Treatment of Phantom Limb Pain by Intensive Visual Simulation Therapy

NCT06483035 | Recruiting DMC

• 1 other identifier: 715760
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Amputation; Chronic pain; Intensive Visual Stimulation; RCT

Outcome Measures

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.

  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 (6)

• Health related quality of life

  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

  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

  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

  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)

  During 2nd week and 8th week of IVS treatment

Other Outcomes (10)

• Quality of Life (QoL)

  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

  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

  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

Study Arms (2)

Intensive Visual Simulation (IVS)

EXPERIMENTAL

Treatment is performed by an IVS trained physiotherapists. Patients receive maximum 16 treatments over 2 months. In addition, all participants will undergo a baseline, an endpoint and a 2-month follow-up examination conducted by a physiotherapist. The treatment is individually adapted to the level of motor control in the phantom arm/leg and pain level of the individual participant. An IVS treatment session consists of individualized exercises for the phantom arm/phantom leg with appropriate progression and adjustments. In addition to IVS, all participants in the experimental group continues their routine medical care

Device: Intensive Visual Simulation (IVS)

Usual Care

ACTIVE COMPARATOR

All participants randomized to the control group undergo the same baseline and endpoint examinations as the experimental group. This group continues with their routine medical and non-medical care offered by their own doctor or other health professionals during the study period.The participants shall not start mirror therapy or IVS therapy during this period. Following endpoint examination, they are offered to start IVS treatment for a period of 8 weeks. After IVS treatment there is a 8 week follow up period.

Other: Usual Care (UC)

Interventions

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.

Intensive Visual Simulation (IVS)

Usual Care (UC) OTHER

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.

Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Oslo Metropolitan University: lead

Study Sites (1)

Oslo Metropolitan University

Oslo, 0130, Norway

RECRUITING

MeSH Terms

Conditions

Phantom Limb; Chronic Pain

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain

Study Officials

• Terje Gjøvaag, PhD

  Oslo Metropolitan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jens-Christian Trojel Hviid, MSci

CONTACT

+4794449140; jehvi7741@oslomet.no

Terje Gjøvaag, PhD

CONTACT

+4795866979; terje@oslomet.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is a 2-arm randomized controlled trial with a parallel group design. If persons first allocated to Waiting list/Usual Care and then secondly to IVS treatment, are similar to those persons receiveing IVS treatment as the first treatment, a semi-crossover study design will be considered

Study Record Dates

• First Submitted: June 12, 2024
• First Posted: July 1, 2024
• Study Start: September 5, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: March 21, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)