Clinical trial NCT06167330: TITAN Trial: Reducing Phantom Limb Pain in People with Amputations
Official title: TITAN: a Randomised Controlled Trial Investigating the Effectiveness of Two Treatment Programs for Reducing Phantom Limb Pain Intensity and Its Interference with Function
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Phantom Limb Pain
Amputation
Lead sponsor: Neuroscience Research Australia
Sponsor class: OTHER
First posted: 2023-12-12
Enrollment: 208
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Bilateral amputation.
* 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).

Primary outcomes:
measure: Pain intensity
timeFrame: Week 12 post-randomisation
measure: Pain interference
timeFrame: Week 12 post-randomisation
Secondary outcomes:
measure: Pain intensity
timeFrame: Weeks 24 and 52 post-randomisation
measure: Pain interference
timeFrame: Weeks 24 and 52 post-randomisation
measure: Pain severity
timeFrame: Weeks 12, 24 and 52 post-randomisation
measure: Sleep subscale of the Brief Pain Inventory's Pain Interference Scale
timeFrame: Weeks 12, 24 and 52 post-randomisation
measure: PROMIS Self-Efficacy Manage Symptoms
timeFrame: Weeks 12, 24 and 52 post-randomisation
measure: PROMIS Depression
timeFrame: Weeks 12, 24 and 52 post-randomisation
measure: EuroQol 5-Dimension 5-Level (EQ-5D-5L)
timeFrame: Weeks 12, 24 and 52 post-randomisation
measure: Global Perceived Effect Scale
timeFrame: Weeks 12, 24 and 52 post-randomisation
measure: Adverse events
timeFrame: From randomisation to week 12 post-randomisation
measure: Adherence to treatment
timeFrame: From randomisation to week 12 post-randomisation
measure: Total health-care costs
timeFrame: Weeks 12, 24 and 52 post-randomisation
measure: Treatment rationale credibility
timeFrame: Week 1 post-randomisation
Other outcomes:
measure: Pain Self-Efficacy Questionnaire (mediator)
timeFrame: Weeks 6 and 10 post-randomisation
measure: Concept of Pain Inventory (mediator)
timeFrame: Weeks 6 and 10 post-randomisation
measure: Pain Catastrophising Scale (mediator)
timeFrame: Weeks 6 and 10 post-randomisation
measure: Phantom limb movement scale (mediator)
timeFrame: Weeks 6 and 10 post-randomisation
measure: Phantom limb body perception disturbance scale (mediator)
timeFrame: Weeks 6 and 10 post-randomisation
Locations:
city: Randwick
country: Australia
facility: Neuroscience Research Australia
state: New South Wales
Study officials:
affiliation: Neuroscience Research Australia
name: James H McAuley, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.