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

Phantom Limb Pain Clinical Trial

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.

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02076490
• Other study ID #: 005-GW02-035
• Status: Enrolling by invitation
• Phase: N/A
• First received: February 3, 2014
• Last updated: February 27, 2014
• Start date: May 2014
• Est. completion date: December 2015

Study information

• Verified date: February 2014
• Source: Zuyd University of Applied Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 105
• Est. completion date: December 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Phantom Limb
• Phantom Limb Pain

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Zuyd University of Applied Sciences	Maastricht University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Change in frequency of phantom limb pain		At baseline, 4 and 6 weeks following baseline and at 6 months follow-up	No
Primary	Change in duration of phantom limb pain		At baseline, 4 and 6 weeks following baseline and at 6 months follow-up	No
Secondary	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	No
Secondary	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	No
Secondary	Change in quality of life	Measurement instrument: EQ-5D-5L	At baseline, 4 and 6 weeks following baseline and at 6 months follow-up	No
Secondary	Change in global perceived effect	Measurement instrument: GPE scale	At baseline, 4 and 6 weeks following baseline and at 6 months follow-up	No
Secondary	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	No

External Links

•   Study homepage