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

Post Graduate Institute of Medical Education and Research, Chandigarh40 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Chronic Low Back Pain

Interventions

intra-articular injectionPROCEDURE

• 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

intra-articular injectionPROCEDURE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: From date of intervention to follow up at 20 weeks

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.