TITAN Trial: Reducing Phantom Limb Pain in People with Amputations
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNeuroscience Research Australia
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
Bilateral amputation.
Scheduled for major surgery during the study period.
Pain in the intact limb.
Vision impairment that would preclude successful participation.
Trial design
Treatments tested in this trial
- Progressive rehabilitation program
- Stimulation devices
Treatment groups
208 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov