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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: The Effectiveness of Translational Manipulation Under Interscalene Block for Treatment of Adhesive Capsulitis of the Shoulder: A Randomized Clinical Trial

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 Summary:

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.


Sponsor: Daniel G. Rendeiro

Current Primary Outcome: Change in Shoulder Pain and Disability Index (SPADI) [ Time Frame: baseline, 3 months, 6 months, 12 months, 48 months ]

Measure of individual pain and disability


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: Brooke Army Medical Center

Dates:
Date Received: March 14, 2017
Date Started: January 5, 2004
Date Completion:
Last Updated: March 20, 2017
Last Verified: March 2017