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

Primary Purpose

Shoulder Adhesive Capsulitis, Frozen Shoulder, Adhesive Capsulitis of Shoulder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Translational manipulation
Manual therapy
Sponsored by
Daniel G. Rendeiro
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Adhesive Capsulitis focused on measuring adhesive capsulitis, clinical trial, manipulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Brooke Army Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Translational Manipulation

Comparison Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in Shoulder Pain and Disability Index (SPADI)
Measure of individual pain and disability

Secondary Outcome Measures

Percent of normal
Patient estimate of percent of full functional capacity of involved shoulder
Activity limitations
Patient estimate of identified activities limited by involved shoulder function
Medication use
Patient estimate of medications taken due to involved shoulder pain

Full Information

First Posted
March 14, 2017
Last Updated
March 20, 2017
Sponsor
Daniel G. Rendeiro
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1. Study Identification

Unique Protocol Identification Number
NCT03090555
Brief Title
Translational Manipulation Under Interscalene Block for Adhesive Capsulitis of the Shoulder (TMACS)
Acronym
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

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
January 5, 2004 (Actual)
Primary Completion Date
May 31, 2006 (Actual)
Study Completion Date
April 27, 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Daniel G. Rendeiro

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Adhesive Capsulitis, Frozen Shoulder, Adhesive Capsulitis of Shoulder
Keywords
adhesive capsulitis, clinical trial, manipulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Outcomes assessors are blinded to the study arm to which participants are assigned
Allocation
Non-Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Translational Manipulation
Arm Type
Experimental
Arm Description
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.
Arm Title
Comparison Group
Arm Type
Active Comparator
Arm Description
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 Type
Procedure
Intervention Name(s)
Translational manipulation
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Manual therapy
Intervention Description
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 Outcome Measure Information:
Title
Change in Shoulder Pain and Disability Index (SPADI)
Description
Measure of individual pain and disability
Time Frame
baseline, 3 months, 6 months, 12 months, 48 months
Secondary Outcome Measure Information:
Title
Percent of normal
Description
Patient estimate of percent of full functional capacity of involved shoulder
Time Frame
48 months
Title
Activity limitations
Description
Patient estimate of identified activities limited by involved shoulder function
Time Frame
48 months
Title
Medication use
Description
Patient estimate of medications taken due to involved shoulder pain
Time Frame
48 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel G. Rendeiro, DSc
Organizational Affiliation
Army-Baylor University Doctoral Fellowship in Orthopaedic Manual Physical Therapy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brooke Army Medical Center
City
Fort Sam Houston
State/Province
Texas
ZIP/Postal Code
78234
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
15132324
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.
Results Reference
result
PubMed Identifier
9917683
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.
Results Reference
result

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

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