TITAN Trial: Reducing Phantom Limb Pain in People with Amputations

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

Overview

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.

Interventions

• Other 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 standa
• 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 transcutaneous electrical nerve stimulation and cranial electrical stimulation. Participants will complete activities at a self-directed pace following a standard progression prot

Primary outcome measures

• Pain intensity [Time frame: Week 12 post-randomisation]
• Pain interference [Time frame: Week 12 post-randomisation]

Secondary outcome measures (12)

• 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]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Australia · 1 center

• Neuroscience Research Australia — Randwick

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. PMID 37214633

Identifiers

NCT: NCT06167330 · U1111-1296-2782 · X23-0202 & 2023/ETH00540

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗