CompletedNot Applicable

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

India40 participantsStarted 2025-05-14

Plain-language 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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial compared two methods of guiding injections into the joints of the spine — one using a special PET/CT scan with a radioactive tracer called F-18 sodium fluoride, and the other using ultrasound — so can you explain which approach you currently use for my injections and whether the PET/CT-guided method might be relevant to my situation?
2Since this trial has already been completed and measured things like pain scores and disability levels, has any published data come out yet, and if so, did one guidance method show meaningfully better pain relief or function for patients with chronic low back pain like mine?
3The trial used a radioactive tracer for the PET/CT-guided injections, which is different from a standard ultrasound — can you walk me through what the radiation exposure would involve and whether that extra step is worth it compared to the ultrasound approach?
4This trial focused specifically on intra-articular injections, meaning injections directly into the spinal joints — is that type of injection something that makes sense for my specific diagnosis, or are there other treatment options I should consider first?
5Since this study is now completed, would you be able to refer me to a specialist or center that may already be applying what was learned from this trial, particularly if PET/CT-guided injections could help identify which of my joints are most active and worth treating?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Visual Analog Scale (VAS) Score

Timeframe: From date of intervention to follow up at 20 weeks.

Change in Oswestry Disability Index (ODI)

Timeframe: From date of intervention to the follow up at 20 weeks

Change in Low Back Outcome Score (LBOS)

Timeframe: From date of intervention to follow up at 20 weeks

Trial details

NCT IDNCT07632508

SponsorPost Graduate Institute of Medical Education and Research, Chandigarh

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-05-25

View on ClinicalTrials.gov More Chronic Low Back Pain trials