Clinical trial NCT03090555: Translational Manipulation Under Interscalene Block for Adhesive Capsulitis of the Shoulder (TMACS)
Official title: The Effectiveness of Translational Manipulation Under Interscalene Block for Treatment of Adhesive Capsulitis of the Shoulder: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder Adhesive Capsulitis
Frozen Shoulder
Adhesive Capsulitis of Shoulder
Keywords: adhesive capsulitis
clinical trial
manipulation
Lead sponsor: Brooke Army Medical Center
Sponsor class: FED
First posted: 2017-03-24
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Shoulder Pain and Disability Index (SPADI)
timeFrame: baseline, 3 months, 6 months, 12 months, 48 months
Secondary outcomes:
measure: Percent of normal
timeFrame: 48 months
measure: Activity limitations
timeFrame: 48 months
measure: Medication use
timeFrame: 48 months
Other outcomes:
Locations:
city: Fort Sam Houston
country: United States
facility: Brooke Army Medical Center
state: Texas
Study officials:
affiliation: Army-Baylor University Doctoral Fellowship in Orthopaedic Manual Physical Therapy
name: Daniel G. Rendeiro, DSc
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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. doi: 10.1097/00003086-199811000-00025.