Peripheral Neuropathy Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You are able to give your own informed consent to participate
• You are 22 years of age or older
• You have had ongoing pain in your back, trunk, and/or limbs for at least 6 months
• Your average daily pain score is above 60 out of 100 on a pain rating scale, specifically related to back and/or limb pain
• You have already tried at least 3 medically supervised treatments (such as pain medications, physical therapy, joint injections, or acupuncture) and have used more than 2 different types of pain medication without enough relief
• Your pain medications have been stable and unchanged for at least 4 weeks before joining, and you agree not to add or increase pain medications during the study
• You have not had back surgery in the 6 months before screening
• Your daily opioid (strong painkiller) use over the past 30 days has been at or below a set limit (equivalent to 200mg of morphine per day)
• Your level of disability from pain falls within a specific mid-range on a standard disability questionnaire (score between 40 and 80 out of 100)
• You have been assessed and found to be a suitable candidate for spinal cord stimulation from a mental health perspective, within the past 180 days
• You are able to read and complete all study questionnaires independently in English
• If you are a woman who could become pregnant, you agree to use contraception throughout the study
• You have been assessed and approved as a good candidate for spinal cord stimulation by the lead study doctor and a board-certified pain specialist
• You are willing and able to follow all study requirements

Who may not be able to join:

• Your doctor has determined that you show signs of extreme catastrophising about your pain (for example, rating your pain as 100 out of 100 every single day for the week before screening)
• Your pain is caused by poor blood circulation in your limbs (peripheral vascular disease)
• You have received active cancer treatment in the past 6 months
• You are currently involved in a legal case related to a disability claim
• You are considered high risk for surgery, including a known allergy to titanium or silicone, a current body-wide infection, or an infection near where the device would be placed
• Your body mass index (BMI) is 45 or above at the time of screening
• You have a terminal illness and are not expected to survive more than 12 months
• Your immune system is significantly weakened
• You have significant memory or thinking difficulties that, in the study doctor's opinion, would prevent you from fully participating
• You are currently in, or plan to join, another clinical trial for a drug or device that could affect this study's results
• You have previously had a spinal cord stimulator trial or implant, or you already have an active implanted device such as a drug pump or implanted pulse generator
• You are pregnant, or you are a woman of childbearing age who plans to become pregnant during the study
• You plan to receive massage, physical manipulation directly over the device, or any treatment involving sudden jerking movements of the torso at any point during the study
• You have a medical condition that is likely to require a treatment called diathermy (a type of deep heat therapy that can interfere with implanted devices)
• You have any injury or medical or psychological condition that could be made significantly worse by the implant surgery or the presence of the device, or that could put your safety at risk
• You are unable to use the study devices, including a wrist-worn health sensor and a mobile phone app
• You have a documented history of substance misuse or dependency within the 6 months before the study baseline

Important: Always verify eligibility with the trial site directly before applying.