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

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

Sponsors

Lead sponsor: Boston Medical Center

Collaborator: Brigham and Women's Hospital

Source Boston Medical Center
Brief Summary

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

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.

Overall Status Not yet recruiting
Start Date July 2020
Completion Date December 2021
Primary Completion Date December 2021
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Change in Shoulder Pain and Disability Index(SPADI) 6 months compared to baseline score
Secondary Outcome
Measure Time Frame
Change in Range of Motion (ROM) 6 months compared to baseline score
Change in Sane Normal and Pain Visual Analogue Score (SANE) 6 months compared to baseline score
Change in Mental Health Index- 5 (MHI-5) 6 months compared to baseline score
Change in Short Form- 36 (SF-36) 6 months compared to baseline score
Change in Visual Analog Scale Pain (VAS-Pain) 6 months compared to baseline score
Enrollment 72
Condition
Intervention

Intervention type: Other

Intervention name: Home Exercise Protocol

Description: Home exercise therapy protocol given to patient to be completed at home.

Arm group label: home exercise

Intervention type: Other

Intervention name: Physical Therapy Protocol

Description: Formal physical therapy protocol to be given to physical therapist working with patient to direct formal intervention along with a home therapy protocol.

Arm group label: physical therapy

Eligibility

Criteria:

Inclusion Criteria:

1. Clinical Diagnosis of Adhesive Capsulitis (limited range of motion)

2. Given glenohumeral and subacromial injection as part of standard care.

3. Capacity to conduct home exercise program or physical therapy (based upon physician judgment, proximity to physical therapy office and as decided by patient)

4. English speaking

5. 18 years of age or greater

Exclusion Criteria:

1. Prior glenohumeral or subacromial corticosteroid injection within 6 months

2. Prior ipsilateral shoulder surgery

3. Current prescription (narcotic) pain medication use

4. Pain disorder (ex. Fibromyalgia, Reflex Sympathetic Dystrophy)

5. Cervical radiculopathy

6. Full-thickness rotator cuff tear

7. Calcific Tendinopathy (past or present)

8. Advanced Stage osteoarthritis as seen on radiograph

9. Past/present ipsilateral shoulder fracture

10. 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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Xinning Li, MD Principal Investigator Boston Medical Center
Overall Contact

Last name: Emily J Curry, BA

Phone: 5088736920

Email: [email protected]

Verification Date

May 2020

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: home exercise

Arm group type: Experimental

Description: 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.

Arm group label: physical therapy

Arm group type: Active Comparator

Description: 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.

Patient Data No
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov