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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06167330




Registration number
NCT06167330
Ethics application status
Date submitted
26/11/2023
Date registered
12/12/2023

Titles & IDs
Public title
TITAN Trial: Reducing Phantom Limb Pain in People with Amputations
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
Secondary ID [1] 0 0
X23-0202 & 2023/ETH00540
Secondary ID [2] 0 0
U1111-1296-2782
Universal Trial Number (UTN)
Trial acronym
TITAN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Phantom Limb Pain 0 0
Amputation 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Other mental health disorders
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Pain intensity
Timepoint [1] 0 0
Week 12 post-randomisation
Primary outcome [2] 0 0
Pain interference
Timepoint [2] 0 0
Week 12 post-randomisation
Secondary outcome [1] 0 0
Pain intensity
Timepoint [1] 0 0
Weeks 24 and 52 post-randomisation
Secondary outcome [2] 0 0
Pain interference
Timepoint [2] 0 0
Weeks 24 and 52 post-randomisation
Secondary outcome [3] 0 0
Pain severity
Timepoint [3] 0 0
Weeks 12, 24 and 52 post-randomisation
Secondary outcome [4] 0 0
Sleep subscale of the Brief Pain Inventory's Pain Interference Scale
Timepoint [4] 0 0
Weeks 12, 24 and 52 post-randomisation
Secondary outcome [5] 0 0
PROMIS Self-Efficacy Manage Symptoms
Timepoint [5] 0 0
Weeks 12, 24 and 52 post-randomisation
Secondary outcome [6] 0 0
PROMIS Depression
Timepoint [6] 0 0
Weeks 12, 24 and 52 post-randomisation
Secondary outcome [7] 0 0
EuroQol 5-Dimension 5-Level (EQ-5D-5L)
Timepoint [7] 0 0
Weeks 12, 24 and 52 post-randomisation
Secondary outcome [8] 0 0
Global Perceived Effect Scale
Timepoint [8] 0 0
Weeks 12, 24 and 52 post-randomisation
Secondary outcome [9] 0 0
Adverse events
Timepoint [9] 0 0
From randomisation to week 12 post-randomisation
Secondary outcome [10] 0 0
Adherence to treatment
Timepoint [10] 0 0
From randomisation to week 12 post-randomisation
Secondary outcome [11] 0 0
Total health-care costs
Timepoint [11] 0 0
Weeks 12, 24 and 52 post-randomisation
Secondary outcome [12] 0 0
Treatment rationale credibility
Timepoint [12] 0 0
Week 1 post-randomisation

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.
* Have contraindications for the use of stimulation devices (e.g., pacemaker, spinal cord stimulator).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/12/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
18/12/2027
Actual
Sample size
Target
208
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Neuroscience Research Australia - Randwick
Recruitment postcode(s) [1] 0 0
2031 - Randwick

Funding & Sponsors
Primary sponsor type
Other
Name
Neuroscience Research Australia
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
James H McAuley, PhD
Address 0 0
Neuroscience Research Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
James H McAuley, PhD
Address 0 0
Country 0 0
Phone 0 0
+61293991266
Fax 0 0
Email 0 0
j.mcauley@neura.edu.au
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified individual participant data will be made to interested researchers only upon reasonable request and once the proposed research project has received separate ethics approval from a Human Research Ethics Committee.

Request to the data custodian, the Principal Investigator (j.mcauley@neura.edu.au).

Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
Data will be made available after the publication of study reports. There is no end date for the availability of study data.
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06167330