Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06167330

TITAN Trial: Reducing Phantom Limb Pain in People with Amputations

Led by Neuroscience Research Australia · Updated on 2024-12-05

208

Participants Needed

1

Research Sites

208 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

TITAN Trial: Reducing Phantom Limb Pain in People with Amputations

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Experiencing phantom limb pain for at least three months
  • Had at least one episode of phantom limb pain in the previous week
  • Reported at least 4 points on pain intensity in the past 7 days using an 11-point scale
  • Resident in Australia during the intervention and follow-up period
  • Have access to the internet and a smart device like a mobile phone
  • Proficient in English
Not Eligible

You will not qualify if you...

  • Have bilateral amputation
  • Scheduled for major surgery during the study period
  • Have pain in the intact limb
  • Have vision impairment that prevents participation
  • Have hearing impairment that prevents participation
  • Have cognitive problems preventing participation (e.g., Alzheimer's, dementia)
  • Have neurological disorders affecting movement of the intact limb (e.g., stroke, Parkinson's, Multiple Sclerosis)
  • Have completed Graded Motor Imagery including left/right judgments, imagined movements, and mirror therapy
  • Have contraindications for stimulation devices (e.g., pacemaker, spinal cord stimulator)

AI-Screening

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Trial Site Locations

Total: 1 location

1

Neuroscience Research Australia

Randwick, New South Wales, Australia, 2031

Actively Recruiting

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Research Team

J

James H McAuley, PhD

CONTACT

R

Rafael Z Pinto, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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TITAN Trial: Reducing Phantom Limb Pain in People with Amputations | DecenTrialz