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Completed NCT07632508

F-18 Sodium Fluoride PET/CT Guided Versus Ultrasound- Guided Intra-articular Injections in Chronic Low Backache

Conditions: Chronic Low Back Pain

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 40
Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh

Location: Post Graduate Institute of Medical Education Research, Chandigarh Chandigarh Chandigarh

Summary

The goal of this open-label randomized controlled trial explored the efficacy of ultrasound guided versus F-18 Sodium Fluoride PET/CT guided local anesthetic and steroid injections in managing chronic low back pain caused by lumbar facet and sacroiliac joint arthritis.. The main questions it aims to answer are: 1. To Compare the reduction in pain intensity between PET/CT guided and Ultrasound Guided facet joint injections using the Visual Analog Scale (VAS) at predefined follow up intervals. 2. To compare functional improvement and disability outcomes between two study arms using Oswestry Disability Index (ODI) and Low Back Outcome Score (LBOS). 3. To compare association of PET/CT associated parameters with post intervention clinical response associated parameters. Patients fulfilling the inclusion criteria will be randomly allocated to one of two groups. Randomization will be conducted using a computer-generated random sequence, ensuring a 1:1 allocation ratio between the two treatment groups 1. Group A: Patients receiving F-18 sodium fluoride PET/CT-guided corticosteroid plus local anesthetic injection. 2. Group B: Patients receiving Ultrasound-guided corticosteroid plus local anesthetic injection

Eligibility Criteria

Inclusion Criteria: * Patients with a chronic nociceptive low backache attending the orthopaedic department who do not get adequate relief with conservative treatments for more than three months will be recruited in the study. * Patients who are ready to give informed consent Exclusion Criteria: * Pregnant and lactating females * Patients with active infection and febrile illness * Patients with acute spine trauma * Spinal pathologies requiring surgical interventions such as significant spinal stenosis , spondylolisthesis or disc herniation. * Patients with corticosteroid injection within six weeks before the study * Patients who refused to give written informed consent * MRI showing the neuropathic cause or nerve root compression * Patients with deranged coagulation profile * Systemic conditions affecting joints (eg ankylosing spondylitis , rheumatoid arthritis) * Uncontrolled diabetes

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07632508). StuddyBuddy aggregates publicly available trial information.