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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

March 14, 2017
March 20, 2017
January 5, 2004
May 31, 2006   (Final data collection date for primary outcome measure)
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
Same as current
No Changes Posted
  • 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
Same as current
Not Provided
Not Provided
 
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
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.

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.

Interventional
Not Provided
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
  • Shoulder Adhesive Capsulitis
  • Frozen Shoulder
  • Adhesive Capsulitis of Shoulder
  • 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.
  • 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.

    Interventions:
    • Procedure: Translational manipulation
    • Procedure: Manual therapy
  • 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.
    Intervention: Procedure: Manual therapy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
April 27, 2011
May 31, 2006   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT03090555
c2003.176
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
No
Not Provided
Daniel G. Rendeiro, Brooke Army Medical Center
Daniel G. Rendeiro
Not Provided
Principal Investigator: Daniel G. Rendeiro, DSc Army-Baylor University Doctoral Fellowship in Orthopaedic Manual Physical Therapy
Brooke Army Medical Center
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP