Formal Physical Therapy (PT) vs. Home PT for Adhesive Capsulitis

Study Overview
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Brief Summary
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This study aims to evaluate physical therapy (standard of care) and home exercise vs. home exercise alone for the treatment of adhesive capsulitis.

Detailed Description
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Patients with adhesive capsulitis receive a glenohumeral and subacromial injection routinely for treatment. In addition, the patients are routinely prescribed physical therapy with a home exercise component. The purpose of this study is to evaluate whether home exercise alone is an alternative option to physical therapy. Patients will be approached about the study after they have agreed to receive a glenohumeral and subacromial injection per standard of care for their clinical treatment. The hypothesis being tested is whether home exercise is alone is as beneficial for pain relief, restoration of range of motion, and improvement in shoulder disability from adhesive capsulitis as physical therapy. Additionally sex differences, diabetes mellitus, endocrine, and mental health histories will be noted.

Official Title
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The Effectiveness of Traditional Physical Therapy Versus Home Exercise in Conjunction With Glenohumeral and Subacromial Corticosteroid Injection for the Treatment of Shoulder Adhesive Capsulitis

Conditions
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Adhesive Capsulitis

Intervention / Treatment
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* Other: Home Exercise Protocol
* Other: Physical Therapy Protocol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical Diagnosis of Adhesive Capsulitis (limited range of motion) Given glenohumeral and subacromial injection as part of standard care. Capacity to conduct home exercise program or physical therapy (based upon physician judgment, proximity to physical therapy office and as decided by patient) English speaking 18 years of age or greater Exclusion Criteria: Prior glenohumeral or subacromial corticosteroid injection within 6 months Prior ipsilateral shoulder surgery Current prescription (narcotic) pain medication use Pain disorder (ex. Fibromyalgia, Reflex Sympathetic Dystrophy) Cervical radiculopathy Full-thickness rotator cuff tear Calcific Tendinopathy (past or present) Advanced Stage osteoarthritis as seen on radiograph Past/present ipsilateral shoulder fracture Women that may be pregnant or nursing (self report) Past/present physical therapy treatment will be documented, but will not be considered an exclusion factor. The reasoning behind this is that the physical therapy likely was not properly targeting the adhesive capsulitis for the patient to arrive in an orthopaedic clinic and is likely at a similar starting point to most other patients regardless of previous physical therapy. All patients currently enrolled in physical therapy will be assigned to either our physical therapy or home exercise program.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: home exercise<br>For the home exercise protocol alone arm, subjects will be given an experimental home exercise program and study team will demonstrate the exercises in the clinic and will direct the subjects to perform the exercises 1-2 times daily until symptom resolution. | Other: Home Exercise Protocol<br>* Home exercise therapy protocol given to patient to be completed at home.<br>|
| Active Comparator: physical therapy<br>Patients will be prescribed routine physical therapy protocol where they will see a physical therapist twice a week and will be instructed by the physical therapist to perform physical therapy exercises at home daily until symptom resolution, as is the routine practice. | Other: Physical Therapy Protocol<br>* Formal physical therapy protocol to be given to physical therapist working with patient to direct formal intervention along with a home therapy protocol.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Shoulder Pain and Disability Index(SPADI) | shoulder pain and disability index to evaluate shoulder pain and function | 6 months compared to baseline score | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Range of Motion (ROM) | evaluate range of motion | 6 months compared to baseline score | 
| Change in Sane Normal and Pain Visual Analogue Score (SANE) | Subjective shoulder score to determine shoulder pain/function | 6 months compared to baseline score | 
| Change in Mental Health Index- 5 (MHI-5) | Mental Health Index- 5 to determine patient mental health status | 6 months compared to baseline score | 
| Change in Short Form- 36 (SF-36) | Short Form Survey- 36 to determine general overall health for patient | 6 months compared to baseline score | 
| Change in Visual Analog Scale Pain (VAS-Pain) | Visual analog scale- pain to assess shoulder pain | 6 months compared to baseline score | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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physical therapy, home exercise, adhesive capsulitis