Translational Manipulation Under Interscalene Block for Adhesive Capsulitis of the Shoulder (TMACS)
- Conditions
- Shoulder Adhesive CapsulitisFrozen ShoulderAdhesive Capsulitis of Shoulder
- Interventions
- Procedure: Translational manipulationProcedure: Manual therapy
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
- 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.
- 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
- Arm && Interventions
Group Intervention Description Translational Manipulation Manual therapy Participants received an interscalene block on the affected side. Then, a physical therapist performed thrust manipulations on the affected shoulder until full passive physiologic motion was restored. These participants returned to the clinic approximately 3 days later for the first of 6 manual therapy (MT) sessions. The first clinic treatment session included instruction in a home program of static stretching, resistive exercise, and ice, issue of an illustrated handout and digital video disc detailing the same program, and manual therapy (MT) by a physical therapist that included all indicated grades of non-thrust manipulation. Subsequent clinic treatment sessions included additional MT, progression of the strengthening exercises, and reinforcement of the home program. Comparison Group Manual therapy Participants in the comparison group did not undergo a session of translational manipulation. In order to equalize the number of intervention sessions, members of this group underwent 7 in-clinic sessions of manual therapy (MT). The first clinic treatment session for all study participants included instruction in the home program of static stretching, resistive exercise, and ice, issue of an illustrated handout and digital video disc detailing the same program, and MT by a physical therapist that included all indicated grades of non-thrust manipulation. Subsequent clinic treatment sessions included additional MT, progression of the strengthening exercises, and reinforcement of the home program. Translational Manipulation Translational manipulation Participants received an interscalene block on the affected side. Then, a physical therapist performed thrust manipulations on the affected shoulder until full passive physiologic motion was restored. These participants returned to the clinic approximately 3 days later for the first of 6 manual therapy (MT) sessions. The first clinic treatment session included instruction in a home program of static stretching, resistive exercise, and ice, issue of an illustrated handout and digital video disc detailing the same program, and manual therapy (MT) by a physical therapist that included all indicated grades of non-thrust manipulation. Subsequent clinic treatment sessions included additional MT, progression of the strengthening exercises, and reinforcement of the home program.
- 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