TITAN Trial: Reducing Phantom Limb Pain in People with Amputations

NCT06167330 | Recruiting

• 2 other identifiers: U1111-1296-2782X23-0202 & 2023/ETH00540
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 1

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.

Conditions

Phantom Limb Pain; Amputation

Outcome Measures

Primary Outcomes (2)

• Pain intensity

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

  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.

  Week 12 post-randomisation

Secondary Outcomes (12)

• Pain intensity

  Weeks 24 and 52 post-randomisation

• Pain interference

  Weeks 24 and 52 post-randomisation

• Pain severity

  Weeks 12, 24 and 52 post-randomisation

• Sleep subscale of the Brief Pain Inventory's Pain Interference Scale

  Weeks 12, 24 and 52 post-randomisation

• PROMIS Self-Efficacy Manage Symptoms

  Weeks 12, 24 and 52 post-randomisation

Other Outcomes (5)

• Pain Self-Efficacy Questionnaire (mediator)

  Weeks 6 and 10 post-randomisation

• Concept of Pain Inventory (mediator)

  Weeks 6 and 10 post-randomisation

• Pain Catastrophising Scale (mediator)

  Weeks 6 and 10 post-randomisation

Study Arms (2)

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.

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.

Other: Stimulation devices

Interventions

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.

Progressive rehabilitation program

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.

Stimulation devices

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Neuroscience Research Australia: lead

Study Sites (1)

Neuroscience Research Australia

Randwick, New South Wales, 2031, Australia

RECRUITING

Related Publications (1)

• 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.

  PMID: 37214633 BACKGROUND

Related Links

• Trial website

MeSH Terms

Conditions

Phantom Limb

Condition Hierarchy (Ancestors)

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

Study Officials

• James H McAuley, PhD

  Neuroscience Research Australia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

James H McAuley, PhD

CONTACT

+61293991266; j.mcauley@neura.edu.au

Rafael Z Pinto, PhD

CONTACT

r.zambelli@neura.edu.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 26, 2023
• First Posted: December 12, 2023
• Study Start: December 18, 2023
• Primary Completion (Estimated): December 18, 2026
• Study Completion (Estimated): December 18, 2027
• Last Updated: December 5, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be made available after the publication of study reports. There is no end date for the availability of study data.

Locations

AU (1)