Telerehabilitation Using Mirror Therapy in Patients With Phantom Limb Pain Following Lower Limb Amputation.

The PACT Trial - PAtient Centered Telerehabilitation: Effectiveness of Software-supported and Traditional Mirror Therapy in Patients With Phantom Limb Pain Following Lower Limb Amputation: Design of a Randomized Controlled Trial.

The overall aim of this randomized controlled study is to investigate the effectiveness of mirror therapy supported by telerehabilitation on the intensity, duration and frequency of phantom limb pain and daily activities compared to traditional mirror therapy and sensomotor exercises without a mirror in patients following lower limb amputation.

Study Overview

• Status: Unknown
• Conditions: Phantom Limb Pain
• Intervention / Treatment: Other: Physical/Occupational therapy

Detailed Description

Up to 75% of patients after amputation of an arm or leg suffer from chronic phantom limb pain that still is perceived in the missing limb, leading to limitations in daily activities and quality of life. The treatment of phantom limb pain is still challenging. Despite many different pharmacological interventions, the outcomes on the longer-term are in many cases not satisfying. Alternative, non-pharmacological interventions, such as mirror therapy, are gaining increased recognition in the treatment of phantom limb pain. In this context, telerehabilitation plays an important role to support long-term self-management and autonomy of these patients.

In the developmental phase of the project, a user-centred design is applied. Patients as well as physical and occupational therapists are interviewed concerning their preferences and needs with respect to the design and content of the telerehabilitation. Additionally, two focus groups with each five participants will be conducted. Subsequently, a prototype of the telerehabilitation will be developed based on user preferences, available evidence, expert opinion and already existing systems. This prototype will be tested on its usability and technical performance in phase three using the thinking-aloud-method and data logging. Accordingly, a multicenter, randomized controlled trial will be conducted to evaluate the cost-effectiveness of the telerehabilitation.

• Study Type: Interventional
• Enrollment (Anticipated): 105
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Lower limb amputation
2. At least since one week constant or intermittent phantom limb pain (PLP) with an average intensity of at least score 3 on the 11-point NRS and a minimum frequency of one episode of PLP per week.

3. Sufficient cognitive, communicative and motor functions to be able to use the telerehabilitation service, to concentrate for at least 15 minutes on the mirror image and to follow instructions and questionnaires; this is based on clinical judgment of recruiting physicians or therapists.

   Exclusion Criteria:

4. Duration of inpatient rehabilitation not long enough to ensure the 4-week clinical intervention phase.
5. Bilateral amputation, severe co-morbidity (e.g. stroke) or pain affecting the intact limb; this prevents engagement in the prescribed exercise programs of the study.
6. Severe psychiatric disorders that preclude patients from participating in the trial.
7. Intensive course of mirror therapy in the past (> 6 treatments during the last three months).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Software Supported Mirror Therapy; First experimental condition Physical/Occupational Therapy	Other: Physical/Occupational therapy; At least 10 individual sessions over the clinical intervention period of 4 weeks followed by a 6 weeks self-management phase.
Experimental: Traditional mirror therapy; Second experimental condition Physical/Occupational Therapy	Other: Physical/Occupational therapy; At least 10 individual sessions over the clinical intervention period of 4 weeks followed by a 6 weeks self-management phase.
Active Comparator: Sensomotor exercises without mirror; Control condition Physical/Occupational Therapy	Other: Physical/Occupational therapy; At least 10 individual sessions over the clinical intervention period of 4 weeks followed by a 6 weeks self-management phase.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in average intensity of phantom limb pain	Measurement instrument: 11-point NRS	At baseline, 4 and 6 weeks following baseline and at 6 months follow-up
Change in frequency of phantom limb pain		At baseline, 4 and 6 weeks following baseline and at 6 months follow-up
Change in duration of phantom limb pain		At baseline, 4 and 6 weeks following baseline and at 6 months follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in pain related limitations in daily activities	Measurement instrument: PDI, PSFS	At baseline, 4 and 6 weeks following baseline and at 6 months follow-up
Change in pain specific self-efficacy	Measurement instrument: Pain specific self-efficacy scale	At baseline, 4 and 6 weeks following baseline and at 6 months follow-up
Change in quality of life	Measurement instrument: EQ-5D-5L	At baseline, 4 and 6 weeks following baseline and at 6 months follow-up
Change in global perceived effect	Measurement instrument: GPE scale	At baseline, 4 and 6 weeks following baseline and at 6 months follow-up
Change in dimensions of phantom limb pain	Measurement instrument: Neuropathic Pain Symptom Inventory (NPSI)	At baseline, 4 and 6 weeks following baseline and at 6 months follow-up

Collaborators and Investigators

• Sponsor: Zuyd University of Applied Sciences
• Collaborators: Maastricht University
• Investigators: Study Director: Rob J Smeets, Prof., Dr., Research School CAPHRI, Maastricht University, Maastricht, The Netherlands

Publications and helpful links

General Publications

• Rothgangel AS, Braun S, Schulz RJ, Kraemer M, de Witte L, Beurskens A, Smeets RJ. The PACT trial: PAtient Centered Telerehabilitation: effectiveness of software-supported and traditional mirror therapy in patients with phantom limb pain following lower limb amputation: protocol of a multicentre randomised controlled trial. J Physiother. 2015 Jan;61(1):42; discussion 42. doi: 10.1016/j.jphys.2014.08.006. Epub 2014 Oct 16.

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Anticipated): May 1, 2015
• Study Completion (Anticipated): December 1, 2015

Study Registration Dates

• First Submitted: February 3, 2014
• First Submitted That Met QC Criteria: February 27, 2014
• First Posted (Estimate): March 3, 2014

Study Record Updates

• Last Update Posted (Estimate): March 3, 2014
• Last Update Submitted That Met QC Criteria: February 27, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Keywords: Telerehabilitation, mirror therapy, phantom limb pain
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Postoperative Complications; Pain; Neurologic Manifestations; Neurobehavioral Manifestations; Perceptual Disorders; Pain, Postoperative; Phantom Limb
• Other Study ID Numbers: 005-GW02-035