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NCT Number: NCT06167330

TITAN Trial: Reducing Phantom Limb Pain in People with Amputations

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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Key information

Conditions

Phantom Limb Pain Amputation Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Phantom Limb Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Neuroscience Research Australia

Randwick, New South Wales, 2031, Australia

Location status: Recruiting

Location contact

James H McAuley, PhD

CONTACT

[email protected]

+61293991266

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

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).

Treatment and study plan

Progressive rehabilitation program

Other

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 devices

Other

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Pain intensity

    Time frame: Weeks 24 and 52 post-randomisation

    Average pain intensity over the previous 7 days assessed using the 11-point Numerical Pain Rating Scale.

  2. Pain interference

    Time frame: Weeks 24 and 52 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.

  3. Pain severity

    Time frame: Weeks 12, 24 and 52 post-randomisation

    Average pain intensity over the previous 7 days assessed using the 0-10 Pain Severity Scale of the Brief Pain Inventory.

  4. Sleep subscale of the Brief Pain Inventory's Pain Interference Scale

    Time frame: Weeks 12, 24 and 52 post-randomisation

    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".

  5. PROMIS Self-Efficacy Manage Symptoms

    Time frame: Weeks 12, 24 and 52 post-randomisation

    Pain Self-efficacy assessed using PROMIS Self-Efficacy Manage Symptoms (Computer Adaptive Test) (28-item version; higher scores mean more self-efficacy).

  6. PROMIS Depression

    Time frame: Weeks 12, 24 and 52 post-randomisation

    Emotional distress and depression assessed using PROMIS Depression (Computer Adaptive Test) (28-item version; higher scores mean more depression).

  7. EuroQol 5-Dimension 5-Level (EQ-5D-5L)

    Time frame: Weeks 12, 24 and 52 post-randomisation

    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).

  8. Global Perceived Effect Scale

    Time frame: Weeks 12, 24 and 52 post-randomisation

    Perception of recovery assessed using the Global Perceived Effect scale (range from -5 to +5; higher scores mean greater improvement).

  9. Adverse events

    Time frame: From randomisation to week 12 post-randomisation

    Adverse events assessed via self-report.

  10. Adherence to treatment

    Time frame: From randomisation to week 12 post-randomisation

    Adherence to treatment assessed via session attendance and self-report (diary), including frequency per week and duration per day.

  11. Total health-care costs

    Time frame: Weeks 12, 24 and 52 post-randomisation

    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.

  12. Treatment rationale credibility

    Time frame: Week 1 post-randomisation

    Treatment rationale credibility assessed using the Credibility and Expectancy Questionnaire. The total score ranges from 0 to 48, with lower scores indicating lower credibility.

Other outcomes

  1. Pain Self-Efficacy Questionnaire (mediator)

    Time frame: Weeks 6 and 10 post-randomisation

    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.

  2. Concept of Pain Inventory (mediator)

    Time frame: Weeks 6 and 10 post-randomisation

    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.

  3. Pain Catastrophising Scale (mediator)

    Time frame: Weeks 6 and 10 post-randomisation

    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.

  4. Phantom limb movement scale (mediator)

    Time frame: Weeks 6 and 10 post-randomisation

    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).

  5. Phantom limb body perception disturbance scale (mediator)

    Time frame: Weeks 6 and 10 post-randomisation

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

James H McAuley, PhD

CONTACT

[email protected]

+61293991266

Rafael Z Pinto, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Neuroscience Research Australia

Other

Registry information

Official study title

TITAN: a Randomised Controlled Trial Investigating the Effectiveness of Two Treatment Programs for Reducing Phantom Limb Pain Intensity and Its Interference with Function

Acronym: TITAN

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Dec 12, 2023
Registry last updated
Dec 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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