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

Daniel G. Rendeiro

Status: Completed

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

Treatments: Procedure: Translational manipulation; Procedure: Manual therapy

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT03090555

c2003.176

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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18 participants in 2 patient groups

Translational Manipulation

Experimental group

Description:

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.

Treatment:

Procedure: Translational manipulation

Procedure: Manual therapy

Comparison Group

Active Comparator group

Description:

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.

Treatment:

Procedure: Manual therapy