Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06483035

Treatment of Phantom Limb Pain by Intensive Visual Simulation Therapy

Led by Oslo Metropolitan University · Updated on 2025-03-21

38

Participants Needed

1

Research Sites

108 weeks

Total Duration

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AI-Summary

What this Trial Is About

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

Official Title

Treatment of Phantom Limb Pain by Intensive Visual Simulation Therapy

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults over 18 years old
  • Unilateral or bilateral upper or lower limb amputation
  • At least 12 months have passed since amputation
  • Chronic phantom limb pain lasting more than 6 months
  • Phantom limb pain intensity greater than 3 on a 0-10 pain scale
  • Analgesic treatments have been stable for at least the past month
  • Stable prosthetic fit or not using a prosthesis
  • Adequate Norwegian language skills
Not Eligible

You will not qualify if you...

  • Significant visual impairment or blindness
  • Unable to follow instructions due to cognitive impairment

AI-Screening

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Trial Site Locations

Total: 1 location

1

Oslo Metropolitan University

Oslo, Norway, 0130

Actively Recruiting

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Research Team

J

Jens-Christian Trojel Hviid, MSci

CONTACT

T

Terje Gjøvaag, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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