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Clinical Trials/NCT02283996
NCT02283996RecruitingPhase 4

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

Massachusetts General Hospital1 site in 1 country260 target enrollmentStarted: November 1, 2014Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Recruiting
Enrollment
260
Locations
1
Primary Endpoint
Functional outcome based on the American Shoulder and Elbow Surgeons Standardized Questionnaire

Study Overview

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 Description

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 glenohumeral ligament is an important stabilizing structure in the positions of adduction and external rotation and abduction up to 45° in external rotation. The resistance, and therefore tension, of the inferior glenohumeral ligament, which is negligible in positions of neutral adduction and adduction in external rotation, increases in value for angles between 45° and 90°, indicating the important stabilizing function of this ligament in those positions. The rotator cuff is comprised of the tendons of the supraspinatus, infraspinatus, teres minor, and subscapularis muscles1,10.

In this disease state, there is a capsular pattern of shoulder dysfunction which is characterized by slight limitation of medial rotation, moderate limitation of passive abduction, and most importantly, severe limitation of lateral rotation. The finding of lateral rotation limitation or capsular pattern of limitation can be diagnostic in the assessment of AC.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Patient must be 18 years or older
  • Must meet the following definition for adhesive capsulitis as defined by the American Academy of Orthopedic Surgeons: 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; also called frozen shoulder
  • Must be amenable to randomization into either cohort

Exclusion Criteria

  • Non-English speaking patients
  • Pregnant women (women of childbearing potential will be advised to undergo regular pregnancy testing)
  • Patients who had previously undergone operative therapy for the condition

Arms & Interventions

Physical Therapy with Steroid Injection

Experimental

Patients will undergo regular physical therapy as defined by the standard of care at Massachusetts General Hospital for Adhesive Capsulitis (Frozen Shoulder). If they are in the inflammatory phase of the condition, they will receive 40 mg of depot methylprednisolone in solution with 2 cc of 1% lidocaine.

Intervention: Physical Therapy (Other)

Physical Therapy with Steroid Injection

Experimental

Patients will undergo regular physical therapy as defined by the standard of care at Massachusetts General Hospital for Adhesive Capsulitis (Frozen Shoulder). If they are in the inflammatory phase of the condition, they will receive 40 mg of depot methylprednisolone in solution with 2 cc of 1% lidocaine.

Intervention: Depot Methylprednisolone (Drug)

Watchful Waiting with Steroid Injection

Experimental

Patients will undergo no therapeutic intervention outside of steroid injection. If they are in the inflammatory phase of the condition, they will receive 40 mg of depot methylprednisolone in solution with 2 cc of 1% lidocaine.

Intervention: Depot Methylprednisolone (Drug)

Outcomes

Primary Outcomes

Functional outcome based on the American Shoulder and Elbow Surgeons Standardized Questionnaire

Time Frame: November 2014 to November 2023

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.

Secondary Outcomes

  • Functional outcome based on the Disabilities of the Arm, Shoulder, and Hand (DASH) score sheet(November 2014 to November 2023)
  • Functional outcome based on the Constant shoulder score sheet(November 2014 to November 2023)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Scott D Martin

Associate Professor of Orthopedic Surgery

Massachusetts General Hospital

Study Sites (1)

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