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Behavioral Intervention

Graded Motor Imagery for Complex Regional Pain Syndrome Prevention After Wrist Fracture

N/A

Recruiting

Led By Corey W McGee, PhD

Research Sponsored by University of Minnesota

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 18 weeks

Awards & highlights

Study Summary

This trial will test whether graded motor imagery can help prevent complex regional pain syndrome, a painful condition that can develop after a forearm fracture.

Who is the study for?

This trial is for women aged 55 or older who have had a non-surgical treatment for a distal radius fracture (a type of broken wrist). They must speak English and not have any central nervous system disorders, other injuries to the same arm, cognitive issues that would prevent them from following instructions, or painful conditions in the opposite arm.Check my eligibility

What is being tested?

The study is testing Graded Motor Imagery (GMI), which includes motor imagery and mirror therapy. It's compared with standard care to see if it can improve pain management and movement outcomes after a wrist fracture. The goal is also to prevent Complex Regional Pain Syndrome (CRPS), which can develop after such fractures.See study design

What are the potential side effects?

There are generally no severe side effects associated with GMI as it involves mental exercises and mirror therapy. However, participants may experience discomfort or frustration if they find the tasks challenging or do not notice immediate improvements.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am a woman over 55 and have had treatment for a wrist fracture.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 18 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~18 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Assessment of Veldman CRPS Type I Diagnostic Criteria

Change in Patient Rated Wrist Evaluation (PRWE) Scores

Change in The McGill Pain Scale - Short Form(SF-MPQ) Scores

Secondary outcome measures

Change in Circumferential Edema measurements of 2nd and 3rd digits

Change in Goniometry of wrist and forearm

Change in Grip Dynamometry (% of Unaffected)

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Standard Care and Motor Representation TechniquesExperimental Treatment2 Interventions

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.

Group II: Standard CareActive Control1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Standard Care

2018

Completed Phase 4

~3720

0 / 1Eligibility criteria met