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

NCT02957240 | Completed

• 1 other identifier: OT-2016-24458
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

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]

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• 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

Study Arms (2)

Standard Care

ACTIVE COMPARATOR

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

Standard Care and Motor Representation Techniques

EXPERIMENTAL

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; Behavioral: Motor Representation Techniques

Interventions

Standard Care BEHAVIORAL

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.

Standard Care; Standard Care and Motor Representation Techniques

Motor Representation Techniques BEHAVIORAL

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.

Standard Care and Motor Representation Techniques

Eligibility Criteria

• Age: 55 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead
• American Hand Therapy Foundation: collaborator
• Fairview Health Services: collaborator

Study Sites (1)

University of Minnesota Program in Occupational Therapy

Minneapolis, Minnesota, 55455, United States

Location

Related Publications (10)

• 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.

  PMID: 8105263 BACKGROUND

• Melzack R. The short-form McGill Pain Questionnaire. Pain. 1987 Aug;30(2):191-197. doi: 10.1016/0304-3959(87)91074-8.

  PMID: 3670870 BACKGROUND

• 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.

  PMID: 15109523 BACKGROUND

• 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.

  PMID: 22436440 BACKGROUND

• 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.

  PMID: 8343873 BACKGROUND

• 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.

  PMID: 26040969 BACKGROUND

• 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.

  PMID: 24519331 BACKGROUND

• 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.

  PMID: 23628557 BACKGROUND

• 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.

  PMID: 9840793 BACKGROUND

• 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.

  PMID: 29940926 DERIVED

MeSH Terms

Conditions

Musculoskeletal Pain; Fractures, Closed; Wrist Fractures; Complex Regional Pain Syndromes

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Fractures, Bone; Wounds and Injuries; Wrist Injuries; Arm Injuries; Autonomic Nervous System Diseases; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Corey W McGee, PhD

  University of Minnesota, Program in Occupational Therapy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2016
• First Posted: November 7, 2016
• Study Start: October 1, 2018
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: August 21, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)