NCT06483035 Treatment of Phantom Limb Pain by Intensive Visual Simulation Therapy
| NCT ID | NCT06483035 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Oslo Metropolitan University |
| Condition | Phantom Limb Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 38 participants |
| Start Date | 2024-09-05 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 38 participants in total. It began in 2024-09-05 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Terje Gjøvaag, PhD
PRINCIPAL INVESTIGATOR
Oslo Metropolitan University
Frequently Asked Questions
Who can join the NCT06483035 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Phantom Limb Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06483035 currently recruiting?
Yes, NCT06483035 is actively recruiting participants. Contact the research team at jehvi7741@oslomet.no for enrollment information.
Where is the NCT06483035 trial being conducted?
This trial is being conducted at Oslo, Norway.
Who is sponsoring the NCT06483035 clinical trial?
NCT06483035 is sponsored by Oslo Metropolitan University. The principal investigator is Terje Gjøvaag, PhD at Oslo Metropolitan University. The trial plans to enroll 38 participants.