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

Frozen Shoulder Clinical Trial

— TMACS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03090555
• Other study ID #: c2003.176
• Status: Completed
• Phase: N/A
• First received: March 14, 2017
• Last updated: March 20, 2017
• Start date: January 5, 2004
• Est. completion date: April 27, 2011

Study information

• Verified date: March 2017
• Source: Brooke Army Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: April 27, 2011
• Est. primary completion date: May 31, 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adhesive Capsulitis of Shoulder
• Bursitis
• Frozen Shoulder
• Periarthritis
• Rheumatic Diseases
• Shoulder Adhesive Capsulitis

Intervention

Procedure:
• Translational manipulation
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.
• Manual therapy
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.

Locations

Country	Name	City	State
United States	Brooke Army Medical Center	Fort Sam Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Daniel G. Rendeiro

Country where clinical trial is conducted

United States, 

References & Publications (2)

Placzek JD, Roubal PJ, Freeman DC, Kulig K, Nasser S, Pagett BT. Long-term effectiveness of translational manipulation for adhesive capsulitis. Clin Orthop Relat Res. 1998 Nov;(356):181-91. — View Citation

Placzek JD, Roubal PJ, Kulig K, Pagett BT, Wiater JM. Theory and technique of translational manipulation for adhesive capsulitis. Am J Orthop (Belle Mead NJ). 2004 Apr;33(4):173-9. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Shoulder Pain and Disability Index (SPADI)	Measure of individual pain and disability	baseline, 3 months, 6 months, 12 months, 48 months
Secondary	Percent of normal	Patient estimate of percent of full functional capacity of involved shoulder	48 months
Secondary	Activity limitations	Patient estimate of identified activities limited by involved shoulder function	48 months
Secondary	Medication use	Patient estimate of medications taken due to involved shoulder pain	48 months