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

2 juni 2026 bijgewerkt door: Rajender Kumar, Post Graduate Institute of Medical Education and Research, Chandigarh

F-18 Sodium Fluoride PET/CT Guided Pain Palliation in Chronic Low Backache : Comparing the Efficacy of Ultrasound - Guided Vs PET/CT Guided Intra-articular Injections of Corticosteroid and Local Anesthetic.

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

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

40

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Indië
    • Chandigarh
      • Chandigarh, Chandigarh, Indië, 160012
        • Post Graduate Institute of Medical Education Research, Chandigarh

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: F-18 Sodium Fluoride Guided intra-articular Injection
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
• 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
Procedure: intra-articular injection
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
Actieve vergelijker: Ultrasound Guided Pain Palliation
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
• 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
Procedure: intra-articular injection
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

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Visual Analog Scale (VAS) Score
Tijdsspanne: From date of intervention to follow up at 20 weeks.
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)
Tijdsspanne: From date of intervention to the follow up at 20 weeks
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)
Tijdsspanne: From date of intervention to follow up at 20 weeks
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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Correlation between baseline SUVmax and improvement in Visual Analog Scale (VAS) score
Tijdsspanne: From baseline F-18 Sodium fluoride PET/CT to follow up PET/CT and clinical assessment at 20 weeks
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.
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
Tijdsspanne: From baseline F-18 sodium fluoride PET/CT to follow up PET/CT and clinical assessment at 20 weeks
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)
Tijdsspanne: From baseline F-18 sodium fluoride PET/CT to follow up PET/CT and clinical assessment at 20 weeks
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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Post Graduate Institute of Medical Education and Research, Chandigarh

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

14 mei 2025

Primaire voltooiing (Werkelijk)

25 mei 2026

Studie voltooiing (Werkelijk)

25 mei 2026

Studieregistratiedata

Eerst ingediend

27 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

2 juni 2026

Eerst geplaatst (Werkelijk)

8 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

8 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

2 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • INT/IEC/2025/SPL-1127

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

product vervaardigd in en geëxporteerd uit de V.S.

Nee

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