Adhesive Capsulitis: Prospective Analysis of Efficacy and Financial Impact for Use of Physical Therapy in Treatment
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorMassachusetts General Hospital
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Physical Therapy
Other interventionThe 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
Depot Methylprednisolone
Drug40 mg of depot methylprednisolone in solution with 2 cc of 1% lidocaine
Treatment groups
260 Participants
are divided into 2 treatment groupsGroup A: Physical Therapy with Steroid InjectionExperimental treatment 2 interventions
Group B: Watchful Waiting with Steroid InjectionExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
November 2014 to November 2023Secondary outcomes
1
Functional outcome based on the Disabilities of the Arm, Shoulder, and Hand (DASH) score sheet
At 1 year post-enrollment, patients will repeat the Disabilities of the Arm, Shoulder, and Hand (DASH) score sheet. The scores range from 0-100 with categorized subsets.
Time frame
November 2014 to November 20232
Functional outcome based on the Constant shoulder score sheet
At 1 year post-enrollment, patients will repeat the Constant shoulder score sheet. The scores range from 0-100 with categorized subsets.
Time frame
November 2014 to November 2023Sponsors and contacts
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Source ClinicalTrials.gov