Treatment of Phantom Limb Pain by Intensive Visual Simulation Therapy
RecruitingNot applicableNCT06483035
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Intensive Visual Simulation as Treatment for Chronic Phantom Limb Pain in Persons With Upper or Lower Limb Amputation - A Randomized Controlled Trial
- Conditions
- Interventions
- Device: Intensive Visual Simulation (IVS)
- Other: Usual Care (UC)
- Sponsor
- Oslo Metropolitan University
- Start date
- 2024-09-05
- Primary completion
- 2026-09
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- Norway
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * 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 Exclusion Criteria: * Significant visual impairment / blind * Unable to follow instructions, i.e significant cognitive impairment.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT06483035