Amputation, Phantom Limb Pain
Conditions
Brief summary
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.
Interventions
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.
OTHERStimulation devices
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.
Sponsors
Neuroscience Research Australia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain interference | Week 12 post-randomisation | Average pain interference with function over the previous 7 days assessed using the 0-10 Pain Interference Scale of the Brief Pain Inventory. |
| Pain intensity | Week 12 post-randomisation | Average pain intensity over the previous 7 days assessed using the 11-point Numerical Pain Rating Scale. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain severity | Weeks 12, 24 and 52 post-randomisation | Average pain intensity over the previous 7 days assessed using the 0-10 Pain Severity Scale of the Brief Pain Inventory. |
| Sleep subscale of the Brief Pain Inventory's Pain Interference Scale | Weeks 12, 24 and 52 post-randomisation | 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. |
| PROMIS Self-Efficacy Manage Symptoms | Weeks 12, 24 and 52 post-randomisation | Pain Self-efficacy assessed using PROMIS Self-Efficacy Manage Symptoms (Computer Adaptive Test) (28-item version; higher scores mean more self-efficacy). |
| PROMIS Depression | Weeks 12, 24 and 52 post-randomisation | Emotional distress and depression assessed using PROMIS Depression (Computer Adaptive Test) (28-item version; higher scores mean more depression). |
| EuroQol 5-Dimension 5-Level (EQ-5D-5L) | Weeks 12, 24 and 52 post-randomisation | 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). |
| Global Perceived Effect Scale | Weeks 12, 24 and 52 post-randomisation | Perception of recovery assessed using the Global Perceived Effect scale (range from -5 to +5; higher scores mean greater improvement). |
| Adverse events | From randomisation to week 12 post-randomisation | Adverse events assessed via self-report. |
| Pain intensity | Weeks 24 and 52 post-randomisation | Average pain intensity over the previous 7 days assessed using the 11-point Numerical Pain Rating Scale. |
| Total health-care costs | Weeks 12, 24 and 52 post-randomisation | 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. |
| Treatment rationale credibility | Week 1 post-randomisation | Treatment rationale credibility assessed using the Credibility and Expectancy Questionnaire. The total score ranges from 0 to 48, with lower scores indicating lower credibility. |
| Adherence to treatment | From randomisation to week 12 post-randomisation | Adherence to treatment assessed via session attendance and self-report (diary), including frequency per week and duration per day. |
| Pain interference | Weeks 24 and 52 post-randomisation | Average pain interference with function over the previous 7 days assessed using the 0-10 Pain Interference Scale of the Brief Pain Inventory. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Pain Catastrophising Scale (mediator) | Weeks 6 and 10 post-randomisation | Pain catastrophising assessed using the Pain Catastrophising Scale. The total score ranges from 0 to 52, with higher scores indicating a higher level of catastrophising. |
| Phantom limb movement scale (mediator) | Weeks 6 and 10 post-randomisation | The ability to move the phantom limb assessed on an 11-point Numerical Rating Scale (0: No movement at all, 10: Complete range of movement as if the limb were still present). |
| Phantom limb body perception disturbance scale (mediator) | Weeks 6 and 10 post-randomisation | The phantom limb body perception disturbances assessed using 4 questions measuring ownership, awareness, attention and emotional feelings on an 11-point Numerical Rating Scale (range, 0-40; lower scores indicate more severe body perception disturbances). Adapted from the Bath Complex Regional Pain Syndrome body perception disturbance scale. |
| Concept of Pain Inventory (mediator) | Weeks 6 and 10 post-randomisation | Beliefs and knowledge of pain science assessed using the Concept of Pain Inventory. This is a 13-item questionnaire with scores ranging from 0 to 52 points, with higher scores reflecting greater alignment with contemporary pain science. |
| Pain Self-Efficacy Questionnaire (mediator) | Weeks 6 and 10 post-randomisation | Pain self efficacy measured using the Pain Self-Efficacy Questionnaire. The total score of this questionnaire ranges from 0 to 60, with higher scores indicating higher self-efficacy and functioning despite ongoing pain. |
Countries
Australia
Contacts
Primary ContactJames H McAuley, PhD
Backup ContactRafael Z Pinto, PhD
Outcome results
None listed