The Efficacy of Graded Motor Imagery and Its Components on Phantom Limb Pain and Disability: A Systematic Review and Meta-Analysis.
Katleho Limakatso, Aidan G Cashin, Sam Williams...
https://pubmed.ncbi.nlm.nih.gov/37214633Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID06167330
TITAN: a Randomised Controlled Trial Investigating the Effectiveness of Two Treatment Programs for Reducing Phantom Limb Pain Intensity and Its Interference with Function
Led by Neuroscience Research Australia · Updated on 2024-12-05
208
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of two different rehabilitation programs in people who have had amputations and experience phantom limb pain. This trial aims to determine whether a progressive rehabilitation program is more effective than a treatment using stimulation devices in reducing both the intensity of the pain and how much the pain interferes with daily function. The study is randomized and involves 208 participants. The trial compares a progressive rehabilitation program and a stimulation device program. The rehabilitation program includes pain science education, sensory training, motor imagery tasks, and mirror therapy, while the stimulation program involves transcutaneous electrical nerve stimulation and cranial electrical stimulation. Both programs are delivered through eight telehealth sessions over twelve weeks, with the first five sessions weekly and the last three every two weeks. Participants also complete daily home activities lasting 15 to 30 minutes at their own pace. Participants will be assessed at the start of the trial and then at 12, 24, and 52 weeks to measure pain intensity and interference, among other outcomes. Researchers will monitor adherence through session attendance and therapy diaries. Various questionnaires will also be used to evaluate pain severity, sleep quality, depression, self-efficacy, quality of life, and overall treatment effect. Safety is monitored through tracking adverse events. The total participation lasts about one year from randomization.
CONDITIONS
Brief Title
TITAN Trial: Reducing Phantom Limb Pain in People with Amputations
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Experiencing phantom limb pain for at least three months
- At least one episode of phantom limb pain in the previous week
- Pain intensity score of 4 or higher on an 11-point scale over the previous 7 days
- Resident in Australia for the intervention and follow-up period
- Access to the internet and a smart device such as a mobile phone
- Proficient in English
You will not qualify if you...
- Bilateral amputation
- Scheduled for major surgery during the study period
- Pain in the intact limb
- Vision impairment that would prevent participation
- Hearing impairment that would prevent participation
- Cognitive problems affecting participation (e.g., Alzheimer's, dementia)
- Previously diagnosed neurological disorders affecting movement of the intact limb (e.g., stroke, Parkinson's, Multiple Sclerosis)
- Completed Graded Motor Imagery including left/right judgements, imagined movements, and mirror therapy
- Contraindications for use of stimulation devices (e.g., pacemaker, spinal cord stimulator)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote) for eligibility assessment
Treatment
Duration - 12 weeks
Participants undergo a twelve-week treatment program consisting of eight telehealth sessions. The first five sessions occur weekly, followed by three sessions scheduled every two weeks. Participants are also prescribed daily home activities lasting approximately 15-30 minutes. Depending on their assigned group, participants will receive either a progressive rehabilitation program or stimulation device therapy.
8 telehealth sessions over 12 weeks
Follow-up
Duration - Up to 40 weeks post-treatment
Participants are monitored for pain intensity, pain interference, and other outcomes at multiple time points after treatment completion to assess long-term effects and safety.
Assessments at weeks 12, 24, and 52 post-randomisation
Trial Site Locations
Total: 1 location
1
Neuroscience Research Australia
Randwick, New South Wales, Australia, 2031
Actively Recruiting
Loading map...
Research Team
J
James H McAuley, PhD
R
Rafael Z Pinto, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here