Clinical trial NCT03049787: Formal Physical Therapy (PT) vs. Home PT for Adhesive Capsulitis
Official title: The Effectiveness of Traditional Physical Therapy Versus Home Exercise in Conjunction With Glenohumeral and Subacromial Corticosteroid Injection for the Treatment of Shoulder Adhesive Capsulitis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Adhesive Capsulitis
Keywords: physical therapy
home exercise
adhesive capsulitis
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: Brigham and Women's Hospital
First posted: 2017-02-10
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in Shoulder Pain and Disability Index(SPADI)
timeFrame: 6 months compared to baseline score
Secondary outcomes:
measure: Change in Range of Motion (ROM)
timeFrame: 6 months compared to baseline score
measure: Change in Sane Normal and Pain Visual Analogue Score (SANE)
timeFrame: 6 months compared to baseline score
measure: Change in Mental Health Index- 5 (MHI-5)
timeFrame: 6 months compared to baseline score
measure: Change in Short Form- 36 (SF-36)
timeFrame: 6 months compared to baseline score
measure: Change in Visual Analog Scale Pain (VAS-Pain)
timeFrame: 6 months compared to baseline score
Other outcomes:
Locations:
Study officials:
affiliation: Boston Medical Center
name: Xinning Li, MD
role: PRINCIPAL_INVESTIGATOR
References: