Adhesive Capsulitis: Prospective Analysis of Efficacy and Financial Impact for Use of Physical Therapy in Treatment

NCT02283996 | Recruiting Phase 4

• 1 other identifier: 2014P001688
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to identify individuals 18 or older who have diagnostic presentation of adhesive capsulitis and randomize them into two arms, distinguished by use of physical therapy and steroid injections compared with steroid injections followed by watchful waiting. This prospective study will be used to determine whether there is a significant impact on patient outcome and whether the additional financial burden is justified. There are no experimental interventions for this study. The use of physical therapy, oral and parenteral corticosteroids, and watchful waiting are offered following the standard of care for adhesive capsulitis. Our hypothesis is that patients will not have a significant difference in outcome between the two study arms. One group will undergo regular physical therapy with corticosteroid injections (Arm 1) and the other will have steroid injections during the inflammatory phase only and then be regularly observed (Arm 2). We also hypothesize there will be a significant financial burden associated with the PT arm that is not justified with the possibility of increased symptom reports in that arm.

Conditions

Adhesive Capsulitis; Frozen Shoulder; Shoulder Frozen

Keywords

Adhesive Capsulitis; Frozen Shoulder; Shoulder Frozen; Physical Therapy; Corticosteroid Injections; Hydrodilation, Hydro-dilation; Watchful Waiting; Prospective; Glenohumeral Ligament

Outcome Measures

Primary Outcomes (1)

• Functional outcome based on the American Shoulder and Elbow Surgeons Standardized Questionnaire

  At 1 year post-enrollment, patients will repeat the American Shoulder and Elbow Surgeons Standardized questionnaire. The scores range from 0-100 with categorized subsets.

  November 2014 to November 2023

Secondary Outcomes (2)

• Functional outcome based on the Disabilities of the Arm, Shoulder, and Hand (DASH) score sheet

  November 2014 to November 2023

• Functional outcome based on the Constant shoulder score sheet

  November 2014 to November 2023

Study Arms (2)

Physical Therapy with Steroid Injection

EXPERIMENTAL

Patients will undergo regular physical therapy as defined by the standard of care at Massachusetts General Hospital for Adhesive Capsulitis (Frozen Shoulder). If they are in the inflammatory phase of the condition, they will receive 40 mg of depot methylprednisolone in solution with 2 cc of 1% lidocaine.

Other: Physical Therapy; Drug: Depot Methylprednisolone

Watchful Waiting with Steroid Injection

EXPERIMENTAL

Patients will undergo no therapeutic intervention outside of steroid injection. If they are in the inflammatory phase of the condition, they will receive 40 mg of depot methylprednisolone in solution with 2 cc of 1% lidocaine.

Drug: Depot Methylprednisolone

Interventions

Physical Therapy OTHER

The following link contains the protocol for physical therapy that will be used in the study. There are no other ancillary devices or drugs used in this study aside from the depot methylprednisolone listed under interventions. Brigham and Women's/Massachusetts General Standard of Care Guidelines for Physical Therapy in Treatment of Adhesive Capsulitis: http://www.brighamandwomens.org/Patients\_Visitors/pcs/rehabilitationservices/Physical%20Therapy%20Standards%20of%20Care%20and%20Protocols/Shoulder%20-%20Adhesive%20capsulitis.pdf

Physical Therapy with Steroid Injection

Depot Methylprednisolone DRUG

40 mg of depot methylprednisolone in solution with 2 cc of 1% lidocaine

Also known as: Depo Medrol

Physical Therapy with Steroid Injection; Watchful Waiting with Steroid Injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient must be 18 years or older
• Must meet the following definition for adhesive capsulitis as defined by the American Academy of Orthopedic Surgeons: Self-limiting condition resulting from any inflammatory process about the shoulder in which capsular scar tissue is produced, resulting in pain and limited range of motion; also called frozen shoulder
• Must be amenable to randomization into either cohort

You may not qualify if:

• Non-English speaking patients
• Pregnant women (women of childbearing potential will be advised to undergo regular pregnancy testing)
• Patients who had previously undergone operative therapy for the condition

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

MGH, Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Related Publications (16)

• Andarawis-Puri N, Kuntz AF, Kim SY, Soslowsky LJ. Effect of anterior supraspinatus tendon partial-thickness tears on infraspinatus tendon strain through a range of joint rotation angles. J Shoulder Elbow Surg. 2010 Jun;19(4):617-23. doi: 10.1016/j.jse.2009.10.003. Epub 2010 Jan 15.

  PMID: 20080051 BACKGROUND

• Bal A, Eksioglu E, Gulec B, Aydog E, Gurcay E, Cakci A. Effectiveness of corticosteroid injection in adhesive capsulitis. Clin Rehabil. 2008 Jun;22(6):503-12. doi: 10.1177/0269215508086179.

  PMID: 18511530 BACKGROUND

• Buchbinder R, Youd JM, Green S, Stein A, Forbes A, Harris A, Bennell K, Bell S, Wright WJ. Efficacy and cost-effectiveness of physiotherapy following glenohumeral joint distension for adhesive capsulitis: a randomized trial. Arthritis Rheum. 2007 Aug 15;57(6):1027-37. doi: 10.1002/art.22892.

  PMID: 17665470 BACKGROUND

• De Carli A, Vadala A, Perugia D, Frate L, Iorio C, Fabbri M, Ferretti A. Shoulder adhesive capsulitis: manipulation and arthroscopic arthrolysis or intra-articular steroid injections? Int Orthop. 2012 Jan;36(1):101-6. doi: 10.1007/s00264-011-1330-7. Epub 2011 Aug 11.

  PMID: 21833684 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

• Hegedus EJ, Goode A, Campbell S, Morin A, Tamaddoni M, Moorman CT 3rd, Cook C. Physical examination tests of the shoulder: a systematic review with meta-analysis of individual tests. Br J Sports Med. 2008 Feb;42(2):80-92; discussion 92. doi: 10.1136/bjsm.2007.038406. Epub 2007 Aug 24.

  PMID: 17720798 BACKGROUND

• van den Hout WB, Vermeulen HM, Rozing PM, Vliet Vlieland TP. Impact of adhesive capsulitis and economic evaluation of high-grade and low-grade mobilisation techniques. Aust J Physiother. 2005;51(3):141-9. doi: 10.1016/s0004-9514(05)70020-9.

  PMID: 16137239 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

• Kelley MJ, McClure PW, Leggin BG. Frozen shoulder: evidence and a proposed model guiding rehabilitation. J Orthop Sports Phys Ther. 2009 Feb;39(2):135-48. doi: 10.2519/jospt.2009.2916.

  PMID: 19194024 BACKGROUND

• Lee HJ, Lim KB, Kim DY, Lee KT. Randomized controlled trial for efficacy of intra-articular injection for adhesive capsulitis: ultrasonography-guided versus blind technique. Arch Phys Med Rehabil. 2009 Dec;90(12):1997-2002. doi: 10.1016/j.apmr.2009.07.025.

  PMID: 19969160 BACKGROUND

• Maricar N, Shacklady C, McLoughlin L. Effect of Maitland mobilization and exercises for the treatment of shoulder adhesive capsulitis: a single-case design. Physiother Theory Pract. 2009 Apr;25(3):203-17. doi: 10.1080/09593980902776654.

  PMID: 19384739 BACKGROUND

• Maund E, Craig D, Suekarran S, Neilson A, Wright K, Brealey S, Dennis L, Goodchild L, Hanchard N, Rangan A, Richardson G, Robertson J, McDaid C. Management of frozen shoulder: a systematic review and cost-effectiveness analysis. Health Technol Assess. 2012;16(11):1-264. doi: 10.3310/hta16110.

  PMID: 22405512 BACKGROUND

• Michener LA, McClure PW, Sennett BJ. American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form, patient self-report section: reliability, validity, and responsiveness. J Shoulder Elbow Surg. 2002 Nov-Dec;11(6):587-94. doi: 10.1067/mse.2002.127096.

  PMID: 12469084 BACKGROUND

• Paul A, Rajkumar JS, Peter S, Lambert L. Effectiveness of sustained stretching of the inferior capsule in the management of a frozen shoulder. Clin Orthop Relat Res. 2014 Jul;472(7):2262-8. doi: 10.1007/s11999-014-3581-2. Epub 2014 Mar 25.

  PMID: 24664198 BACKGROUND

• Vastamaki H, Kettunen J, Vastamaki M. The natural history of idiopathic frozen shoulder: a 2- to 27-year followup study. Clin Orthop Relat Res. 2012 Apr;470(4):1133-43. doi: 10.1007/s11999-011-2176-4. Epub 2011 Nov 17.

  PMID: 22090356 BACKGROUND

• Waszczykowski M, Fabis J. The results of arthroscopic capsular release in the treatment of frozen shoulder - two-year follow-up. Ortop Traumatol Rehabil. 2010 May-Jun;12(3):216-24. English, Polish.

  PMID: 20675863 BACKGROUND

MeSH Terms

Conditions

Bursitis

Interventions

Physical Therapy Modalities; Methylprednisolone Acetate

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation; Methylprednisolone; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Scott D Martin, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Scott D Martin, MD

CONTACT

617-732-5329; sdmartin@partners.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Orthopedic Surgery

Study Record Dates

• First Submitted: October 31, 2014
• First Posted: November 5, 2014
• Study Start: November 1, 2014
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: October 27, 2025

Record last verified: 2025-10

Locations

US (1)