Ultrasound-guided Selective Cervical Root Pulsed Radiofrequency Therapy in Patients With Cervical Radicular Pain

NCT06298747 | Completed

• 1 other identifier: Cervical root PRF
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic cervical pain is a common disorder with a prevalence of approximately 35% in adults. Cervical radicular pain is defined as radiating pain in the upper limb caused by compression or inflammation of the nerve roots ascending from the intervertebral foramen to the spinal cord, due to disc herniation or spinal stenosis. C7 and C6 are the two most commonly affected nerve roots. Various treatment modalities are available, including oral medications, physiotherapy, and epidural steroid injections. However, chronic and persistent pain that develops as a result of some patients not responding to these treatments. Ultrasound-guided selective cervical nerve root block and pulsed radiofrequency are interventional treatments used in patients with radicular cervical pain unresponsive to conservative treatments. Pulsed radiofrequency (PRF) treatment of peripheral nerves may provide long-term pain relief in patients with short-term pain relief with a local anesthetic block. Studies have shown the effectiveness of PRF therapy applied to selective cervical nerve roots in relieving cervical radicular pain.

Conditions

Cervical Pain

Keywords

cervical radicular pain; ultrasonography; cervical nerve root; pulsed radiofrequency; analgesia

Outcome Measures

Primary Outcomes (1)

• VAS

  Visual analogue scales (VAS) are psychometric measuring instruments designed to document the characteristics of disease-related symptom severity in individual patients and use this to achieve a rapid (statistically measurable and reproducible) classification of symptom severity and disease control. (minimum value is 0 and maximum value is 10)

  Change from Baseline VAS at 6 months

Secondary Outcomes (2)

• Neck Disability Index (NDI)

  Change from Baseline NDI at 6 months

• Douleur Neuropathique 4 Questions (DN4)

  Change from Baseline NDI at 6 months

Study Arms (1)

Selective cervical nerve root pulsed radiofrequency

A 5-12 MHz linear US probe was used during the procedure. C7 has a more prominent posterior tubercle and a rudimentary anterior tubercle. C5 and C6 have more prominent and smooth anterior and posterior tubercles, respectively. After visualizing the hypoechoic nerve root between the tubercles of the transverse process, the surrounding vascular structures were identified and RF canula is used. After approaching the hypoechoic nerve root, after sensory and motor stimulation, PRF was applied to each nerve root with a current of 1.0-1.2 V at a frequency of 2 Hz for 4 minutes at 42 °C.

Other: Selective cervical nerve root pulsed radiofrequency

Interventions

Selective cervical nerve root pulsed radiofrequency OTHER

A 5-12 MHz linear US probe was used during the procedure. C7 has a more prominent posterior tubercle and a rudimentary anterior tubercle. C5 and C6 have more prominent and smooth anterior and posterior tubercles, respectively. After visualizing the hypoechoic nerve root between the tubercles of the transverse process, the surrounding vascular structures were identified and RF canula is used. After approaching the hypoechoic nerve root, after sensory and motor stimulation, PRF was applied to each nerve root.

Selective cervical nerve root pulsed radiofrequency

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with cervical radicular pain unresponsive to conservative treatments

You may qualify if:

• age ≥ 18 years
• radicular pain radiating only to the neck and one arm for more than 12 weeks
• no response to conservative treatment (including analgesics and physiotherapy modalities)
• access to clinical data

You may not qualify if:

• inadequate medical records with missing Numerical Rating Scale (NRS), Neck Disability Index (NDI), and DN4 (Douleur Neuropathique 4 Questions) scores
• patients lost to follow-up within six months after the procedure
• history of malignancy

Sponsors & Collaborators

• Diskapi Teaching and Research Hospital: lead

Study Sites (1)

Ankara Etlik City Hospital

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Neck Pain; Agnosia

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Ömer Taylan Akkaya, MD

  Diskapi Teaching and Research Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: March 1, 2024
• First Posted: March 7, 2024
• Study Start: November 1, 2022
• Primary Completion: July 1, 2023
• Study Completion: July 2, 2023
• Last Updated: March 15, 2024

Record last verified: 2024-03

Locations

TU (1)