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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Daniel G. Rendeiro, Brooke Army Medical Center
ClinicalTrials.gov Identifier:
NCT03090555
First received: March 14, 2017
Last updated: March 20, 2017
Last verified: March 2017
  Purpose
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.

Condition Intervention
Shoulder Adhesive Capsulitis
Frozen Shoulder
Adhesive Capsulitis of Shoulder
Procedure: Translational manipulation
Procedure: Manual therapy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Outcomes Assessor
Masking Description:
Outcomes assessors are blinded to the study arm to which participants are assigned
Primary Purpose: Treatment
Official Title: The Effectiveness of Translational Manipulation Under Interscalene Block for Treatment of Adhesive Capsulitis of the Shoulder: A Randomized Clinical Trial

Further study details as provided by Brooke Army Medical Center:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Percent of normal [ Time Frame: 48 months ]
    Patient estimate of percent of full functional capacity of involved shoulder

  • Activity limitations [ Time Frame: 48 months ]
    Patient estimate of identified activities limited by involved shoulder function

  • Medication use [ Time Frame: 48 months ]
    Patient estimate of medications taken due to involved shoulder pain


Enrollment: 18
Actual Study Start Date: January 5, 2004
Study Completion Date: April 27, 2011
Primary Completion Date: May 31, 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Translational Manipulation

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
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.
Procedure: 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.
Active Comparator: Comparison Group
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
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.

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03090555

Locations
United States, Texas
Brooke Army Medical Center
Fort Sam Houston, Texas, United States, 78234
Sponsors and Collaborators
Daniel G. Rendeiro
Investigators
Principal Investigator: Daniel G. Rendeiro, DSc Army-Baylor University Doctoral Fellowship in Orthopaedic Manual Physical Therapy
  More Information

Publications:
Responsible Party: Daniel G. Rendeiro, Program Director, Brooke Army Medical Center
ClinicalTrials.gov Identifier: NCT03090555     History of Changes
Other Study ID Numbers: c2003.176
Study First Received: March 14, 2017
Last Updated: March 20, 2017
Individual Participant Data  
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Brooke Army Medical Center:
adhesive capsulitis
clinical trial
manipulation

Additional relevant MeSH terms:
Periarthritis
Rheumatic Diseases
Bursitis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Connective Tissue Diseases

ClinicalTrials.gov processed this record on March 24, 2017