search
Back to results

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

Primary Purpose

Musculoskeletal Pain, Fractures, Closed, Distal Radius Fracture

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard Care
Motor Representation Techniques
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Musculoskeletal Pain focused on measuring 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]

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Minnesota Program in Occupational TherapyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard Care

Standard Care and Motor Representation Techniques

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in The McGill Pain Scale - Short Form(SF-MPQ) Scores
Change in Patient Rated Wrist Evaluation (PRWE) Scores
Assessment of Veldman CRPS Type I Diagnostic Criteria

Secondary Outcome Measures

Change in joint position sense goniometry of wrist and forearm
Change in Goniometry of wrist and forearm
Change in Grip Dynamometry (% of Unaffected)
Therapy Adherence Log
Change in Circumferential Edema measurements of 2nd and 3rd digits

Full Information

First Posted
October 25, 2016
Last Updated
February 7, 2023
Sponsor
University of Minnesota
Collaborators
American Hand Therapy Foundation, Fairview Health Services
search

1. Study Identification

Unique Protocol Identification Number
NCT02957240
Brief Title
Graded Motor Imagery for Women at Risk for Developing Type I CRPS Following Closed Treatment of Distal Radius Fractures
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
Collaborators
American Hand Therapy Foundation, Fairview Health Services

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Musculoskeletal Pain, Fractures, Closed, Distal Radius Fracture, Complex Regional Pain Syndromes
Keywords
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]

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard Care
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Standard Care and Motor Representation Techniques
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standard Care
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Motor Representation Techniques
Intervention Description
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 Measure Information:
Title
Change in The McGill Pain Scale - Short Form(SF-MPQ) Scores
Time Frame
Change from baseline to 18 weeks
Title
Change in Patient Rated Wrist Evaluation (PRWE) Scores
Time Frame
Change from baseline to 18 weeks
Title
Assessment of Veldman CRPS Type I Diagnostic Criteria
Time Frame
18 weeks
Secondary Outcome Measure Information:
Title
Change in joint position sense goniometry of wrist and forearm
Time Frame
Change from baseline to 18 weeks
Title
Change in Goniometry of wrist and forearm
Time Frame
Change from baseline to 18 weeks
Title
Change in Grip Dynamometry (% of Unaffected)
Time Frame
Change from baseline to 18 weeks
Title
Therapy Adherence Log
Time Frame
up to 18 weeks
Title
Change in Circumferential Edema measurements of 2nd and 3rd digits
Time Frame
Change from baseline to 18 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Corey W McGee, PhD
Phone
952-607-6387
Email
mcge0062@umn.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Virginia O'Brien, OTD
Phone
612-273-7100
Email
VOBRIEN1@Fairview.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Corey W McGee, PhD
Organizational Affiliation
University of Minnesota, Program in Occupational Therapy
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota Program in Occupational Therapy
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Corey McGee, PhD
Phone
507-258-8016
Email
mcge0062@umn.edu
First Name & Middle Initial & Last Name & Degree
Corey W McGee, PhD
First Name & Middle Initial & Last Name & Degree
Ann Van Heest, MD
First Name & Middle Initial & Last Name & Degree
Virginia O'Brien, OTD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
8105263
Citation
Veldman PH, Reynen HM, Arntz IE, Goris RJ. Signs and symptoms of reflex sympathetic dystrophy: prospective study of 829 patients. Lancet. 1993 Oct 23;342(8878):1012-6. doi: 10.1016/0140-6736(93)92877-v.
Results Reference
background
PubMed Identifier
3670870
Citation
Melzack R. The short-form McGill Pain Questionnaire. Pain. 1987 Aug;30(2):191-197. doi: 10.1016/0304-3959(87)91074-8.
Results Reference
background
PubMed Identifier
15109523
Citation
Moseley GL. Graded motor imagery is effective for long-standing complex regional pain syndrome: a randomised controlled trial. Pain. 2004 Mar;108(1-2):192-8. doi: 10.1016/j.pain.2004.01.006.
Results Reference
background
PubMed Identifier
22436440
Citation
Lagueux E, Charest J, Lefrancois-Caron E, Mauger ME, Mercier E, Savard K, Tousignant-Laflamme Y. Modified graded motor imagery for complex regional pain syndrome type 1 of the upper extremity in the acute phase: a patient series. Int J Rehabil Res. 2012 Jun;35(2):138-45. doi: 10.1097/MRR.0b013e3283527d29.
Results Reference
background
PubMed Identifier
8343873
Citation
King TI 2nd. Circumferential finger measurements utilizing a torque meter to increase reliability. J Hand Ther. 1993 Jan-Mar;6(1):35-6. doi: 10.1016/s0894-1130(12)80179-7.
Results Reference
background
PubMed Identifier
26040969
Citation
Walenkamp MM, de Muinck Keizer RJ, Goslings JC, Vos LM, Rosenwasser MP, Schep NW. The Minimum Clinically Important Difference of the Patient-rated Wrist Evaluation Score for Patients With Distal Radius Fractures. Clin Orthop Relat Res. 2015 Oct;473(10):3235-41. doi: 10.1007/s11999-015-4376-9. Epub 2015 Jun 4. Erratum In: Clin Orthop Relat Res. 2015 Sep;473(9):3063.
Results Reference
background
PubMed Identifier
24519331
Citation
Frenkel MO, Herzig DS, Gebhard F, Mayer J, Becker C, Einsiedel T. Mental practice maintains range of motion despite forearm immobilization: a pilot study in healthy persons. J Rehabil Med. 2014 Mar;46(3):225-32. doi: 10.2340/16501977-1263.
Results Reference
background
PubMed Identifier
23628557
Citation
Karagiannopoulos C, Sitler M, Michlovitz S, Tierney R. A descriptive study on wrist and hand sensori-motor impairment and function following distal radius fracture intervention. J Hand Ther. 2013 Jul-Sep;26(3):204-14; quiz 215. doi: 10.1016/j.jht.2013.03.004. Epub 2013 Apr 28.
Results Reference
background
PubMed Identifier
9840793
Citation
MacDermid JC, Turgeon T, Richards RS, Beadle M, Roth JH. Patient rating of wrist pain and disability: a reliable and valid measurement tool. J Orthop Trauma. 1998 Nov-Dec;12(8):577-86. doi: 10.1097/00005131-199811000-00009.
Results Reference
background
PubMed Identifier
29940926
Citation
McGee C, Skye J, Van Heest A. Graded motor imagery for women at risk for developing type I CRPS following closed treatment of distal radius fractures: a randomized comparative effectiveness trial protocol. BMC Musculoskelet Disord. 2018 Jun 26;19(1):202. doi: 10.1186/s12891-018-2115-6.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs