Graded Motor Imagery for Women at Risk for Developing Type I CRPS Following Closed Treatment of Distal Radius Fractures

August 20, 2024 updated by: University of Minnesota

Graded Motor Imagery for Women at Risk for Developing Type I CRPS Following Closed Treatment of Distal Radius Fractures: A Pilot Randomized Comparative Effectiveness Trial

Nearly 2 out of 10 women will sustain a distal forearm fracture throughout their lifespan.Recent longitudinal studies illustrate that as many as 1/3 of all persons who undergo closed reduction and casting for distal radius fractures (DRF) go on to develop type 1 complex regional pain syndrome (CRPS). Graded motor imagery (i.e., motor imagery and mirror therapy), a movement representation technique, is strongly supported in the literature as a treatment of CRPS and has recently been suggested as a potential strategy to prevent its onset. Other complications include disability, wrist/forearm tightness and sensorimotor changes.

The investigators propose that an early intervention protocol which includes graded motor imagery (GMI) will improve the pain, functional and upper limb sensorimotor outcomes of persons following closed reduction and casting of DRF relative to a standard of care intervention.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Distal radius fractures (DRF) account for nearly one-fifth of all fractures in older adults with women sustaining them at a rate of 5 to 1 relative to their male counterparts. The majority of DRF occur as a result of low impact injuries to the wrist with the hand being outstretched and are most often managed via closed treatment and cast immobilization The aftereffects of these injuries include pain, distal upper limb immobility, distal sensorimotor changes, hand weakness, edema, and type I complex CRPS development. Women, those sustaining low-force injuries, and those who undergo closed treatment and cast immobilization of the DRF, are at increased risk for developing type I CRPS. Given that alterations in the brain's somatosensory strip likely influence CRPS development, a newer intervention, graded motor imagery, is being used to restore the affected limbs cortical representation to its typical state. Beyond pain reduction, the implications of this type of approach also include restoring sensorimotor function to the affected limb. Evidence supports that these interventions can impact CRPS symptoms as well as motor function but only after they've developed. To date, there is no literature exploring how these techniques, specifically graded motor imagery, can be applied to prevent or mitigate the aforementioned aftereffects of DRF in women.

To this end the investigators propose to pilot a 6-week randomized comparative effectiveness trial, where the modified graded motor imagery program + standard of care group is compared to a standard of care (SOC) control group. Immediately following cast immobilization, the intervention group and control group will each participate in one 1-hr and three 30-minute clinic-based sessions and 15 minute home programs three times daily. Blinded assessments will occur at baseline, 3 weeks, cast removal, and one and 3 months after cast removal and will include pain, sensorimotor, edema, and CRPS diagnostic outcomes.

The project's aims are to: 1) determine the feasibility of recruiting, enrolling, treating, and following participants and 2) determine if those who participate in a GMI and SOC hand therapy program have differing pain, function, and counts of CRPS diagnoses when compared to those who receive only the SOC. The investigators hypothesize 1) that the project will be feasible to carry out on a larger scale and 2) that an early GMI will improve the pain, functional and upper limb sensorimotor outcomes of persons with closed treatment of DRF relative to a standard of care intervention.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota Program in Occupational Therapy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Women 55 years or older who have received closed treatment of distal radius fractures

Exclusion Criteria:

  • Central nervous system disorders (e.g., Brain injury, Spinal Cord Injury, Parkinson's, Multiple Sclerosis)
  • Surgical fixation of fracture
  • Non english speaking
  • Concomitant ipsilateral injuries (i..e., BBFF)
  • Other injuries to the affected limb interfering with baseline affected limb function
  • Cognitive disorders which would preclude from following the testing commands and home program participation
  • Conditions of the contralateral upper limb which would result in painful and markedly limited active hand, wrist and forearm motion as this may impact the brain's ability to perceive safe and proficient movement during mirror therapy.
  • Visual impairments resulting in the inability to participate in GMI components

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard Care
Four clinic-based intervention sessions where the focus will be on home program competency and advancement and standard home program 3x daily for 15 minutes.
Behavioral: Standard Care

This group will partake in 4 clinic-based intervention sessions (one 1-hr. and 3 subsequent 30-minute sessions) where the focus will be on home program competency/advancement. Session 1 will occur within 1 week of cast treatment, session 2 in week 2, session 3 in week 4, and session 4 in week 5.

Home program (3x daily, 15 minutes) to include 10 repetitions of active thumb opposition, active thumb radial abduction, intrinsic minus active stretches, flat fist and composite, finger extension, Elbow flexion and extension, Shoulder scapular rolls, and glenohumeral circumduction.

Edema will be addressed through strict elevation when at rest and every 10 minutes on the hour. When resting in a seated or supine position, clients will be instructed to use pillows to accomplish elevation and to keep elbows in an extended position. Instructions for elevation will be provided immediately following orthopaedic intervention. Strict elevation will be recommended for the first 72 hours of the injury.
Experimental: Standard Care and Motor Representation Techniques
4 clinic-based intervention sessions including 'standard care' intervention in addition to a 'movement representation' intervention. Home Program for Standard Care and Motor Representation 3x daily for 30 minutes.
Behavioral: Standard Care

This group will partake in 4 clinic-based intervention sessions (one 1-hr. and 3 subsequent 30-minute sessions) where the focus will be on home program competency/advancement. Session 1 will occur within 1 week of cast treatment, session 2 in week 2, session 3 in week 4, and session 4 in week 5.

Home program (3x daily, 15 minutes) to include 10 repetitions of active thumb opposition, active thumb radial abduction, intrinsic minus active stretches, flat fist and composite, finger extension, Elbow flexion and extension, Shoulder scapular rolls, and glenohumeral circumduction.

Edema will be addressed through strict elevation when at rest and every 10 minutes on the hour. When resting in a seated or supine position, clients will be instructed to use pillows to accomplish elevation and to keep elbows in an extended position. Instructions for elevation will be provided immediately following orthopaedic intervention. Strict elevation will be recommended for the first 72 hours of the injury.

Behavioral: Motor Representation Techniques

Those in this group will receive 4 clinic-based intervention session (one 1-hr. and three subsequent 30-minute sessions) where the focus will be on home program competency and advancement. Session 1 will occur within 1 week of cast treatment, session 2 in week 2, session 3 in week 4, and session 4 in week 5.

Home Program will be performed 3x daily for 15 minutes. A Motor Representation Technique (i.e., modified GMI) protocol described by Lagueux et al. will be employed. As originally designed the program was broken into three stages 1) Laterality, 2) Explicit Motor Imagery, 3) Mirror therapy with unaffected hand only and 4) Mirror Therapy with bilateral hands. For the purpose of this study, and given the restraint offered by cast immobilization, the 4th phase will not be used. Each phase will require 1-2 weeks and will be progressed at the discretion of the hand therapist interventionist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in The McGill Pain Scale - Short Form(SF-MPQ) Scores
Time Frame: Change from baseline to 18 weeks
Change from baseline to 18 weeks
Change in Patient Rated Wrist Evaluation (PRWE) Scores
Time Frame: Change from baseline to 18 weeks
Change from baseline to 18 weeks
Assessment of Veldman CRPS Type I Diagnostic Criteria
Time Frame: 18 weeks
18 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in joint position sense goniometry of wrist and forearm
Time Frame: Change from baseline to 18 weeks
Change from baseline to 18 weeks
Change in Goniometry of wrist and forearm
Time Frame: Change from baseline to 18 weeks
Change from baseline to 18 weeks
Change in Grip Dynamometry (% of Unaffected)
Time Frame: Change from baseline to 18 weeks
Change from baseline to 18 weeks
Therapy Adherence Log
Time Frame: up to 18 weeks
up to 18 weeks
Change in Circumferential Edema measurements of 2nd and 3rd digits
Time Frame: Change from baseline to 18 weeks
Change from baseline to 18 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minnesota

Collaborators

Fairview Health Services
American Hand Therapy Foundation

Investigators

  • Principal Investigator: Corey W McGee, PhD, University of Minnesota, Program in Occupational Therapy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2018

Primary Completion (Actual)

June 30, 2024

Study Completion (Actual)

June 30, 2024

Study Registration Dates

First Submitted

October 25, 2016

First Submitted That Met QC Criteria

November 3, 2016

First Posted (Estimated)

November 6, 2016

Study Record Updates

Last Update Posted (Actual)

August 21, 2024

Last Update Submitted That Met QC Criteria

August 20, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OT-2016-24458

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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