TITAN Trial: Reducing Phantom Limb Pain in People with Amputations
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNeuroscience Research Australia
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Bilateral amputation.
Scheduled for major surgery during the study period.
Pain in the intact limb.
Vision impairment that would preclude successful participation.
Trial design
Design model
Parallel
Treatments tested in this trial
Progressive rehabilitation program
Other interventionTwelve-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
Other interventionTwelve-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.
Treatment groups
208 Participants
are divided into 2 treatment groupsGroup A: Progressive rehabilitation programExperimental treatment 1 intervention
Group B: Stimulation devicesExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Pain intensity
Average pain intensity over the previous 7 days assessed using the 11-point Numerical Pain Rating Scale.
Time frame
Week 12 post-randomisation2
Pain interference
Average pain interference with function over the previous 7 days assessed using the 0-10 Pain Interference Scale of the Brief Pain Inventory.
Time frame
Week 12 post-randomisationSecondary outcomes
1
Pain intensity
Average pain intensity over the previous 7 days assessed using the 11-point Numerical Pain Rating Scale.
Time frame
Weeks 24 and 52 post-randomisation2
Pain interference
Average pain interference with function over the previous 7 days assessed using the 0-10 Pain Interference Scale of the Brief Pain Inventory.
Time frame
Weeks 24 and 52 post-randomisation3
Pain severity
Average pain intensity over the previous 7 days assessed using the 0-10 Pain Severity Scale of the Brief Pain Inventory.
Time frame
Weeks 12, 24 and 52 post-randomisation4
Sleep subscale of the Brief Pain Inventory's Pain Interference Scale
Sleep Quality assessed using the Sleep subscale of the Brief Pain Inventory's Pain Interference Scale. The participants will rate the interference of pain with sleep on a 0-10 scale where "0" represents "does not interfere" and "10" represents "completely interferes".
Time frame
Weeks 12, 24 and 52 post-randomisationOther outcomes
1
Pain Self-Efficacy Questionnaire (mediator)
Pain self efficacy measured using the Pain Self-Efficacy Questionnaire. The total score of this questionnaire ranges from 0 to 60, with higher scores indicating higher self-efficacy and functioning despite ongoing pain.
Time frame
Weeks 6 and 10 post-randomisation2
Concept of Pain Inventory (mediator)
Beliefs and knowledge of pain science assessed using the Concept of Pain Inventory. This is a 13-item questionnaire with scores ranging from 0 to 52 points, with higher scores reflecting greater alignment with contemporary pain science.
Time frame
Weeks 6 and 10 post-randomisation3
Pain Catastrophising Scale (mediator)
Pain catastrophising assessed using the Pain Catastrophising Scale. The total score ranges from 0 to 52, with higher scores indicating a higher level of catastrophising.
Time frame
Weeks 6 and 10 post-randomisation4
Phantom limb movement scale (mediator)
The ability to move the phantom limb assessed on an 11-point Numerical Rating Scale (0: No movement at all, 10: Complete range of movement as if the limb were still present).
Time frame
Weeks 6 and 10 post-randomisationSponsors and contacts
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Source ClinicalTrials.gov