TITAN Trial Comparing Two Telehealth Treatments to Reduce Phantom Limb Pain in Adults with Amputations

What this Trial Is About

Researchers are evaluating the effectiveness of two different rehabilitation programs in people who have had amputations and experience phantom limb pain. This trial aims to determine whether a progressive rehabilitation program is more effective than a treatment using stimulation devices in reducing both the intensity of the pain and how much the pain interferes with daily function. The study is randomized and involves 208 participants. The trial compares a progressive rehabilitation program and a stimulation device program. The rehabilitation program includes pain science education, sensory training, motor imagery tasks, and mirror therapy, while the stimulation program involves transcutaneous electrical nerve stimulation and cranial electrical stimulation. Both programs are delivered through eight telehealth sessions over twelve weeks, with the first five sessions weekly and the last three every two weeks. Participants also complete daily home activities lasting 15 to 30 minutes at their own pace. Participants will be assessed at the start of the trial and then at 12, 24, and 52 weeks to measure pain intensity and interference, among other outcomes. Researchers will monitor adherence through session attendance and therapy diaries. Various questionnaires will also be used to evaluate pain severity, sleep quality, depression, self-efficacy, quality of life, and overall treatment effect. Safety is monitored through tracking adverse events. The total participation lasts about one year from randomization.

TITAN Trial: Reducing Phantom Limb Pain in People with Amputations