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

Not Applicable

Completed

• Conditions: Fractures, Closed; Musculoskeletal Pain; Distal Radius Fracture; Complex Regional Pain Syndromes
• Interventions: Behavioral: Standard Care; Behavioral: Motor Representation Techniques

• Registration Number: NCT02957240
• Lead Sponsor: University of Minnesota

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.

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 Timeline

• Study First Submitted: 2016-10-25
• Study First Submitted QC: 2016-11-03
• Study First Posted: 2016-11-06
• Study Start: 2018-10-01
• Primary Completion: 2024-06-30
• Study Completion: 2024-06-30
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-20
• Last Update Posted: 2024-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 15

Inclusion Criteria

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Care	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.
Standard Care and Motor Representation Techniques	Standard Care	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.
Standard Care and Motor Representation Techniques	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Minnesota Program in Occupational Therapy; 🇺🇸 Minneapolis, Minnesota, United States