TITAN: a Randomised Controlled Trial Investigating the Effectiveness of Two Treatment Programs for Reducing Phantom Limb Pain Intensity and Its Interference with Function

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Australia
Neuroscience Research Australia
RECRUITING
Randwick
Contact Information
Primary
James H McAuley, PhD
j.mcauley@neura.edu.au
+61293991266
Backup
Rafael Z Pinto, PhD
r.zambelli@neura.edu.au
Time Frame
Start Date: 2023-12-18
Estimated Completion Date: 2027-12-18
Participants
Target number of participants: 208
Treatments
Experimental: Progressive rehabilitation program
The progressive rehabilitation program is a multicomponent intervention, including pain science education, sensory training, implicit and explicit motor imagery, and mirror therapy.
Experimental: Stimulation devices
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.
Related Therapeutic Areas
Sponsors
Leads: Neuroscience Research Australia

This content was sourced from clinicaltrials.gov