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Trial record 24 of 27 for:    Recruiting, Not yet recruiting, Available Studies | "Reflex Sympathetic Dystrophy"

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

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ClinicalTrials.gov Identifier: NCT02957240
Recruitment Status : Recruiting
First Posted : November 7, 2016
Last Update Posted : April 18, 2019
Sponsor:
Collaborators:
American Hand Therapy Foundation
Fairview Health Services
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Musculoskeletal Pain Fractures, Closed Distal Radius Fracture Complex Regional Pain Syndromes Behavioral: Standard Care Behavioral: Motor Representation Techniques Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021


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.





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

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


Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02957240


Contacts
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Contact: Corey W McGee, PhD 952-607-6387 mcge0062@umn.edu
Contact: Virginia O'Brien, OTD 612-273-7100 VOBRIEN1@Fairview.org

Locations
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United States, Minnesota
University of Minnesota Program in Occupational Therapy Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Corey McGee, PhD    507-258-8016    mcge0062@umn.edu   
Principal Investigator: Corey W McGee, PhD         
Sub-Investigator: Ann Van Heest, MD         
Sub-Investigator: Virginia O'Brien, OTD         
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
American Hand Therapy Foundation
Fairview Health Services
Investigators
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Principal Investigator: Corey W McGee, PhD University of Minnesota, Program in Occupational Therapy

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT02957240     History of Changes
Other Study ID Numbers: McGeeCW
First Posted: November 7, 2016    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
Forearm [A01.378.800.585]
Radius [A02.835.232.087.090.700]
Motor Skills [F02.808.260]
Task Performance and Analysis [F02.808.600]
Casts, Surgical [E07.858.442.660.430.500]
Splints [E07.858.690.725.430.750]
motor representation techniques
mirror therapy
Women [M01.975]

Additional relevant MeSH terms:
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Complex Regional Pain Syndromes
Reflex Sympathetic Dystrophy
Fractures, Bone
Radius Fractures
Musculoskeletal Pain
Fractures, Closed
Wounds and Injuries
Forearm Injuries
Arm Injuries
Muscular Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Autonomic Nervous System Diseases
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases