NCT03090555

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 5, 2004

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2006

Completed
4.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 27, 2011

Completed
5.9 years until next milestone

First Submitted

Initial submission to the registry

March 14, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 24, 2017

Completed
Last Updated

March 24, 2017

Status Verified

March 1, 2017

Enrollment Period

2.4 years

First QC Date

March 14, 2017

Last Update Submit

March 20, 2017

Conditions

Shoulder Adhesive CapsulitisFrozen ShoulderAdhesive Capsulitis of Shoulder

Keywords

adhesive capsulitisclinical trialmanipulation

Outcome Measures

Primary Outcomes (1)

  • Change in Shoulder Pain and Disability Index (SPADI)

    Measure of individual pain and disability

    baseline, 3 months, 6 months, 12 months, 48 months

Secondary Outcomes (3)

  • Percent of normal

    48 months

  • Activity limitations

    48 months

  • Medication use

    48 months

Study Arms (2)

Translational Manipulation

EXPERIMENTAL

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 manipulationProcedure: Manual therapy

Comparison Group

ACTIVE COMPARATOR

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

Interventions

Translational manipulationPROCEDURE

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.

Translational Manipulation
Manual therapyPROCEDURE

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.

Comparison GroupTranslational Manipulation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brooke Army Medical Center

Fort Sam Houston, Texas, 78234, United States

Location

Related Publications (2)

  • 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.

    PMID: 15132324RESULT

  • 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.

    PMID: 9917683RESULT

MeSH Terms

Conditions

Bursitis

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Daniel G. Rendeiro, DSc

    Army-Baylor University Doctoral Fellowship in Orthopaedic Manual Physical Therapy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcomes assessors are blinded to the study arm to which participants are assigned
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Program Director

Study Record Dates

First Submitted

March 14, 2017

First Posted

March 24, 2017

Study Start

January 5, 2004

Primary Completion

May 31, 2006

Study Completion

April 27, 2011

Last Updated

March 24, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)