TITAN Trial: Reducing Phantom Limb Pain in People with Amputations

Last updated: December 3, 2024
Sponsor: Neuroscience Research Australia
Overall Status: Active - Recruiting

Phase

N/A

Condition

Chronic Pain

Treatment

Progressive rehabilitation program

Stimulation devices

Clinical Study ID

NCT06167330
U1111-1296-2782
X23-0202 & 2023/ETH00540
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 usingthe 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

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 intactlimb (e.g., stroke, Parkinson, Multiple Sclerosis).

  • Completed Graded Motor Imagery in the order of left/right judgements, imaginedmovements, and mirror therapy.

  • Have contraindications for the use of stimulation devices (e.g., pacemaker, spinalcord stimulator).

Study Design

Total Participants: 208
Treatment Group(s): 2
Primary Treatment: Progressive rehabilitation program
Phase:
Study Start date:
December 18, 2023
Estimated Completion Date:
December 18, 2027

Connect with a study center

  • Neuroscience Research Australia

    Randwick, New South Wales 2031
    Australia

    Active - Recruiting

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