Intensive Visual Simulation as Treatment for Chronic Phantom Limb Pain in Persons With Upper or Lower Limb Amputation - A Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Other, Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Phantom limb pain (PLP) is reported by as much as 80 % of patients following an amputation. There is increasing knowledge of the relation between PLP and maladaptive changes in brain cortical regions. Research has shown that the sight of an intact arm moving in a mirror may reverse maladaptions (Mirror-therapy, MT) and reduce PLP. The current project will implement a digital and modernized version of MT, i.e. Intensive Visual Simulation Therapy (IVS-T). Pilot studies have shown promising results on pain reduction in people with phantom limb pain when using IVS-T. However, there is a lack of RCT studies on this patient population. This study is a 2-arm randomized controlled trial (RCT) investigating the effectiveness of IVS-T compared with usual care in person with unilateral upper- or lower limb amputation with chronic phantom limb pain. The primary aim of the study is to investigate if IVS treatment is superior to usual care in reducing phantom limb pain intensity after 2 months of treatment in unilateral amputees with moderate to severe PLP. The study will furthermore explore quality of life, analgesic consumption, phantom pain characteristics, mobility, and disability. In addition, the study utilizes brain imagery during treatments to investigate neural plasticity and the association between PLP and maladaptive cortical changes.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Unilateral or bilateral lower limb/upper limb amputees

• Adults \> 18 years of age, no age limit

• A minimum of 12 months since amputation

• Chronic PLP: \> 6 months

• PLP intensity: \> 3 on the 0-10 VAS scale

• Analgesic treatments must have been stable for the previous month

• Stable prosthetic situation (ie, satisfaction with the fitting of the prosthesis) or being a non-user.

• Adequate Norwegian language skills

Locations
Other Locations
Norway
Oslo Metropolitan University
RECRUITING
Oslo
Contact Information
Primary
Jens-Christian Trojel Hviid, MSci
jehvi7741@oslomet.no
+4794449140
Backup
Terje Gjøvaag, PhD
terje@oslomet.no
+4795866979
Time Frame
Start Date: 2024-09-05
Estimated Completion Date: 2026-10
Participants
Target number of participants: 38
Treatments
Experimental: Intensive Visual Simulation (IVS)
Treatment is performed by an IVS trained physiotherapists. Patients receive maximum 16 treatments over 2 months. In addition, all participants will undergo a baseline, an endpoint and a 2-month follow-up examination conducted by a physiotherapist. The treatment is individually adapted to the level of motor control in the phantom arm/leg and pain level of the individual participant.~An IVS treatment session consists of individualized exercises for the phantom arm/phantom leg with appropriate progression and adjustments.~In addition to IVS, all participants in the experimental group continues their routine medical care
Active_comparator: Usual Care
All participants randomized to the control group undergo the same baseline and endpoint examinations as the experimental group. This group continues with their routine medical and non-medical care offered by their own doctor or other health professionals during the study period.The participants shall not start mirror therapy or IVS therapy during this period. Following endpoint examination, they are offered to start IVS treatment for a period of 8 weeks. After IVS treatment there is a 8 week follow up period.
Related Therapeutic Areas
Sponsors
Leads: Oslo Metropolitan University

This content was sourced from clinicaltrials.gov