Chronic Low-back Pain Clinical Trial
Official title:
F-18 Sodium Fluoride PET/CT Guided Robotic Arm-assisted Pain Palliation in Chronic Nociceptive Low Backache
A study to investigate the role of F-18 sodium fluoride in localizing the pain generator in participants with chronic nociceptive musculoskeletal low back ache and to study the use of PET/CT guided robotic arm assisted injection for targeted injection of a combination of corticosteroid and local anesthetic for pain palliation.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | December 31, 2022 |
Est. primary completion date | November 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Participants with chronic nociceptive low back ache (for more than three months) do not have adequate pain relief with oral analgesics. - Participants who are ready to give written informed consent for the procedure Exclusion Criteria: - MRI showing the neuropathic cause of pain with spinal cord or nerve root compression. - Extensive bone or joint destruction and displacement such as spondylolisthesis or compression fractures of the vertebra. - Imaging, clinical and hematological findings suggestive of infective/ malignant pathology. - Patients with deranged coagulation profile - Pregnant and lactating women |
Country | Name | City | State |
---|---|---|---|
India | Department of Nuclear Medicine, Post Graduate Institute of Medical Education and Research | Chandigarh |
Lead Sponsor | Collaborator |
---|---|
Postgraduate Institute of Medical Education and Research |
India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Diagnostic efficacy of the procedure | Diagnostic efficacy of F-18 sodium fluoride PET/CT for localizing the site of pain in patients with chronic nociceptive low back ache and assessing the reduction in pain following the procedure.The procedure will be believed as technically successful if there is a 50% decrease in the severity of pain following the procedure as assessed by the visual analogue score. | Immediate - post procedure | |
Primary | Treatment efficacy of the procedure | Treatment efficacy of injection of a combination of corticosteroid and local anesthetic intraarticularly following localization by F-18 sodium fluoride PET/CT in patients with chronic nociceptive low back ache. The visual analog score will be used to document the sustained reduction in pain for one month following the procedure. | One month | |
Secondary | Safety of F-18 sodium fluoride PET/CT guided robotic arm assisted injection of local anesthetic and steroids. | To assess the immediate and delayed adverse effects following the procedure upto a period of one month. | Immediately following the procedure till 30 minutes and upto one month following the procedure | |
Secondary | Imaging based response assessment following F-18 sodium fluoride PET/CT guided robotic arm assisted injection of local anesthetic and steroids. | To quantify the resolution or decrease in the intensity of the tracer uptake in the target joints to assess the objective response to injection of local anesthetic and steroids by using F-18 sodium fluoride PET/CT at one month following injection. The images will be compared with those acquired at baseline to assess the response. | One month |
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