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

NCT07632508 | Completed

• 1 other identifier: INT/IEC/2025/SPL-1127
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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. 2.To compare functional improvement and disability outcomes between two study arms using Oswestry Disability Index (ODI) and Low Back Outcome Score (LBOS).
3. 3.To compare association of PET/CT associated parameters with post intervention clinical response associated parameters.
4. 4.Group A: Patients receiving F-18 sodium fluoride PET/CT-guided corticosteroid plus local anesthetic injection.
5. 5.Group B: Patients receiving Ultrasound-guided corticosteroid plus local anesthetic injection

Conditions

Chronic Low Back Pain

Keywords

Backache; F-18 Sodium Fluoride PET/CT; Pain Palliation; Facet Joint Pain; Chronic low backache; Sacroiliac Joint Pain; Chronic Low back pain

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (3)

• Correlation between baseline SUVmax and improvement in Visual Analog Scale (VAS) score

  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

  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)

  From baseline F-18 sodium fluoride PET/CT to follow up PET/CT and clinical assessment at 20 weeks

Study Arms (2)

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

Procedure: intra-articular injection

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

Procedure: intra-articular injection

Interventions

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

F-18 Sodium Fluoride Guided intra-articular Injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead

Study Sites (1)

Post Graduate Institute of Medical Education Research, Chandigarh

Chandigarh, Chandigarh, 160012, India

Location

MeSH Terms

Conditions

Back Pain

Interventions

Injections, Intra-Articular

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Injections; Drug Administration Routes; Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Additional Professor

Study Record Dates

• First Submitted: May 27, 2026
• First Posted: June 8, 2026
• Study Start: May 14, 2025
• Primary Completion: May 25, 2026
• Study Completion: May 25, 2026
• Last Updated: June 8, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)