About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Significant visual impairment / blind

Unable to follow instructions, i.e significant cognitive impairment.

Trial design

Design model

Parallel

Treatments tested in this trial

Intensive Visual Simulation (IVS)
Device
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.
Usual Care (UC)
Other intervention
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.

Treatment groups

38 Participants

are divided into 2 treatment groups

Group A: Intensive Visual Simulation (IVS)Experimental treatment 1 intervention

Group B: Usual CareActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Phantom limb pain intensity- 14 day pain dairy

Phantom pain intensity is measured once a day for 14 days using a 14-day pain diary with VAS scales ranging for 0-10 cm. A score of 0 indicating no pain and a score of 10 indicating extreme pain. The participants will be given a paper form with 14 VAS scales (one for each day) three times during the study period: 14 days before the first treatment, following the last treatment and at 2 months follow-up. Every day during the 14 days, the participants indicate the current phantom pain level on the VAS scale. An average of the 14 pain measurements is then calculated and used as a measure of the participant\'s \"phantom pain intensity\". In addition the highest value recorded during this period will be reported A 14-day diary is selected instead of one retrospective VAS measurement to reduce the risk of memory bias.

Time frame

Measured at Baseline (0 months), at the end of Intervention (2 months after Baseline) and at the end of Follow-up (4 months after Baseline)

Secondary outcomes

1

Health related quality of life

European Quality of life 5 dimensions 5 level questionnaire (EQ-5D-5L) For the 5 dimensions (5D) the EQ-5D-5L asks the participants to rate their ability for each domain (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), respectively on a 1-5 Level Scale (5L), a score of 1 indicating no problems, and a score of 5 indicating extreme problems. The EQ-VAS asks the participant to rate their overall health 'today' on a 0-100 VAS. A higher score indicates a better quality of life. The SF-36 questionnaire complements the EQ-5D-5L questionnaire.

Time frame