Study Summary
This trial is testing whether physical therapy in addition to steroid injections is better than just steroid injections for treating adhesive capsulitis (aka frozen shoulder). They think there might not be a difference in outcome and that the extra physical therapy will add extra financial burden with no benefits.
Eligible Conditions
- Frozen Shoulder
- Adhesive Capsulitis
Treatment Effectiveness
Effectiveness Progress
This is further along than 93% of similar trials
Study Objectives
1 Primary · 2 Secondary · Reporting Duration: November 2014 to November 2023
November 2014 to November 2023
Elbow
Functional outcome based on the Constant shoulder score sheet
Functional outcome based on the Disabilities of the Arm, Shoulder, and Hand (DASH) score sheet
Trial Safety
Safety Progress
This is further along than 85% of similar trials
Trial Design
2 Treatment Groups
Watchful Waiting with Steroid Injection
1 of 2
Physical Therapy with Steroid Injection
1 of 2
Experimental Treatment
260 Total Participants · 2 Treatment Groups
Primary Treatment: Physical Therapy · No Placebo Group · Phase 4
Watchful Waiting with Steroid Injection
Drug
Experimental Group · 1 Intervention: Depot Methylprednisolone · Intervention Types: DrugPhysical Therapy with Steroid InjectionExperimental Group · 2 Interventions: Physical Therapy, Depot Methylprednisolone · Intervention Types: Other, Drug
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: november 2014 to november 2023
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
2,699 Previous Clinical Trials
30,842,872 Total Patients Enrolled
Scott D Martin, MDPrincipal Investigator - Massachusetts General Hospital
Cedars-Sinai Medical Center
Medical School - Northwestern University
Harvard University, Residency in Otolaryngology and Head and Neck Surgery
2 Previous Clinical Trials
390 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 3 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:An inflammatory process around the shoulder can cause pain and limited range of motion, leading to adhesive capsulitis, also called frozen shoulder.
The patient must be at least 18 years old.
Eligible for the study must be adults who are able to be randomized into one of two cohorts
The study's participants must be adults who can be randomly divided into two groups.
References
- Hegedus, E J, A Goode, S Campbell, A Morin, M Tamaddoni, C T Moorman, and C Cook. 2007. “Physical Examination Tests of the Shoulder: A Systematic Review with Meta-analysis of Individual Tests”. British Journal of Sports Medicine. BMJ. doi:10.1136/bjsm.2007.038406.
- Kelley, Martin J., Phillip W. Mcclure, and Brian G. Leggin. 2009. “Frozen Shoulder: Evidence and a Proposed Model Guiding Rehabilitation”. Journal of Orthopaedic & Sports Physical Therapy. Journal of Orthopaedic & Sports Physical Therapy (JOSPT). doi:10.2519/jospt.2009.2916.
- Lee, Hong-Jae, Kil-Byung Lim, Dug-Young Kim, and Kyung-Tae Lee. 2009. “Randomized Controlled Trial for Efficacy of Intra-articular Injection for Adhesive Capsulitis: Ultrasonography-guided Versus Blind Technique”. Archives of Physical Medicine and Rehabilitation. Elsevier BV. doi:10.1016/j.apmr.2009.07.025.
- Michener, Lori A., Philip W. McClure, and Brian J. Sennett. 2002. “American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form, Patient Self-report Section: Reliability, Validity, and Responsiveness”. Journal of Shoulder and Elbow Surgery. Elsevier BV. doi:10.1067/mse.2002.127096.
- Buchbinder, Rachelle, Joanne M. Youd, Sally Green, Alicia Stein, Andrew Forbes, Anthony Harris, Kim Bennell, Simon Bell, and Warwick J. L. Wright. 2007. “Efficacy and Cost-effectiveness of Physiotherapy Following Glenohumeral Joint Distension for Adhesive Capsulitis: A Randomized Trial”. Arthritis & Rheumatism. Wiley. doi:10.1002/art.22892.
- van den Hout, Wilbert B., Henricus M. Vermeulen, Piet M. Rozing, and Thea P.M. Vliet Vlieland. 2005. “Impact of Adhesive Capsulitis and Economic Evaluation of High-grade and Low-grade Mobilisation Techniques”. Australian Journal of Physiotherapy. Elsevier BV. doi:10.1016/s0004-9514(05)70020-9.
- Jewell, Dianne V, Daniel L Riddle, and Leroy R Thacker. 2009. “Interventions Associated with an Increased or Decreased Likelihood of Pain Reduction and Improved Function in Patients with Adhesive Capsulitis: A Retrospective Cohort Study”. Physical Therapy. Oxford University Press (OUP). doi:10.2522/ptj.20080250.
- Maund, E, D Craig, S Suekarran, AR Neilson, K Wright, S Brealey, L Dennis, et al.. 2012. “Management of Frozen Shoulder: A Systematic Review and Cost-effectiveness Analysis.”. Health Technology Assessment. National Institute for Health Research. doi:10.3310/hta16110.
- Paul, Antony, Joshua Samuel Rajkumar, Smita Peter, and Litson Lambert. 2014. “Effectiveness of Sustained Stretching of the Inferior Capsule in the Management of a Frozen Shoulder”. Clinical Orthopaedics & Related Research. Ovid Technologies (Wolters Kluwer Health). doi:10.1007/s11999-014-3581-2.
- Information/NLM/NIH, NCBI. 2017. “Gprobe”. GitHub repository. https://github.com/ncbi/gprobe.
- Snow, Martyn, Ihab Boutros, and Lennard Funk. 2009. “Posterior Arthroscopic Capsular Release in Frozen Shoulder”. Arthroscopy: The Journal of Arthroscopic & Related Surgery. Elsevier BV. doi:10.1016/j.arthro.2008.08.006.
- Andarawis-Puri, Nelly, Andrew F. Kuntz, Soung-Yon Kim, and Louis J. Soslowsky. 2010. “Effect of Anterior Supraspinatus Tendon Partial-thickness Tears on Infraspinatus Tendon Strain Through a Range of Joint Rotation Angles”. Journal of Shoulder and Elbow Surgery. Elsevier BV. doi:10.1016/j.jse.2009.10.003.
- Vastamäki, Heidi, Jyrki Kettunen, and Martti Vastamäki. 2012. “The Natural History of Idiopathic Frozen Shoulder: A 2- to 27-year Followup Study”. Clinical Orthopaedics & Related Research. Ovid Technologies (Wolters Kluwer Health). doi:10.1007/s11999-011-2176-4.
- Bal, Ajda, Emel Eksioglu, Berna Gulec, Ece Aydog, Eda Gurcay, and Aytul Cakci. 2008. “Effectiveness of Corticosteroid Injection in Adhesive Capsulitis”. Clinical Rehabilitation. SAGE Publications. doi:10.1177/0269215508086179.
- De Carli, Angelo, Antonio Vadalà, Dario Perugia, Luciano Frate, Carlo Iorio, Mattia Fabbri, and Andrea Ferretti. 2011. “Shoulder Adhesive Capsulitis: Manipulation and Arthroscopic Arthrolysis or Intra-articular Steroid Injections?”. International Orthopaedics. Springer Science and Business Media LLC. doi:10.1007/s00264-011-1330-7.
- Maricar, N, C Shacklady, and L McLoughlin. 2009. “Effect of Maitland Mobilization and Exercises for the Treatment of Shoulder Adhesive Capsulitis: A Single-case Design”. Physiotherapy Theory and Practice. Informa UK Limited. doi:10.1080/09593980902776654.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Scott D Martin 2014. "Adhesive Capsulitis: Prospective Analysis of Efficacy and Financial Impact for Use of Physical Therapy in Treatment". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02283996.
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