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The study was never started as the PI was working on another clinical trial.
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| Name | Class |
|---|---|
| Brigham and Women's Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| home exercise | Experimental | 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. |
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| physical therapy | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Home Exercise Protocol | Other | Home exercise therapy protocol given to patient to be completed at home. |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Xinning Li, MD | Boston Medical Center | Principal Investigator |
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| ID | Term |
|---|---|
| D002062 | Bursitis |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| Physical Therapy Protocol | Other | Formal physical therapy protocol to be given to physical therapist working with patient to direct formal intervention along with a home therapy protocol. |
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| 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 |