Reducing phantom limb pain in amputees
TITAN: a Randomised Controlled Trial Investigating the Effectiveness of Two Treatment Programs for Reducing Phantom Limb Pain Intensity and Its Interference with Function
This study is testing two different rehabilitation programs to see which one helps amputees with phantom limb pain feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 208 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Neuroscience Research Australia Academic / other |
| Locations | 1 site (Randwick, New South Wales) |
| Trial ID | NCT06167330 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of two rehabilitation programs for individuals with amputations experiencing phantom limb pain. Participants will be randomized into two groups: one receiving a progressive rehabilitation program that includes pain science education, sensory training, and mirror therapy, and the other receiving treatment with transcutaneous electrical nerve stimulation and cranial electrical stimulation. The study aims to determine which approach is more effective in reducing pain intensity and interference. A total of 208 participants will be involved in this research.
Who should consider this trial
Good fit: Ideal candidates are individuals who have undergone an amputation and have been experiencing phantom limb pain for at least three months.
Not a fit: Patients with bilateral amputations or those with cognitive impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce phantom limb pain for amputees, improving their quality of life.
How similar studies have performed: Other studies have shown varying degrees of success with rehabilitation and stimulation approaches for phantom limb pain, but this specific comparison is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Randwick, New South Wales
- Neuroscience Research Australia — Randwick, New South Wales, Australia (Recruiting)
Study contacts
- Principal investigator: James H McAuley, PhD — Neuroscience Research Australia
- Study coordinator: James H McAuley, PhD
- Email: j.mcauley@neura.edu.au
- Phone: +61293991266
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.