COPD 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:

• People who are 18 years of age or older at the time of screening
• People whose main problem is lower back pain that appears to be coming from the small joints along the spine (called facet joints), affecting both sides of the back, based on physical examination findings
• People whose lower back pain has been ongoing for 3 months or longer
• People whose lower back pain is moderate to severe, rated between 5 and 9 out of 10 on a pain scale at screening
• People whose lower back pain significantly limits their daily activities, scoring 30% or higher on a standard back disability questionnaire at screening
• People who have had two separate nerve-numbing injections (called diagnostic medial branch blocks, using local anaesthetic only, no steroids) that each reduced their main back pain by at least 80% for the expected duration of the anaesthetic
• People who have already tried at least three months of non-surgical treatments without enough relief (for example, physiotherapy, chiropractic care, anti-inflammatory medications, exercise programmes, or spinal injections)
• People who are able to give informed consent, attend all scheduled study visits, and complete all required assessments

Who may not be able to join:

• People who have an active workers' compensation claim, personal injury case, disability insurance claim, or any other legal matter related to their spine
• People whose MRI scans show serious spinal conditions, including suspected cauda equina syndrome (loss of bowel or bladder control), spinal infection, a tumour, a fracture caused by injury, inflammatory spinal disease, nerve root irritation or damage (radiculopathy), or pain in the legs caused by narrowing of the spinal canal (neurogenic claudication)
• People who have previously had spinal fusion surgery at the area of the back intended for treatment
• People with other health conditions that, in the treating doctor's judgement, could affect their ability to take part in the study, including nerve pain disorders
• People who are currently pregnant, breastfeeding, or planning to become pregnant during the study period
• People with certain medical conditions that may be a reason not to use the study device, including: a blood condition called cryoglobulinemia; a condition where cold triggers breakdown of red blood cells (paroxysmal cold hemoglobinuria); a cold-triggered skin reaction (cold urticaria); Raynaud's disease; open or infected wounds near the treatment area; or a blood clotting disorder
• People with a severe chronic pain condition that, in the investigator's opinion, could affect study results
• People who have a spinal neurostimulator, an implanted drug pump delivering medication to the spine, or a cardiac implantable device (such as a pacemaker)
• People with poorly controlled mental health conditions that, in the investigator's opinion, could meaningfully affect treatment results — including a mood disorder (such as depression or bipolar disorder) with a PHQ-9 score of 12 or higher at screening; a psychotic disorder such as schizophrenia; or high levels of catastrophising, measured by a Pain Catastrophizing Scale score above 30 at screening
• People who received any other spine treatment at the intended treatment area in the 30 days before the diagnostic nerve block injections (for example, spinal injections, minimally invasive procedures, or surgery)
• People who had radiofrequency ablation (a heat-based nerve treatment) in the lower back at the intended treatment area within the 6 months before enrolling in the study
• People whose pain relief after the diagnostic nerve block injections lasted longer than 24 hours
• People with a history of, or current, alcohol misuse or dependence, illicit drug use, or opioid misuse or dependence (including those taking 40 mg or more of opioid medication per day in the past 30 days)
• People who are not medically cleared for a procedure, including those with recent or suspected COVID-19 illness or symptoms, or other serious illness, as assessed by the investigator

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