Clinical trial NCT02957240: 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
Overall status: COMPLETED
Phase: NA
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]
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: American Hand Therapy Foundation
name: Fairview Health Services
First posted: 2016-11-06
Enrollment: 15
Sex: FEMALE
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Change in The McGill Pain Scale - Short Form(SF-MPQ) Scores
timeFrame: Change from baseline to 18 weeks
measure: Change in Patient Rated Wrist Evaluation (PRWE) Scores
timeFrame: Change from baseline to 18 weeks
measure: Assessment of Veldman CRPS Type I Diagnostic Criteria
timeFrame: 18 weeks
Secondary outcomes:
measure: Change in joint position sense goniometry of wrist and forearm
timeFrame: Change from baseline to 18 weeks
measure: Change in Goniometry of wrist and forearm
timeFrame: Change from baseline to 18 weeks
measure: Change in Grip Dynamometry (% of Unaffected)
timeFrame: Change from baseline to 18 weeks
measure: Therapy Adherence Log
timeFrame: up to 18 weeks
measure: Change in Circumferential Edema measurements of 2nd and 3rd digits
timeFrame: Change from baseline to 18 weeks
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota Program in Occupational Therapy
state: Minnesota
Study officials:
affiliation: University of Minnesota, Program in Occupational Therapy
name: Corey W McGee, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: Melzack R. The short-form McGill Pain Questionnaire. Pain. 1987 Aug;30(2):191-197. doi: 10.1016/0304-3959(87)91074-8.
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.
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.
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.
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.
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.
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.
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.
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.