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 |
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Recruitment Status :
Recruiting
First Posted : November 6, 2016
Last Update Posted : January 24, 2022
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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 |
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 (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 2022 |
| Estimated Study Completion Date : | December 2022 |
| Arm | Intervention/treatment |
|---|---|
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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.
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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. |
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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.
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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. |
- Change in The McGill Pain Scale - Short Form(SF-MPQ) Scores [ Time Frame: Change from baseline to 18 weeks ]
- Change in Patient Rated Wrist Evaluation (PRWE) Scores [ Time Frame: Change from baseline to 18 weeks ]
- Assessment of Veldman CRPS Type I Diagnostic Criteria [ Time Frame: 18 weeks ]
- Change in joint position sense goniometry of wrist and forearm [ Time Frame: Change from baseline to 18 weeks ]
- Change in Goniometry of wrist and forearm [ Time Frame: Change from baseline to 18 weeks ]
- Change in Grip Dynamometry (% of Unaffected) [ Time Frame: Change from baseline to 18 weeks ]
- Therapy Adherence Log [ Time Frame: up to 18 weeks ]
- Change in Circumferential Edema measurements of 2nd and 3rd digits [ Time Frame: Change from baseline to 18 weeks ]
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| Ages Eligible for Study: | 55 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
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
| Contact: Corey W McGee, PhD | 952-607-6387 | mcge0062@umn.edu | |
| Contact: Virginia O'Brien, OTD | 612-273-7100 | VOBRIEN1@Fairview.org |
| 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 | |
| Principal Investigator: | Corey W McGee, PhD | University of Minnesota, Program in Occupational Therapy |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | University of Minnesota |
| ClinicalTrials.gov Identifier: | NCT02957240 |
| Other Study ID Numbers: |
OT-2016-24458 |
| First Posted: | November 6, 2016 Key Record Dates |
| Last Update Posted: | January 24, 2022 |
| Last Verified: | January 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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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] |
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Musculoskeletal Pain Complex Regional Pain Syndromes Reflex Sympathetic Dystrophy Fractures, Bone Radius Fractures Fractures, Closed Wounds and Injuries Muscular Diseases Musculoskeletal Diseases |
Pain Neurologic Manifestations Forearm Injuries Arm Injuries Autonomic Nervous System Diseases Nervous System Diseases Peripheral Nervous System Diseases Neuromuscular Diseases |