Treatment of Phantom Limb Pain by Intensive Visual Simulation Therapy

Recruiting now · Not applicable

Conditions studied: Phantom Limb Pain

In brief

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.

Key facts

Study ID

NCT06483035

Run by

Oslo Metropolitan University

People needed

38

Starts

2024-09-05

Expected to finish

2026-10-01

Last updated by the study team

2025-03-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Significant visual impairment / blind
• Unable to follow instructions, i.e significant cognitive impairment.

Where it is running

• Oslo Metropolitan University — Oslo, Norway (enrolling)

Full record on ClinicalTrials.gov

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