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

Study Status: Suspended
Recruit Status: Unknown status
Study Type: Interventional

Official Title: The PACT Trial - PAtient Centered Telerehabilitation: Effectiveness of Software-supported and Traditional Mirror Therapy in Patients With Phantom Limb Pain Following Lower

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 Summary:

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.


Sponsor: Zuyd University of Applied Sciences

Current Primary Outcome:

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


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: Zuyd University of Applied Sciences

Dates:
Date Received: February 3, 2014
Date Started: May 2014
Date Completion: December 2015
Last Updated: February 27, 2014
Last Verified: February 2014