PET/CT Guided Robotic Arm-assisted Pain Palliation in Chronic Nociceptive Low Backache

NCT05560165 | Completed

• 1 other identifier: INT/IEC/2022/SPL-888
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

Brief Summary

A study to investigate the role of F-18 sodium fluoride in localizing the pain generator in participants with chronic nociceptive musculoskeletal low back ache and to study the use of PET/CT guided robotic arm assisted injection for targeted injection of a combination of corticosteroid and local anesthetic for pain palliation.

Conditions

Chronic Low-back Pain; Nociceptive Pain

Outcome Measures

Primary Outcomes (2)

• Diagnostic efficacy of the procedure

  Diagnostic efficacy of F-18 sodium fluoride PET/CT for localizing the site of pain in patients with chronic nociceptive low back ache and assessing the reduction in pain following the procedure.The procedure will be believed as technically successful if there is a 50% decrease in the severity of pain following the procedure as assessed by the visual analogue score.

  Immediate - post procedure

• Treatment efficacy of the procedure

  Treatment efficacy of injection of a combination of corticosteroid and local anesthetic intraarticularly following localization by F-18 sodium fluoride PET/CT in patients with chronic nociceptive low back ache. The visual analog score will be used to document the sustained reduction in pain for one month following the procedure.

  One month

Secondary Outcomes (2)

• Safety of F-18 sodium fluoride PET/CT guided robotic arm assisted injection of local anesthetic and steroids.

  Immediately following the procedure till 30 minutes and upto one month following the procedure

• Imaging based response assessment following F-18 sodium fluoride PET/CT guided robotic arm assisted injection of local anesthetic and steroids.

  One month

Study Arms (1)

PET/CT guided injection of combination of local anesthetic and steroids.

EXPERIMENTAL

The F-18 Sodium fluoride (NaF) dose will be administered intravenously and the F-18 NaF PET/CT images will be reviewed, and the target nociceptive site will be determined on the basis of increased focal tracer uptake. The joint accessibility, location, and relation with the nearby vital organs will be assessed. The injection will be assisted using a dedicated automated robotic arm system. A combination of corticosteroids and local anesthetic will be injected.

Procedure: F-18 sodium fluoride PET/CT guided robotic arm assisted injection of combination of local anesthetic and steroids

Interventions

F-18 sodium fluoride PET/CT guided robotic arm assisted injection of combination of local anesthetic and steroids PROCEDURE

A surgical aseptic approach will be followed for the procedure. Local anesthesia of the skin and soft tissue at the entry site will be achieved by 1% lignocaine. A 23G lumbar puncture needle will be introduced and the real-time final placement of the needle will be confirmed with low dose CT (40 mA) fused with pre-procedure PET images. After confirming the real-time position, the local anesthetic and steroid injection (0.5ml of 0.5% Bupivacaine per joint and a total dose of 80mg of Methylprednisolone acetate divided equally based on the number of joints to be injected) will be injected intraarticularly and periarticularly around the target joint through the lumbar puncture needle. The skin entry site will be compressed manually to achieve hemostasis. The same procedure will be repeated if multiple joints are to be injected. After the procedure, patient vitals will be observed for thirty minutes in the recovery area and discharged in stable condition.

PET/CT guided injection of combination of local anesthetic and steroids.

Eligibility Criteria

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

You may qualify if:

• Participants with chronic nociceptive low back ache (for more than three months) do not have adequate pain relief with oral analgesics.
• Participants who are ready to give written informed consent for the procedure

You may not qualify if:

• MRI showing the neuropathic cause of pain with spinal cord or nerve root compression.
• Extensive bone or joint destruction and displacement such as spondylolisthesis or compression fractures of the vertebra.
• Imaging, clinical and hematological findings suggestive of infective/ malignant pathology.
• Patients with deranged coagulation profile
• Pregnant and lactating women

Sponsors & Collaborators

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

Study Sites (1)

Department of Nuclear Medicine, Post Graduate Institute of Medical Education and Research

Chandigarh, Chandigarh, 160012, India

Location

MeSH Terms

Conditions

Nociceptive Pain

Interventions

Steroids

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Nuclear Medicine,

Study Record Dates

• First Submitted: September 26, 2022
• First Posted: September 29, 2022
• Study Start: January 1, 2022
• Primary Completion: September 30, 2024
• Study Completion: December 31, 2024
• Last Updated: March 25, 2025

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Five years from the date of completion of the study.
• Access Criteria: Reasonable request to the principal investigator

Locations

IN (1)