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Treatment of Phantom Limb Pain by Intensive Visual Simulation Therapy

NCT06483035 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2025-03-21

No results posted yet for this study

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.

Conditions

  • Phantom Limb Pain

Interventions

DEVICE

Intensive Visual Simulation (IVS)

The IVS system initially makes a video-recording of the intact body part (arm or leg) executing a set of specific movements. These video recordings will be digitally reversed and projected onto a large screen in front of the patient. On the screen, the patient will monitor an intact, life-like extremity in place of the amputated extremity. This digital extremity will then execute the recorded movements in a pre-planned manner. Simultaneously, the patient will follow the digital virtual limb moving on the screen with his/hers amputated arm/leg, which is hidden below the screen. Hence, IVS therapy comprises elements of both movement perception, motor planning, motor execution and visual feedback of two intact limbs moving which are distinctive from classical Mirror-Therapy.

OTHER

Usual Care (UC)

After allocation to UC, the participants continue with their normal treatment as prescribed by their medical doctor or other health professionals. All control participants are offered to complete IVS treatment after the end of the study period. The participants in the control group will therefore be placed on a fictitious "waiting list" during the study period.

Sponsors & Collaborators

  • Oslo Metropolitan University

    lead OTHER

Principal Investigators

  • Terje Gjøvaag, PhD · Oslo Metropolitan University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-05
Primary Completion
2026-09-30
Completion
2026-10-31

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06483035 on ClinicalTrials.gov