Clinical Trial: Adhesive Capsulitis: Prospective Analysis of Efficacy and Financial Impact for Use of Physical Therapy in Treatment

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Adhesive Capsulitis: Prospective Analysis of Efficacy and Financial Impact for Use of Physical Therapy in Treatment

Brief Summary: The purpose of this study is to identify individuals 18 or older who have diagnostic presentation of adhesive capsulitis and randomize them into two arms, distinguished by use of physical therapy and steroid injections compared with steroid injections followed by watchful waiting. This prospective study will be used to determine whether there is a significant impact on patient outcome and whether the additional financial burden is justified. There are no experimental interventions for this study. The use of physical therapy, oral and parenteral corticosteroids, and watchful waiting are offered following the standard of care for adhesive capsulitis. Our hypothesis is that patients will not have a significant difference in outcome between the two study arms. One group will undergo regular physical therapy with corticosteroid injections (Arm 1) and the other will have steroid injections during the inflammatory phase only and then be regularly observed (Arm 2). We also hypothesize there will be a significant financial burden associated with the PT arm that is not justified with the possibility of increased symptom reports in that arm.

Detailed Summary:

A. Objectives

The purpose of this study is to identify individuals 18 or older who have diagnostic presentation of adhesive capsulitis and randomize them into two arms, distinguished by use of physical therapy and steroid injections compared with steroid injections followed by watchful waiting. This prospective study will be used to determine whether there is a significant impact on patient outcome and whether the additional financial burden is justified. The standard of care calls for initial non-operative therapy consisting of NSAIDs, watchful waiting, and oral and parenteral corticosteroid administration with consideration for operative therapy after 6 months of failed conservative therapy. We would like to enroll patients who are willing to be randomized and postpone operative therapy for a period of up to one year during which we would have scheduled follow up visits at regular intervals. There are no experimental interventions for this study. The use of physical therapy, oral and parenteral corticosteroids, and watchful waiting are offered following the standard of care for adhesive capsulitis.

B. Background Adhesive capsulitis, also known as "frozen shoulder" is a common orthopedic condition affecting 2-5% of the general population13. As defined by the American Academy of Orthopedic Surgeons, it is a self-limiting condition resulting from any inflammatory process about the shoulder in which capsular scar tissue is produced, resulting in pain and limited range of motion.

The majority of shoulder function comes from the interactions of the glenohumeral ligament complex, the rotator cuff complex, and the articulating bones. The superior glenohumeral ligament is important in stabilization of the glenohumeral joint in adduction and external rotation. The middle
Sponsor: Massachusetts General Hospital

Current Primary Outcome: Functional outcome based on the American Shoulder and Elbow Surgeons Standardized Questionnaire [ Time Frame: November 2014 to November 2017 ]

At 1 year post-enrollment, patients will repeat the American Shoulder and Elbow Surgeons Standardized questionnaire. The scores range from 0-100 with categorized subsets.


Original Primary Outcome: Functional outcome based on the American Shoulder and Elbow Surgeons Standardized Questionnaire [ Time Frame: November 2014 to November 2015 ]

At 6 weeks, 3 months, 6 months, and 1 year post-enrollment, patients will repeat the American Shoulder and Elbow Surgeons Standardized questionnaire. The scores range from 0-100 with categorized subsets.


Current Secondary Outcome:

  • Functional outcome based on the Disabilities of the Arm, Shoulder, and Hand (DASH) score sheet [ Time Frame: November 2014 to November 2017 ]
    At 1 year post-enrollment, patients will repeat the Disabilities of the Arm, Shoulder, and Hand (DASH) score sheet. The scores range from 0-100 with categorized subsets.
  • Functional outcome based on the Constant shoulder score sheet [ Time Frame: November 2014 to November 2017 ]
    At 1 year post-enrollment, patients will repeat the Constant shoulder score sheet. The scores range from 0-100 with categorized subsets.


Original Secondary Outcome:

  • Functional outcome based on the Disabilities of the Arm, Shoulder, and Hand (DASH) score sheet [ Time Frame: November 2014 to November 2015 ]
    At 6 weeks, 3 months, 6 months, and 1 year post-enrollment, patients will repeat the Disabilities of the Arm, Shoulder, and Hand (DASH) score sheet. The scores range from 0-100 with categorized subsets.
  • Functional outcome based on the Constant shoulder score sheet [ Time Frame: November 2014 to November 2015 ]
    At 6 weeks, 3 months, 6 months, and 1 year post-enrollment, patients will repeat the Constant shoulder score sheet. The scores range from 0-100 with categorized subsets.


Information By: Massachusetts General Hospital

Dates:
Date Received: October 31, 2014
Date Started: November 2014
Date Completion: May 2018
Last Updated: January 31, 2017
Last Verified: January 2017