Translational Manipulation Under Interscalene Block for Adhesive Capsulitis of the Shoulder (TMACS)

Not Applicable

Completed

• Conditions: Shoulder Adhesive Capsulitis; Frozen Shoulder; Adhesive Capsulitis of Shoulder

• Registration Number: NCT03090555
• Lead Sponsor: Daniel G. Rendeiro

Brief Summary

This study evaluates the addition of translational manipulation under interscalene block, to a course of orthopaedic manual physical therapy for treatment of adhesive capsulitis of the shoulder. Half the patients will receive a translational manipulation under interscalene block, plus 6 sessions of orthopaedic manual physical therapy. The other half will receive 7 sessions of physical therapy. The investigators hypothesize that the translational manipulation under interscalene block will provide additional benefit beyond the effect of in-clinic orthopaedic manual physical therapy alone.

Detailed Description

Both translational manipulation under interscalene block and in-clinic orthopaedic manual physical therapy are thought to be useful for treating adhesive capsulitis of the shoulder. However, no single intervention for this condition has been proven to be superior to others.

The translational manipulation under interscalene block may improve pain-free motion of the involved shoulder, by releasing tight tissue without the guarding and motion-limiting effect of active muscle tension. The interscalene block prevents the patient from actively contracting the muscles that control the involved shoulder, during the manipulation procedure.

One additional possible benefit of the translational manipulation under interscalene block, is that the technique loads the joint structures--bone, joint capsule--in a safer way with less angular torque than conventional/traditional manipulation under anaesthesia. This minimizes the risk of physical/mechanical harm from the procedure.

Study Timeline

• Study Start: 2004-01-05
• Primary Completion: 2006-05-31
• Study Completion: 2011-04-27
• Status Verified: 2017-03
• Study First Submitted: 2017-03-14
• Study First Submitted QC: 2017-03-20
• Last Update Submitted: 2017-03-20
• Study First Posted: 2017-03-24
• Last Update Posted: 2017-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• Military healthcare system beneficiaries 18 years old or older
• Chief complaint of loss of shoulder range of motion
• Passive glenohumeral abduction less than 75 degrees
• Sufficient English-language skills to understand the study protocol.

Exclusion Criteria

• Clinical diagnosis of diabetes (type I or II)
• Clinically evident and symptomatic rotator cuff tear or cervical radiculopathy
• Pain as the primary impairment (versus limitation of motion as the primary impairment)
• Having contraindications to an interscalene block.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Shoulder Pain and Disability Index (SPADI)	baseline, 3 months, 6 months, 12 months, 48 months	Measure of individual pain and disability

Secondary Outcome Measures

Name	Time	Method
Percent of normal	48 months	Patient estimate of percent of full functional capacity of involved shoulder
Activity limitations	48 months	Patient estimate of identified activities limited by involved shoulder function
Medication use	48 months	Patient estimate of medications taken due to involved shoulder pain

Trial Locations

Locations (1)

Brooke Army Medical Center; 🇺🇸 Fort Sam Houston, Texas, United States