TITAN Trial: Reducing Phantom Limb Pain in People with Amputations
NCT ID: NCT06167330
Last Updated: 2024-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
208 participants
INTERVENTIONAL
2023-12-18
2027-12-18
Brief Summary
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\- 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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Progressive rehabilitation program
Twelve-week treatment program delivered via eight, up to 1-hour telehealth sessions. The first five sessions will be scheduled every week, and the final three sessions will be scheduled fortnightly. Participants will also be prescribed approximately 15-30 minutes of home activities daily. The treatment program includes pain science education, sensory training, implicit and explicit motor imagery, and mirror therapy. Participants will complete activities at a self-directed pace following a standard progression protocol. Participant adherence will be measured via session attendance and self-report therapy diaries.
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.
Stimulation devices
Twelve-week treatment program delivered via eight, up to 1-hour telehealth sessions. The first five sessions will be scheduled every week, and the final three sessions will be scheduled fortnightly. Participants will also be prescribed approximately 15-30 minutes of home activities daily. 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. Participant adherence will be measured via session attendance and self-report therapy diaries.
Interventions
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Progressive rehabilitation program
Twelve-week treatment program delivered via eight, up to 1-hour telehealth sessions. The first five sessions will be scheduled every week, and the final three sessions will be scheduled fortnightly. Participants will also be prescribed approximately 15-30 minutes of home activities daily. The treatment program includes pain science education, sensory training, implicit and explicit motor imagery, and mirror therapy. Participants will complete activities at a self-directed pace following a standard progression protocol. Participant adherence will be measured via session attendance and self-report therapy diaries.
Stimulation devices
Twelve-week treatment program delivered via eight, up to 1-hour telehealth sessions. The first five sessions will be scheduled every week, and the final three sessions will be scheduled fortnightly. Participants will also be prescribed approximately 15-30 minutes of home activities daily. 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. Participant adherence will be measured via session attendance and self-report therapy diaries.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* Scheduled for major surgery during the study period.
* Pain in the intact limb.
* Vision impairment that would preclude successful participation.
* Auditory impairment that would preclude successful participation.
* Cognitive problems that would preclude effective participation in trial procedures (e.g., Alzheimer's, dementia).
* Previously diagnosed neurological disorders that affect the movement of the intact limb (e.g., stroke, Parkinson, Multiple Sclerosis).
* Completed Graded Motor Imagery in the order of left/right judgements, imagined movements, and mirror therapy.
* Have contraindications for the use of stimulation devices (e.g., pacemaker, spinal cord stimulator).
18 Years
ALL
No
Sponsors
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Neuroscience Research Australia
OTHER
Responsible Party
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James McAuley
Principal Investigator
Principal Investigators
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James H McAuley, PhD
Role: PRINCIPAL_INVESTIGATOR
Neuroscience Research Australia
Locations
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Neuroscience Research Australia
Randwick, New South Wales, Australia
Countries
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Central Contacts
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Facility Contacts
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James H McAuley, PhD
Role: primary
References
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Limakatso K, Cashin AG, Williams S, Devonshire J, Parker R, McAuley JH. The Efficacy of Graded Motor Imagery and Its Components on Phantom Limb Pain and Disability: A Systematic Review and Meta-Analysis. Can J Pain. 2023 May 17;7(1):2188899. doi: 10.1080/24740527.2023.2188899. eCollection 2023.
Related Links
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Trial website
Other Identifiers
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X23-0202 & 2023/ETH00540
Identifier Type: OTHER
Identifier Source: secondary_id
U1111-1296-2782
Identifier Type: -
Identifier Source: org_study_id