Treatment of Phantom Limb Pain by Intensive Visual Stimulation Therapy
NCT Number: NCT06483035
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Phantom Limb Pain
Interventions: DEVICE: Intensive Visual Stimulation (IVS)|OTHER: Usual Care (UC)
Sponsor: Oslo Metropolitan University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 38
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2026-10

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 Stimulation 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.

Primary Outcome Measures: 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".

A 14-day diary is selected instead of one retrospective VAS measurement to reduce the risk of memory bias., 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 Outcome Measures: 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., Assessed at 0 months (Baseline), immediately at the end of intervention (2 months) and immediately at the end of follow-up (4 months)|Pain characteristics, Measured by the Short-Form McGill Pain Questionnaire (SF-MPQ). This is a multidimensional validated measuring instrument for pain that measures both sensory, affective, and other qualitative pain characteristics in addition to pain intensity. The questionnaire consists of 15 descriptive words of either sensory (11 items) or affective (4 items) qualities with 1-3 scoring. A score of 1 meaning "none" and a score of 3 meaning "severe". In addition, there is a VAS 0-10 scale for an average pain level, and a 0 (no pain) to 5 (excruciating) scale for pain level (today)., Assessed at 0 months (Baseline), immediately at the end of intervention (2 months) and immediately at the end of follow-up (4 months)|Upper Extremity Function, Measured by the Orthotic and Prosthetic User Survey (OPUS) Upper Extremity Functional scale (OPUS-UEFS) Questionnaire for measuring upper extremity function. The form investigates the degree of difficulty (1-5 scale) in performing 28 different functional activities of daily living (e.g. washing the face). A score of 1 indicating "very easy", and a score of 5 indicating "cannot do this activity" The questionnaire will be used on people with upper limb amputation., Assessed at 0 months (Baseline), immediately at the end of intervention (2 months) and immediately at the end of follow-up (4 months)|Lower Extremity Function, Measured by the OPUS Lower Extremity Functional Scale (OPUS-LEFS) Questionnaire for measuring lower extremity function. The form investigates the degree of difficulty (1-5 scale) in performing 20 different functional activities of daily living (e.g. getting in and out of the shower). A score of 1 indicating "very easy", and a score of 5 indicating "cannot do this activity" The questionnaire will be used on people with lower limb amputation., Assessed at 0 months (Baseline), immediately at the end of intervention (2 months) and immediately at the end of follow-up (4 months)|Concentration (micromolar levels) of oxygenated (oxyHb) and deoxygenated (deoxyHb) hemoglobin in specific brain cortical regions of interest (ROIs), Concentration of oxyHb and deoxyHb are measured in the following ROIs: Motor cortex, Supplementary motor area, Pre-motor area and Somatosensory area during IVS with functional near infrared spectroscopy (fNIRS). Participants in the experimental group will undergo testing during two time periods: first, during the estimated second week of treatment following training in the use of the IVS system, and second, during the final week of treatment., During 2nd week and 8th week of IVS treatment|Phantom pain intensity before and after treatment sessions, Measured with a 0-10 cm VAS scale before and after each treatment session., At each session immediately before and after treatment. Each participant will receive a maximum of 16 treatment sessions over a period of eight weeks
Other Outcome Measures: Quality of Life (QoL), Scoring of QoL using the 36 question Short Form (SF-36) questionnaire. This questionnaire covers more dimensions than the EQ-5D-5L questionnaire. Most of the questions are scored on a 1-5 scale with 5 being the better score. Some questions have only yes/no alternatives and some questions have a 1-6 sale, with 1 being the better score., Assessed at 0 months (Baseline), immediately at the end of intervention (2 months) and immediately at the end of follow-up (4 months)|Health Status Score on a VAS scale, Scoring of health state on a Visual Analog Scale (VAS) from 0-10. This score is a part of the EQ-5D-5L questionnaire, Assessed at 0 months (Baseline), immediately at the end of intervention (2 months) and immediately at the end of follow-up (4 months)|Use of analgesics, Use of analgesics (opioids, NSAIDs, Paracetamol, TCA) reported by the patient by a Yes or No answer., The participants use of analgesics is assessed during the last week prior to start of IVS or UC treatment and immediately after eight weeks of IVS or UC treatment|Adverse events, Assessed by asking the patient to report the occurrence of any serious adverse reactions or adverse reactions during the last 2 months., Assessed immediately at the end of intervention (2 months after baseline) and at end of follow-up (4 months after baseline)|Sociodemographic variables, Age, education, job status, location, marital status, etc., Assessed at baseline (0 months)|Cause of amputation, Reason for amputation, e.g. traumatic, vascular, infection, cancer, congenital, or other reason, Assessed at baseline (0 months)|Level of amputation, Above or below elbow-joint for upper extremity amputation Above or below knee-joint for lower extremity amputation, Assessed at baseline (0 months)|Hours of daily prosthetic use, How many hours per day the participants use their prosthesis, Assessed at 0 months (Baseline), immediately at the end of intervention (2 months) and immediately at the end of follow-up (4 months)|Experience of phantom limb sensations, Does the participants experience the "presence" of a phantom limb? Yes or no question, Assessed at 0 months (Baseline), immediately at the end of intervention (2 months) and immediately at the end of follow-up (4 months)|Presence of comorbidities, Do the participants have other medical conditions besides phantom limb pain (PLP)? Participants will be asked during baseline interview if they have or do not have other medical conditions than PLP., Assessed at baseline (0 months)