An interventional study of Translational manipulation and Manual therapy in Shoulder Adhesive Capsulitis, Frozen Shoulder and Adhesive Capsulitis of Shoulder, sponsored by Daniel G. Rendeiro. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-03-24.
Sponsored by Daniel G. Rendeiro · Not applicable, Interventional, and Treatment
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.
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.
411 studies on the registry are indexed under Bursitis; 112 are open to participants now.
This study's enrollment of 18 is below the median of 45 across 371 interventional studies indexed under Bursitis.
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Exclusion Criteria:
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.
Procedure: Translational manipulation · Procedure: 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.
Procedure: Manual therapy
After the patient receives an interscalene block on the affected side, a physical therapist performs a series of thrust manipulations on the participant's affected shoulder. The participant's identified limitations of physiological and accessory motion revealed during manual examination guided the physical therapist's choice of technique, which primarily consisted of an accessory superior to inferior accessory gliding motion performed in a physiological position of limited motion. Additional gliding manipulations in combined movement positions such as increased flexion or abduction plus internal or external rotation were utilized until full passive physiologic motion was restored.
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 manual therapy (MT) by a physical therapist that included all indicated grades of non-thrust manipulation of the joints and soft tissue. The MT intervention was targeted toward any identifiable upper quarter pain or movement impairments. Subsequent clinic treatment sessions included additional MT, progression of the strengthening exercises, and reinforcement of the home program.
Change in Shoulder Pain and Disability Index (SPADI)
Measure of individual pain and disability
Time frame: baseline, 3 months, 6 months, 12 months, 48 months
Percent of normal
Patient estimate of percent of full functional capacity of involved shoulder
Time frame: 48 months
Activity limitations
Patient estimate of identified activities limited by involved shoulder function
Time frame: 48 months
Medication use
Patient estimate of medications taken due to involved shoulder pain
Time frame: 48 months
Plan to share: No
This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
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