Phantom Limb PainTITANNCT06167330
TITAN Trial: Reducing Phantom Limb Pain in People with Amputations
A study testing Progressive rehabilitation program and Stimulation devices in people with Phantom Limb Pain and Amputation, run by Neuroscience Research Australia at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Phantom Limb Pain, Amputation
- What is being tested?
- Progressive rehabilitation program and Stimulation devices
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 1 siteAustralia
- Study dates
- 18 Dec 2023to 18 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Rafael Z Pinto, PhD contact
Australia1 site, 1 recruiting
- Recruiting
Neuroscience Research Australia
Randwick, New South Wales, 2031
James H McAuley, PhD, +61293991266, j.mcauley@neura.edu.au
About this study
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
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.
- Conditions
- Phantom Limb Pain, Amputation
- Being tested
- Progressive rehabilitation program, Stimulation devices
- Medical subject headings
- Phantom Limb
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive rehabilitation programOther
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 devicesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Progressive rehabilitation program | Experimental | The progressive rehabilitation program is a multicomponent intervention, including pain science education, sensory training, implicit and explicit motor imagery, and mirror therapy. Receives: Other: Progressive rehabilitation program |
| Stimulation devices | Experimental | 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. Receives: Other: Stimulation devices |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Average pain intensity over the previous 7 days assessed using the 11-point Numerical Pain Rating Scale.
Measured: Week 12 post-randomisation
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.
Measured: Week 12 post-randomisation
Secondary outcomes (12)
Pain intensity
Average pain intensity over the previous 7 days assessed using the 11-point Numerical Pain Rating Scale.
Measured: Weeks 24 and 52 post-randomisation
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.
Measured: Weeks 24 and 52 post-randomisation
Pain severity
Average pain intensity over the previous 7 days assessed using the 0-10 Pain Severity Scale of the Brief Pain Inventory.
Measured: Weeks 12, 24 and 52 post-randomisation
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".
Measured: Weeks 12, 24 and 52 post-randomisation
PROMIS Self-Efficacy Manage Symptoms
Pain Self-efficacy assessed using PROMIS Self-Efficacy Manage Symptoms (Computer Adaptive Test) (28-item version; higher scores mean more self-efficacy).
Measured: Weeks 12, 24 and 52 post-randomisation
PROMIS Depression
Emotional distress and depression assessed using PROMIS Depression (Computer Adaptive Test) (28-item version; higher scores mean more depression).
Measured: Weeks 12, 24 and 52 post-randomisation
EuroQol 5-Dimension 5-Level (EQ-5D-5L)
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).
Measured: Weeks 12, 24 and 52 post-randomisation
Global Perceived Effect Scale
Perception of recovery assessed using the Global Perceived Effect scale (range from -5 to +5; higher scores mean greater improvement).
Measured: Weeks 12, 24 and 52 post-randomisation
Adverse events
Adverse events assessed via self-report.
Measured: From randomisation to week 12 post-randomisation
Adherence to treatment
Adherence to treatment assessed via session attendance and self-report (diary), including frequency per week and duration per day.
Measured: From randomisation to week 12 post-randomisation
Total health-care costs
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.
Measured: Weeks 12, 24 and 52 post-randomisation
Treatment rationale credibility
Treatment rationale credibility assessed using the Credibility and Expectancy Questionnaire. The total score ranges from 0 to 48, with lower scores indicating lower credibility.
Measured: Week 1 post-randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2023
- Study start18 Dec 2023
- Primary completion18 Dec 2026 (estimated)
- Study completion18 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Phantom Limb PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 208 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neuroscience Research Australia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James McAuley, Neuroscience Research Australia
- Investigators
- James H McAuley, PhD, Principal investigator, Neuroscience Research Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06167330
- Sponsor's protocol ID
- U1111-1296-2782
- Other IDs
- X23-0202 & 2023/ETH00540
- Acronym
- TITAN
- Status last verified
- Dec 2024
- First submitted
- 26 Nov 2023
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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).
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.
PubMed 37214633
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06167330
- Acronym / sponsor ID
- TITAN / U1111-1296-2782
- Conditions
- Phantom Limb Pain, Amputation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 208 participants (estimated)
- Lead sponsor
- Neuroscience Research AustraliaUniversity, hospital or other
- Study start
- 18 Dec 2023 (actual)
- Primary completion
- 18 Dec 2026 (estimated)
- Study completion
- 18 Dec 2027 (estimated)
- First posted
- 12 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Progressive rehabilitation program | Experimental | Other: Progressive rehabilitation programThe progressive rehabilitation program is a multicomponent intervention, including pain science education, sensory training, implicit and explicit motor imagery, and mirror therapy. |
| Stimulation devices | Experimental | Other: Stimulation devicesThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Progressive rehabilitation programTwelve-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 | Progressive rehabilitation program |
| Stimulation devicesTwelve-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. | Other | Stimulation devices |
Primary outcome
Pain intensity
Time frame: Week 12 post-randomisation
Average pain intensity over the previous 7 days assessed using the 11-point Numerical Pain Rating Scale.
Pain interference
Time frame: Week 12 post-randomisation
Average pain interference with function over the previous 7 days assessed using the 0-10 Pain Interference Scale of the Brief Pain Inventory.
12 secondary outcomes
Pain intensity
Time frame: Weeks 24 and 52 post-randomisation
Pain interference
Time frame: Weeks 24 and 52 post-randomisation
Pain severity
Time frame: Weeks 12, 24 and 52 post-randomisation
Sleep subscale of the Brief Pain Inventory's Pain Interference Scale
Time frame: Weeks 12, 24 and 52 post-randomisation
PROMIS Self-Efficacy Manage Symptoms
Time frame: Weeks 12, 24 and 52 post-randomisation
PROMIS Depression
Time frame: Weeks 12, 24 and 52 post-randomisation
EuroQol 5-Dimension 5-Level (EQ-5D-5L)
Time frame: Weeks 12, 24 and 52 post-randomisation
Global Perceived Effect Scale
Time frame: Weeks 12, 24 and 52 post-randomisation
Adverse events
Time frame: From randomisation to week 12 post-randomisation
Adherence to treatment
Time frame: From randomisation to week 12 post-randomisation
Total health-care costs
Time frame: Weeks 12, 24 and 52 post-randomisation
Treatment rationale credibility
Time frame: Week 1 post-randomisation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
- Background: PubMed 37214633Limakatso 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.
- Trial websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rafael Z Pinto, PhD contact
James H McAuley, PhD principal investigator
Neuroscience Research Australia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Progressive rehabilitation program and Stimulation devices in people with Phantom Limb Pain and Amputation, run by Neuroscience Research Australia at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact James H McAuley, PhD (+61293991266, j.mcauley@neura.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: Week 12 post-randomisation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06167330, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2024.