An interventional study of Progressive rehabilitation program and Stimulation devices in Phantom Limb Pain and Amputation, sponsored by Neuroscience Research Australia. Recruiting at 1 site in Australia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-05.
Sponsored by Neuroscience Research Australia · Not applicable, Interventional, and Treatment
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:
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.
163 studies on the registry are indexed under Phantom Limb; 35 are open to participants now.
This study's planned enrollment of 208 is above the median of 30 across 125 interventional studies indexed under Phantom Limb.
Browse Phantom Limb studies →Neuroscience Research Australia is the lead sponsor of 10 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The progressive rehabilitation program is a multicomponent intervention, including pain science education, sensory training, implicit and explicit motor imagery, and mirror therapy.
Other: Progressive rehabilitation program
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: 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 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.
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.
Pain intensity
Average pain intensity over the previous 7 days assessed using the 11-point Numerical Pain Rating Scale.
Time frame: 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.
Time frame: Week 12 post-randomisation
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-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.
Time frame: 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.
Time frame: 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".
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: Weeks 12, 24 and 52 post-randomisation
Adverse events
Adverse events assessed via self-report.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Week 1 post-randomisation
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-randomisation
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-randomisation
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-randomisation
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-randomisation
Phantom limb body perception disturbance scale (mediator)
The phantom limb body perception disturbances assessed using 4 questions measuring ownership, awareness, attention and emotional feelings on an 11-point Numerical Rating Scale (range, 0-40; lower scores indicate more severe body perception disturbances). Adapted from the Bath Complex Regional Pain Syndrome body perception disturbance scale.
Time frame: Weeks 6 and 10 post-randomisation
Plan to share: 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).
Supporting information: Study protocol, Statistical analysis plan
Time frame: Data will be made available after the publication of study reports. There is no end date for the availability of study data.
Started Dec 2023 (actual). Primary completion is estimated for Dec 2026, 36 months after the start.
Of 61 non-industry interventional studies with no phase under Phantom Limb, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 47. This study's planned 36 months is above that.
Counting every sponsor, half of 64 studies reached it within 34 months; a quarter within 13 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
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