TITAN Trial: Reducing Phantom Limb Pain in People with Amputations

Not Applicable

Recruiting

• Conditions: Amputation; Phantom Limb Pain
• Interventions: Other: Stimulation devices; Other: Progressive rehabilitation program

• Registration Number: NCT06167330
• Lead Sponsor: Neuroscience Research Australia

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-26
• Study First Submitted QC: 2023-12-07
• Study First Posted: 2023-12-12
• Study Start: 2023-12-18
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-05
• Primary Completion: 2026-12-18
• Study Completion: 2027-12-18

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 208

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stimulation devices	Stimulation devices	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.
Progressive rehabilitation program	Progressive rehabilitation program	The progressive rehabilitation program is a multicomponent intervention, including pain science education, sensory training, implicit and explicit motor imagery, and mirror therapy.

Primary Outcome Measures

Name	Time	Method
Pain interference	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.
Pain intensity	Week 12 post-randomisation	Average pain intensity over the previous 7 days assessed using the 11-point Numerical Pain Rating Scale.

Secondary Outcome Measures

Name	Time	Method
Adverse events	From randomisation to week 12 post-randomisation	Adverse events assessed via self-report.
Pain interference	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.
EuroQol 5-Dimension 5-Level (EQ-5D-5L)	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).
Pain intensity	Weeks 24 and 52 post-randomisation	Average pain intensity over the previous 7 days assessed using the 11-point Numerical Pain Rating Scale.
Pain severity	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.
Sleep subscale of the Brief Pain Inventory's Pain Interference Scale	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".
PROMIS Self-Efficacy Manage Symptoms	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).
PROMIS Depression	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).
Adherence to treatment	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.
Global Perceived Effect Scale	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).
Total health-care costs	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.
Treatment rationale credibility	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.

Trial Locations

Locations (1)

Neuroscience Research Australia; 🇦🇺 Randwick, New South Wales, Australia