TITAN Trial: Reducing Phantom Limb Pain in People with Amputations

Neuroscience Research Australia

Status: Enrolling

Conditions: Amputation; Phantom Limb Pain

Treatments: Other: Progressive rehabilitation program; Other: Stimulation devices

Study type: Interventional

Funder types: Other

Identifiers

NCT06167330

U1111-1296-2782

X23-0202 & 2023/ETH00540 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 208 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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208 participants in 2 patient groups

Progressive rehabilitation program

Experimental group

Description:

The progressive rehabilitation program is a multicomponent intervention, including pain science education, sensory training, implicit and explicit motor imagery, and mirror therapy.

Treatment:

Other: Progressive rehabilitation program

Stimulation devices

Experimental group

Description:

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.

Treatment:

Other: Stimulation devices