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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT06167330
Registration number
NCT06167330
Ethics application status
Date submitted
26/11/2023
Date registered
12/12/2023
Date last updated
12/02/2024
Titles & IDs
Public title
TITAN Trial: Reducing Phantom Limb Pain in People With Amputations
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Scientific title
TITAN: a Randomised Controlled Trial Investigating the Effectiveness of Two Treatment Programs for Reducing Phantom Limb Pain Intensity and Its Interference With Function
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Secondary ID [1]
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X23-0202 & 2023/ETH00540
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Secondary ID [2]
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U1111-1296-2782
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Universal Trial Number (UTN)
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Trial acronym
TITAN
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Phantom Limb Pain
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Amputation
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Condition category
Condition code
Mental Health
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Other mental health disorders
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Neurological
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Other neurological disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Progressive rehabilitation program
Other interventions - Stimulation devices
Experimental: 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.
Experimental: 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.
Other interventions: 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.
Other interventions: 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.
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Pain intensity
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Assessment method [1]
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Average pain intensity over the previous 7 days assessed using the 11-point Numerical Pain Rating Scale.
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Timepoint [1]
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Week 12 post-randomisation
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Primary outcome [2]
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Pain interference
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Assessment method [2]
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Average pain interference with function over the previous 7 days assessed using the 0-10 Pain Interference Scale of the Brief Pain Inventory.
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Timepoint [2]
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Week 12 post-randomisation
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Secondary outcome [1]
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Pain intensity
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Assessment method [1]
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Average pain intensity over the previous 7 days assessed using the 11-point Numerical Pain Rating Scale.
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Timepoint [1]
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Weeks 24 and 52 post-randomisation
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Secondary outcome [2]
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Pain interference
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Assessment method [2]
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Average pain interference with function over the previous 7 days assessed using the 0-10 Pain Interference Scale of the Brief Pain Inventory.
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Timepoint [2]
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Weeks 24 and 52 post-randomisation
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Secondary outcome [3]
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Pain severity
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Assessment method [3]
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Average pain intensity over the previous 7 days assessed using the 0-10 Pain Severity Scale of the Brief Pain Inventory.
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Timepoint [3]
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Weeks 12, 24 and 52 post-randomisation
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Secondary outcome [4]
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Sleep subscale of the Brief Pain Inventory's Pain Interference Scale
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Assessment method [4]
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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".
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Timepoint [4]
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Weeks 12, 24 and 52 post-randomisation
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Secondary outcome [5]
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PROMIS Self-Efficacy Manage Symptoms
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Assessment method [5]
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Pain Self-efficacy assessed using PROMIS Self-Efficacy Manage Symptoms (Computer Adaptive Test) (28-item version; higher scores mean more self-efficacy).
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Timepoint [5]
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Weeks 12, 24 and 52 post-randomisation
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Secondary outcome [6]
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PROMIS Depression
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Assessment method [6]
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Emotional distress and depression assessed using PROMIS Depression (Computer Adaptive Test) (28-item version; higher scores mean more depression).
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Timepoint [6]
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Weeks 12, 24 and 52 post-randomisation
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Secondary outcome [7]
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EuroQol 5-Dimension 5-Level (EQ-5D-5L)
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Assessment method [7]
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Health-Related Quality of Life assessed using the EQ-5D-5L dimensions scale range, 1-5; higher scores indicate better quality of life) and health thermometer (range, 0-100; higher scores indicate better quality of life).
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Timepoint [7]
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Weeks 12, 24 and 52 post-randomisation
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Secondary outcome [8]
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Global Perceived Effect Scale
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Assessment method [8]
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Perception of recovery assessed using the Global Perceived Effect scale (range from -5 to +5; higher scores mean greater improvement).
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Timepoint [8]
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Weeks 12, 24 and 52 post-randomisation
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Secondary outcome [9]
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Adverse events
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Assessment method [9]
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Adverse events assessed via self-report.
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Timepoint [9]
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From randomisation to week 12 post-randomisation
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Secondary outcome [10]
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Adherence to treatment
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Assessment method [10]
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Adherence to treatment assessed via session attendance and self-report (diary), including frequency per week and duration per day.
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Timepoint [10]
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From randomisation to week 12 post-randomisation
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Secondary outcome [11]
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Total health-care costs
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Assessment method [11]
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Total health-care costs will be estimated as the trial intervention costs and outside trial health-care resource use attributable to phantom limb pain from the Medicare Benefits Scheme and Pharmaceutical Benefits Scheme. Quality-adjusted life-years (QALYs) from the EQ-5D-5L using the Australian utility weights will also be used in the trial-based cost-utility analysis.
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Timepoint [11]
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Weeks 12, 24 and 52 post-randomisation
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Secondary outcome [12]
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Treatment rationale credibility
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Assessment method [12]
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Treatment rationale credibility assessed using the Credibility and Expectancy Questionnaire. The total score ranges from 0 to 48, with lower scores indicating lower credibility.
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Timepoint [12]
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Week 1 post-randomisation
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
18/12/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
18/12/2027
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Actual
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Sample size
Target
208
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Neuroscience Research Australia - Randwick
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Recruitment postcode(s) [1]
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2031 - Randwick
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Funding & Sponsors
Primary sponsor type
Other
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Name
Neuroscience Research Australia
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT06167330
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Trial related presentations / publications
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.
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Public notes
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Contacts
Principal investigator
Name
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James H McAuley, PhD
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Address
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Neuroscience Research Australia
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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James H McAuley, PhD
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Address
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Country
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Phone
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+61293991266
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT06167330
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