F-18 Sodium Fluoride PET/CT Guided Versus Ultrasound- Guided Intra-articular Injections in Chronic Low Backache (PET-FACET)
2. juni 2026 oppdatert av: 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:
- 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.
- To compare functional improvement and disability outcomes between two study arms using Oswestry Disability Index (ODI) and Low Back Outcome Score (LBOS).
- 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
- Group A: Patients receiving F-18 sodium fluoride PET/CT-guided corticosteroid plus local anesthetic injection.
- Group B: Patients receiving Ultrasound-guided corticosteroid plus local anesthetic injection
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
40
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Chandigarh
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Chandigarh, Chandigarh, India, 160012
- Post Graduate Institute of Medical Education Research, Chandigarh
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-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: 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
|
• 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
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
|
|
Aktiv komparator: 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
|
• 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
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
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Visual Analog Scale (VAS) Score
Tidsramme: 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)
Tidsramme: 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
|
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Change in Low Back Outcome Score (LBOS)
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Correlation between baseline SUVmax and improvement in Visual Analog Scale (VAS) score
Tidsramme: From baseline F-18 Sodium fluoride PET/CT to follow up PET/CT and clinical assessment at 20 weeks
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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
Tidsramme: 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)
Tidsramme: 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
|
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Studierekorddatoer
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Studer hoveddatoer
Studiestart (Faktiske)
14. mai 2025
Primær fullføring (Faktiske)
25. mai 2026
Studiet fullført (Faktiske)
25. mai 2026
Datoer for studieregistrering
Først innsendt
27. mai 2026
Først innsendt som oppfylte QC-kriteriene
2. juni 2026
Først lagt ut (Faktiske)
8. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
8. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
2. juni 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- INT/IEC/2025/SPL-1127
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