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

Chronic Low-back Pain Clinical Trial

Official title: F-18 Sodium Fluoride PET/CT Guided Robotic Arm-assisted Pain Palliation in Chronic Nociceptive Low Backache

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

Chronic pain in the lower back may be due to a variety of causes such as neuropathic causes, musculoskeletal causes, visceral causes, malignancy-related or primary pain where in there is no obvious cause of pain. Musculoskeletal pain usually affects the muscles, joints, bones or their surrounding soft tissue structures. These participants are usually evaluated with clinical examination and radiological imaging modalities such as computed tomography (CT) or Magnetic resonance imaging (MRI) to identify the pain generating site. The possible sites of involvement may include the sacroiliac joints, intervertebral facet joints, the vertebrae, the intervertebral discs, or the surrounding ligaments and muscles which may be apparent on imaging. They are usually started on oral analgesics such as Non-steroidal anti-inflammatory drugs as the first line of management. However, occasionally the patient may not respond to this line of management. In such cases, they may be treated with more potent analgesics or subjected to targeted local management of the pain-generating site with an injection of local anesthetics and corticosteroids. They are usually given at the site of tenderness following clinical examination or under image guidance using x-ray fluoroscopy or CT guidance. However, anatomical imaging modalities may not diagnose early stages of the disease or distinguish active from inactive disease. Bone scintigraphy with Tc-99m labeled phosphonates is known to diagnose and localize active sites of musculoskeletal pain. PET/CT with sodium fluoride is also useful in the same indication as it has similar pharmacodynamics to that of Tc-99m labeled phosphonates. The combination of image guidance with sodium fluoride PET/CT and the use of an automated robotic arm (ARA) can help in the targeted delivery of the local anesthetic and steroids to the nociceptive pain generating site. This study is intended to analyze 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 steroid and local anesthetic for pain palliation in such participants. ;

Related Conditions & MeSH terms

• Chronic Low-back Pain
• Low Back Pain
• Nociceptive Pain

• NCT number: NCT05560165
• Study type: Interventional
• Source: Postgraduate Institute of Medical Education and Research
• Contact: Rajender Kumar, MD
• Phone: +91-172-2756722
• Email: drrajender2010@gmail.com
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2022
• Completion date: December 31, 2022