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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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

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 Summary: 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.
Sponsor: Boston Medical Center

Current Primary Outcome: Change in Shoulder Pain and Disability Index(SPADI) [ Time Frame: 6 months compared to baseline score ]

shoulder pain and disability index to evaluate shoulder pain and function


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: Boston Medical Center

Dates:
Date Received: January 7, 2017
Date Started: March 2016
Date Completion: September 2019
Last Updated: February 8, 2017
Last Verified: February 2017