TITAN Trial: Reducing Phantom Limb Pain in People with Amputations

Neuroscience Research Australia208 enrolled

Overview

The goal of this clinical trial is to investigate the effectiveness of two rehabilitation programs for individuals who have undergone amputations and are experiencing phantom limb pain. The main question it aims to answer is: \- In individuals who have undergone amputations and are experiencing phantom limb pain, what is the effectiveness of a progressive rehabilitation program compared to a treatment program consisting of transcutaneous electrical nerve stimulation and cranial electrical stimulation on reducing pain intensity and pain interference? A total of 208 participants will be randomized into two groups: progressive rehabilitation program and stimulation devices. The progressive rehabilitation program includes pain science education, sensory training, and left/right judgements, imagined movements and mirror therapy. The treatment program for the group receiving the stimulation devices includes transcutaneous electrical nerve stimulation and cranial electrical stimulation. Both interventions will be delivered via eight, up to 1-hour telehealth sessions. Outcome measures will be assessed at baseline and weeks 12, 24 and 52.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

208

Conditions

Phantom Limb Pain Amputation

Interventions

Progressive rehabilitation programOTHER

Twelve-week treatment program delivered via eight, up to 1-hour telehealth sessions. The first five sessions will be scheduled every week, and the final three sessions will be scheduled fortnightly. Participants will also be prescribed approximately 15-30 minutes of home activities daily. The treatment program includes pain science education, sensory training, implicit and explicit motor imagery, and mirror therapy. Participants will complete activities at a self-directed pace following a standard progression protocol. Participant adherence will be measured via session attendance and self-report therapy diaries.

Stimulation devicesOTHER

Twelve-week treatment program delivered via eight, up to 1-hour telehealth sessions. The first five sessions will be scheduled every week, and the final three sessions will be scheduled fortnightly. Participants will also be prescribed approximately 15-30 minutes of home activities daily. The treatment program includes transcutaneous electrical nerve stimulation and cranial electrical stimulation. Participants will complete activities at a self-directed pace following a standard progression protocol. Participant adherence will be measured via session attendance and self-report therapy diaries.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Experiencing phantom limb pain for at least three months. * Report at least one episode of phantom limb pain in the previous week. * Report at least 4 points in pain intensity over the previous 7 days, assessed using the 11-point Numerical Pain Rating Scale. * Be a resident in Australia for the intervention and follow-up period. * Have access to the internet and smart device (e.g., mobile phone). * Be proficient in English. Exclusion Criteria: * Bilateral amputation. * Scheduled for major surgery during the study period. * Pain in the intact limb. * Vision impairment that would preclude successful participation. * Auditory impairment that would preclude successful participation. * Cognitive problems that would preclude effective participation in trial procedures (e.g., Alzheimer's, dementia). * Previously diagnosed neurological disorders that affect the movement of the intact limb (e.g., stroke, Parkinson, Multiple Sclerosis). * Completed Graded Motor Imagery in the order of left/right judgements, imagined movements, and mirror therapy. * Have contraindications for the use of stimulation devices (e.g., pacemaker, spinal cord stimulator).

Outcomes

Primary Outcomes

Pain intensity

Average pain intensity over the previous 7 days assessed using the 11-point Numerical Pain Rating Scale.

Time frame: Week 12 post-randomisation

Pain interference

Average pain interference with function over the previous 7 days assessed using the 0-10 Pain Interference Scale of the Brief Pain Inventory.

Time frame: Week 12 post-randomisation

Secondary Outcomes

Pain intensity

Average pain intensity over the previous 7 days assessed using the 11-point Numerical Pain Rating Scale.

Time frame: Weeks 24 and 52 post-randomisation

Pain interference

Average pain interference with function over the previous 7 days assessed using the 0-10 Pain Interference Scale of the Brief Pain Inventory.

Time frame: Weeks 24 and 52 post-randomisation

Pain severity

Average pain intensity over the previous 7 days assessed using the 0-10 Pain Severity Scale of the Brief Pain Inventory.

Time frame: Weeks 12, 24 and 52 post-randomisation

Sleep subscale of the Brief Pain Inventory's Pain Interference Scale

Sleep Quality assessed using the Sleep subscale of the Brief Pain Inventory's Pain Interference Scale. The participants will rate the interference of pain with sleep on a 0-10 scale where "0" represents "does not interfere" and "10" represents "completely interferes".

Time frame: Weeks 12, 24 and 52 post-randomisation

PROMIS Self-Efficacy Manage Symptoms

Pain Self-efficacy assessed using PROMIS Self-Efficacy Manage Symptoms (Computer Adaptive Test) (28-item version; higher scores mean more self-efficacy).

Time frame: Weeks 12, 24 and 52 post-randomisation

PROMIS Depression

Emotional distress and depression assessed using PROMIS Depression (Computer Adaptive Test) (28-item version; higher scores mean more depression).

Time frame: Weeks 12, 24 and 52 post-randomisation

EuroQol 5-Dimension 5-Level (EQ-5D-5L)

Health-Related Quality of Life assessed using the EQ-5D-5L dimensions scale range, 1-5; higher scores indicate better quality of life) and health thermometer (range, 0-100; higher scores indicate better quality of life).

Time frame: Weeks 12, 24 and 52 post-randomisation

Global Perceived Effect Scale

Perception of recovery assessed using the Global Perceived Effect scale (range from -5 to +5; higher scores mean greater improvement).

Time frame: Weeks 12, 24 and 52 post-randomisation

Adverse events

Adverse events assessed via self-report.

Time frame: From randomisation to week 12 post-randomisation

Adherence to treatment

Adherence to treatment assessed via session attendance and self-report (diary), including frequency per week and duration per day.

Time frame: From randomisation to week 12 post-randomisation

Total health-care costs

Total health-care costs will be estimated as the trial intervention costs and outside trial health-care resource use attributable to phantom limb pain from the Medicare Benefits Scheme and Pharmaceutical Benefits Scheme. Quality-adjusted life-years (QALYs) from the EQ-5D-5L using the Australian utility weights will also be used in the trial-based cost-utility analysis.

Time frame: Weeks 12, 24 and 52 post-randomisation

Treatment rationale credibility

Treatment rationale credibility assessed using the Credibility and Expectancy Questionnaire. The total score ranges from 0 to 48, with lower scores indicating lower credibility.

Time frame: Week 1 post-randomisation

TITAN Trial: Reducing Phantom Limb Pain in People with Amputations

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts