Chronic Low Back PainPET-FACETNCT07632508
F-18 Sodium Fluoride PET/CT Guided Versus Ultrasound- Guided Intra-articular Injections in Chronic Low Backache
A study testing intra-articular injection in people with Chronic Low Back Pain, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- intra-articular injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIndia
- Study dates
- 14 May 2025to 25 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
India1 site
Post Graduate Institute of Medical Education Research, Chandigarh
Chandigarh, Chandigarh, 160012
About this study
Official title: 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.
Read more
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
- Conditions
- Chronic Low Back Pain
- Being tested
- intra-articular injection
- Keywords
- Backache, F-18 Sodium Fluoride PET/CT, Pain Palliation, Facet Joint Pain, Chronic low backache, Sacroiliac Joint Pain, Chronic Low back pain
- Medical subject headings
- Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intra-articular injectionProcedure or surgery
- 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 or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Procedure: intra-articular injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: From baseline F-18 sodium fluoride PET/CT to follow up PET/CT and clinical assessment at 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study start14 May 2025
- Primary completion25 May 2026
- Study completion25 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rajender Kumar, Post Graduate Institute of Medical Education and Research, Chandigarh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07632508
- Sponsor's protocol ID
- INT/IEC/2025/SPL-1127
- Acronym
- PET-FACET
- Status last verified
- Jun 2026
- First submitted
- 27 May 2026
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07632508
- Acronym / sponsor ID
- PET-FACET / INT/IEC/2025/SPL-1127
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Study start
- 14 May 2025 (actual)
- Primary completion
- 25 May 2026 (actual)
- Study completion
- 25 May 2026 (actual)
- First posted
- 8 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| F-18 Sodium Fluoride Guided intra-articular Injection | Active comparator | Procedure: intra-articular injectionPatients in this group will PET/CT guided intra articular block of the facet joint or sacroiliac joint using local anesthetic and corticosteroid |
| Ultrasound Guided Pain Palliation | Active comparator | Procedure: intra-articular injectionPatients in this group will undergo ultrasound-guided (USG) intra articular block of the facet joint or sacroiliac joint using local anesthetic and corticosteroid |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 or surgery | F-18 Sodium Fluoride Guided intra-articular Injection |
| intra-articular injectionA 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 | Procedure or surgery | Ultrasound Guided Pain Palliation |
Primary outcome
Change in Visual Analog Scale (VAS) Score
Time frame: 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.
Change in Oswestry Disability Index (ODI)
Time frame: 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.
Change in Low Back Outcome Score (LBOS)
Time frame: 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.
3 secondary outcomes
Correlation between baseline SUVmax and improvement in Visual Analog Scale (VAS) score
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
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)
Time frame: From baseline F-18 sodium fluoride PET/CT to follow up PET/CT and clinical assessment at 20 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intra-articular injection in people with Chronic Low Back Pain, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Visual Analog Scale (VAS) Score (time frame: From date of intervention to follow up at 20 weeks.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.