Clinical trial NCT05560165: PET/CT Guided Robotic Arm-assisted Pain Palliation in Chronic Nociceptive Low Backache
Official title: F-18 Sodium Fluoride PET/CT Guided Robotic Arm-assisted Pain Palliation in Chronic Nociceptive Low Backache
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low-back Pain
Nociceptive Pain
Lead sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh
Sponsor class: OTHER
First posted: 2022-09-29
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Diagnostic efficacy of the procedure
timeFrame: Immediate - post procedure
measure: Treatment efficacy of the procedure
timeFrame: One month
Secondary outcomes:
measure: Safety of F-18 sodium fluoride PET/CT guided robotic arm assisted injection of local anesthetic and steroids.
timeFrame: Immediately following the procedure till 30 minutes and upto one month following the procedure
measure: Imaging based response assessment following F-18 sodium fluoride PET/CT guided robotic arm assisted injection of local anesthetic and steroids.
timeFrame: One month
Other outcomes:
Locations:
city: Chandigarh
country: India
facility: Department of Nuclear Medicine, Post Graduate Institute of Medical Education and Research
Study officials:
References: