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Completed

NCT Number: NCT03090555

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

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.

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Key information

Conditions

Shoulder Adhesive Capsulitis Adhesive Capsulitis of Shoulder Bursitis Frozen Shoulder Joint Diseases Musculoskeletal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brooke Army Medical Center

Fort Sam Houston, Texas, 78234, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Translational manipulation

Procedure

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

Procedure

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.

Primary outcomes

  1. Change in Shoulder Pain and Disability Index (SPADI)

    Time frame: baseline, 3 months, 6 months, 12 months, 48 months

    Measure of individual pain and disability

Secondary outcomes

  1. Percent of normal

    Time frame: 48 months

    Patient estimate of percent of full functional capacity of involved shoulder

  2. Activity limitations

    Time frame: 48 months

    Patient estimate of identified activities limited by involved shoulder function

  3. Medication use

    Time frame: 48 months

    Patient estimate of medications taken due to involved shoulder pain

Sponsors and collaborators

Lead sponsor

Daniel G. Rendeiro

Fed

Registry information

Official study title

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

Acronym: TMACS

Important dates

Study start
2004
Primary completion
2006
Study completion
2011
First posted
Mar 24, 2017
Registry last updated
Mar 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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