteoarthritis
• Known neurologic disease
• Received dry needling or acupuncture within the past 6 months
• Fear of needling
• Currently being treated with anticoagulant medication
• Shoulder pain and disability index (SPADI) score less than 10% or greater than 90%

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke Sports Science Institute

Durham, North Carolina, 27710, United States

Location

Related Publications (9)

• Clewley D, Flynn TW, Koppenhaver S. Trigger point dry needling as an adjunct treatment for a patient with adhesive capsulitis of the shoulder. J Orthop Sports Phys Ther. 2014 Feb;44(2):92-101. doi: 10.2519/jospt.2014.4915. Epub 2013 Nov 21.

  PMID: 24261931 BACKGROUND

• Dempsey AL, Mills T, Karsch RM, Branch TP. Maximizing total end range time is safe and effective for the conservative treatment of frozen shoulder patients. Am J Phys Med Rehabil. 2011 Sep;90(9):738-45. doi: 10.1097/PHM.0b013e318214ed0d.

  PMID: 21430510 BACKGROUND

• Griggs SM, Ahn A, Green A. Idiopathic adhesive capsulitis. A prospective functional outcome study of nonoperative treatment. J Bone Joint Surg Am. 2000 Oct;82(10):1398-407.

  PMID: 11057467 BACKGROUND

• Hall ML, Mackie AC, Ribeiro DC. Effects of dry needling trigger point therapy in the shoulder region on patients with upper extremity pain and dysfunction: a systematic review with meta-analysis. Physiotherapy. 2018 Jun;104(2):167-177. doi: 10.1016/j.physio.2017.08.001. Epub 2017 Aug 7.

  PMID: 29439829 BACKGROUND

• Jewell DV, Riddle DL, Thacker LR. Interventions associated with an increased or decreased likelihood of pain reduction and improved function in patients with adhesive capsulitis: a retrospective cohort study. Phys Ther. 2009 May;89(5):419-29. doi: 10.2522/ptj.20080250. Epub 2009 Mar 6.

  PMID: 19270045 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

• 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

• Tejera-Falcon E, Toledo-Martel NDC, Sosa-Medina FM, Santana-Gonzalez F, Quintana-de la Fe MDP, Gallego-Izquierdo T, Pecos-Martin D. Dry needling in a manual physiotherapy and therapeutic exercise protocol for patients with chronic mechanical shoulder pain of unspecific origin: a protocol for a randomized control trial. BMC Musculoskelet Disord. 2017 Sep 18;18(1):400. doi: 10.1186/s12891-017-1746-3.

  PMID: 28923050 BACKGROUND

• Sutlive TG, Golden A, King K, Morris WB, Morrison JE, Moore JH, Koppenhaver S. SHORT-TERM EFFECTS OF TRIGGER POINT DRY NEEDLING ON PAIN AND DISABILITY IN SUBJECTS WITH PATELLOFEMORAL PAIN SYNDROME. Int J Sports Phys Ther. 2018 Jun;13(3):462-473.

  PMID: 30038832 BACKGROUND

MeSH Terms

Conditions

Bursitis; Shoulder Pain

Interventions

Dry Needling; Exercise Therapy; Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Derek Clewley, DPT, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2019
• First Posted: March 4, 2019
• Study Start: October 13, 2020
• Primary Completion: January 18, 2024
• Study Completion: January 18, 2024
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)