The Effectiveness of Translational Manipulation Under Interscalene Block for Treatment of Adhesive Capsulitis of the Shoulder: A Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 18
- Locations
- 2
- Primary Endpoint
- Change in Shoulder Pain and Disability Index (SPADI)
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
Outcomes assessors are blinded to the study arm to which participants are assigned
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Percent of normal(48 months)
- Activity limitations(48 months)
- Medication use(48 months)
Investigators
Daniel G. Rendeiro
Program Director
Brooke Army Medical Center