Osteoarthritis 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:

• Adults between 18 and 75 years of age (male or female)
• People who have been diagnosed with osteoarthritis of the small joints in the lower spine (from the L1 to S1 region), as confirmed by a doctor involved in the trial
• People who have had ongoing low back pain for at least 6 months
• People who have already tried at least 3 months of standard treatments for back pain without enough relief — these may include rest, medications, massage, acupuncture, chiropractic care, activity changes, or other non-surgical pain treatments
• People who have completed a supervised physical therapy program specifically for low back pain, such as guided walking, therapeutic exercises, or back education
• People whose spine imaging shows changes at the affected level that are consistent with facet joint osteoarthritis
• People whose average pain level over 24 hours is at least 4 out of 10
• People who experienced more than 80% pain relief after a diagnostic injection into the affected joint
• People who are willing to give written consent to participate and are available to attend all scheduled visits throughout the study

Who may not be able to join:

• People who are pregnant, currently breastfeeding, or planning to become pregnant within 12 months of treatment
• Women of childbearing age who are not using or do not plan to use an accepted form of birth control for the duration of the study, or who have not been using one for at least one month before entering the study (accepted methods include hormonal contraception, barrier methods, intrauterine devices, surgical sterilisation, transdermal delivery, confirmed sterility, or abstinence)
• People with a Body Mass Index (BMI) over 40, which is classified as extreme obesity under NIH guidelines
• People who have had an injection into a spinal disc in the affected or nearby area within the past 3 months (some specific injection types may be permitted if given at least 2 weeks before the study treatment — confirm with trial site)
• People who have had an epidural steroid injection, a facet joint injection, a nerve block, or a radiofrequency nerve procedure within the past 8 weeks
• People who have taken corticosteroid medications (such as prednisone at 10 mg/day or more) for more than 7 consecutive days within the past 14 days
• People with an active cancer or tumour, or a history of cancer within the past 2 years (some skin and cervical cancers that have been fully removed with clear margins may be excepted — confirm with trial site)
• People currently enrolled in another clinical trial that has not yet reached its main outcome point
• People who have previously received donor stem cell therapy for any reason, or their own stem cell therapy or other biological treatment to repair the affected spinal disc or joint
• People whose average daily opioid pain medication use is above a set threshold (equivalent to more than 40 mg of morphine per day)
• People considered at higher risk for bleeding (such as those with a bleeding disorder or taking blood thinners, apart from low-dose aspirin) or infection (such as those taking immune-suppressing medications, or with a serious current or past infection), in the opinion of the trial doctor
• People with a current spinal infection or a history of infection at the affected spinal level, or an active infection anywhere in the body
• People with other severe or long-term pain conditions that may make it difficult to assess the facet joint symptoms specifically, in the opinion of the trial doctor
• People with cauda equina syndrome (a condition involving nerve compression at the base of the spine)
• People currently receiving workers' compensation where a legal case has not yet been resolved
• People considered part of a vulnerable population who may not be able to give fully informed consent — this includes individuals with cognitive or intellectual disability, children, people in emergency situations, or those in settings with hierarchical authority (confirm with trial site)
• People with a documented history of alcohol or drug misuse within the past year
• People whom the trial doctor considers unable to follow the study requirements for any reason, including completing patient questionnaires
• People whose body shape or size makes it impossible to get clear enough imaging during the procedure, or for whom the injection physically cannot be performed
• People who had problems with movement, sensation, or reflexes on a neurological examination at the time of screening
• People receiving immune-suppressing treatment, or who have a known serious immune or autoimmune condition requiring ongoing immune-modifying therapy (such as HIV, lupus, or rheumatoid arthritis)
• People with significant nerve pain (such as chronic radiculopathy) or significant sacroiliac joint pain, as determined by physical examination and, if needed, a confirming injection
• People with significant narrowing of the spinal nerve openings at the affected level causing nerve compression, in the opinion of the trial doctor
• People with significant narrowing of the central spinal canal, side recesses, or nerve openings, in the opinion of the trial doctor
• People with severe spinal instability that the trial doctor believes would require surgical stabilisation
• People with an acute (recent) spinal fracture, or vertebrae at the affected level that have been significantly weakened by past or current injury or fractures
• People with a history of ongoing tobacco or nicotine use
• People who do not have enough body fat tissue to allow collection of at least 100 mL of fat during the procedure
• People with a documented allergy to contrast dye used in imaging, sodium citrate, or any local anaesthetic of the "caine" type (such as lidocaine or bupivacaine)
• People with radiating leg pain (pain travelling down the leg from the spine), as determined by the trial doctor

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