Treatment for phantom limb pain using visual simulation therapy
Intensive Visual Simulation as Treatment for Chronic Phantom Limb Pain in Persons With Upper or Lower Limb Amputation - A Randomized Controlled Trial
This study is testing if a new therapy using visual simulations can help amputees with phantom limb pain feel less discomfort compared to standard care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 38 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Oslo Metropolitan University Academic / other |
| Locations | 1 site (Oslo) |
| Trial ID | NCT06483035 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of Intensive Visual Simulation Therapy (IVS-T) in reducing phantom limb pain (PLP) compared to usual care. PLP affects a significant number of amputees, causing severe discomfort and impacting quality of life. The study employs a randomized controlled trial design, enrolling participants who have experienced unilateral or bilateral limb amputation and have chronic PLP for at least six months. The primary goal is to determine if IVS-T can significantly lower pain intensity after two months of treatment.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old who have experienced unilateral or bilateral limb amputation and have chronic phantom limb pain.
Not a fit: Patients with significant visual impairments or cognitive impairments that prevent them from following instructions may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could provide a non-invasive and effective treatment option for patients suffering from phantom limb pain.
How similar studies have performed: While pilot studies have shown promising results for IVS-T, this approach is relatively novel and lacks extensive randomized controlled trial evidence.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Oslo
- Oslo Metropolitan University — Oslo, Norway (Recruiting)
Study contacts
- Principal investigator: Terje Gjøvaag, PhD — Oslo Metropolitan University
- Study coordinator: Jens-Christian Trojel Hviid, MSci
- Email: jehvi7741@oslomet.no
- Phone: +4794449140
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.