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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:
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| F-18 Sodium Fluoride Guided intra-articular Injection | Active Comparator | Patients in this group will PET/CT guided intra articular block of the facet joint or sacroiliac joint using local anesthetic and corticosteroid |
|
| Ultrasound Guided Pain Palliation | Active Comparator | Patients in this group will undergo ultrasound-guided (USG) intra articular block of the facet joint or sacroiliac joint using local anesthetic and corticosteroid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intra-articular injection | Procedure | • A combination of steroids (80 mg methylprednisolone acetate) and 0.5% bupivacaine will be injected into the intra-articular and periarticular regions of the targeted LFJ(lumbar facet Joint) or SIJ(sacroiliac Joint) under F-18 sodium fluoride PET/CT guidance, with doses equally divided for multiple joints, if required |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Visual Analog Scale (VAS) Score | Change in pain intensity from baseline to follow-up as measured using the Visual Analog Scale (VAS). The VAS is a 10-point scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Lower scores indicate less pain. | From date of intervention to follow up at 20 weeks. |
| Change in Oswestry Disability Index (ODI) | Change in disability from baseline to follow-up as measured using the Oswestry Disability Index (ODI). The ODI is scored from 0% to 100%, with higher scores indicating greater disability and poorer functional status. Lower scores indicate improvement in disability. | From date of intervention to the follow up at 20 weeks |
| Change in Low Back Outcome Score (LBOS) | Change in functional outcome from baseline to follow-up as measured using the Low Back Outcome Score (LBOS). The LBOS ranges from 0 to 75 points, with higher scores indicating better functional outcome and lower levels of disability. Higher scores indicate improvement in functional status. | From date of intervention to follow up at 20 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between baseline SUVmax and improvement in Visual Analog Scale (VAS) score | Correlation between baseline maximum standardized uptake value (SUVmax) measured on PET/CT and change in pain severity assessed using the Visual Analog Scale (VAS; 0-10 points). Improvement will be calculated as the difference between baseline and follow-up VAS scores. Correlation analysis will be performed using Pearson's or Spearman's correlation coefficient, as appropriate. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Post Graduate Institute of Medical Education Research, Chandigarh | Chandigarh | Chandigarh | 160012 | India |
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|
| intra-articular injection | Procedure | A combination of steroids (80 mg methylprednisolone acetate) and 0.5% bupivacaine will be injected into the intra-articular and periarticular regions of the targeted LFJ(lumbar facet Joint) or SIJ(sacroiliac Joint) under ultrasound(USG) guidance, with doses equally divided for multiple joints, if required |
|
| From baseline F-18 Sodium fluoride PET/CT to follow up PET/CT and clinical assessment at 20 weeks |
| Correlation between baseline SUVmax and improvement in Oswestry Disability Index (ODI) score | Correlation between baseline maximum standardized uptake value (SUVmax) measured on PET/CT and change in disability assessed using the Oswestry Disability Index (ODI; 0-100%). Improvement will be calculated as the difference between baseline and follow-up ODI scores. Correlation analysis will be performed using Pearson's or Spearman's correlation coefficient, as appropriate. | From baseline F-18 sodium fluoride PET/CT to follow up PET/CT and clinical assessment at 20 weeks |
| Correlation between baseline SUVmax and improvement in Low Back Outcome Score (LBOS) | Correlation between baseline maximum standardized uptake value (SUVmax) measured on PET/CT and change in functional outcome assessed using the Low Back Outcome Score (LBOS; 0-75 points). Improvement will be calculated as the difference between baseline and follow-up LBOS scores. Correlation analysis will be performed using Pearson's or Spearman's correlation coefficient, as appropriate. | From baseline F-18 sodium fluoride PET/CT to follow up PET/CT and clinical assessment at 20 weeks |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D007270 | Injections, Intra-Articular |
| ID | Term |
|---|---|
| D007267 | Injections |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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