Clinical trial NCT02076490: Telerehabilitation Using Mirror Therapy in Patients With Phantom Limb Pain Following Lower Limb Amputation.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Phantom Limb Pain
Keywords: Telerehabilitation, mirror therapy, phantom limb pain
Lead sponsor: Zuyd University of Applied Sciences
Sponsor class: OTHER
Collaborators: name: Maastricht University
First posted: 2014-03-03
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Change in average intensity of phantom limb pain
timeFrame: At baseline, 4 and 6 weeks following baseline and at 6 months follow-up
measure: Change in frequency of phantom limb pain
timeFrame: At baseline, 4 and 6 weeks following baseline and at 6 months follow-up
measure: Change in duration of phantom limb pain
timeFrame: At baseline, 4 and 6 weeks following baseline and at 6 months follow-up
Secondary outcomes:
measure: Change in pain related limitations in daily activities
timeFrame: At baseline, 4 and 6 weeks following baseline and at 6 months follow-up
measure: Change in pain specific self-efficacy
timeFrame: At baseline, 4 and 6 weeks following baseline and at 6 months follow-up
measure: Change in quality of life
timeFrame: At baseline, 4 and 6 weeks following baseline and at 6 months follow-up
measure: Change in global perceived effect
timeFrame: At baseline, 4 and 6 weeks following baseline and at 6 months follow-up
measure: Change in dimensions of phantom limb pain
timeFrame: At baseline, 4 and 6 weeks following baseline and at 6 months follow-up
Other outcomes:
Locations:
Study officials:
affiliation: Research School CAPHRI, Maastricht University, Maastricht, The Netherlands
name: Rob J Smeets, Prof., Dr.
role: STUDY_DIRECTOR
References:
citation: 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.