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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03090555
Acronym
TMACS
Enrollment
18
Registered
2017-03-24
Start date
2004-01-05
Completion date
2011-04-27
Last updated
2017-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adhesive Capsulitis of Shoulder, Frozen Shoulder, Shoulder Adhesive Capsulitis

Keywords

adhesive capsulitis, clinical trial, manipulation

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.

Interventions

PROCEDURETranslational 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.

PROCEDUREManual 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.

Sponsors

Daniel G. Rendeiro
Lead SponsorFED

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

Outcomes assessors are blinded to the study arm to which participants are assigned

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in Shoulder Pain and Disability Index (SPADI)baseline, 3 months, 6 months, 12 months, 48 monthsMeasure of individual pain and disability

Secondary

MeasureTime frameDescription
Percent of normal48 monthsPatient estimate of percent of full functional capacity of involved shoulder
Activity limitations48 monthsPatient estimate of identified activities limited by involved shoulder function
Medication use48 monthsPatient estimate of medications taken due to involved shoulder pain

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026