TITAN Trial: Reducing Phantom Limb Pain in People with Amputations

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.

NCT Number	NCT06167330
Lead Sponsor	Neuroscience Research Australia
Conditions	Phantom Limb Pain, Amputation
Enrollment	208 participants
Start Date	2023-12-18
Primary Completion	2026-12-18 (estimated)
Study Completion	2027-12-18 (estimated)
Updated on ClinicalTrials.gov	2024-12-05