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

Cervical Pain Clinical Trial

— pulsedrf  

Official title:

Evaluation of the Efficacy of Ultrasound-guided Selective Cervical Root Pulsed Radiofrequency Therapy in Patients With Cervical Radicular Pain: Analysis of Single-Center Data

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06298747
• Other study ID #: Cervical root PRF
• Status: Completed
• Start date: November 1, 2022
• Est. completion date: July 2, 2023

Study information

• Verified date: March 2024
• Source: Diskapi Teaching and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Pulsed radiofrequency treatment applied to selective cervical nerve roots (C5, C6, and C7) under ultrasound guidance is frequently used in patients with cervical radicular pain due to cervical disc herniation who do not respond adequately to medical treatment and physiotherapy. Pain intensity was evaluated at baseline and 1,3 and 6 months after US-guided selective cervical nerve root PRF treatment using VAS (Visual analog scale). The primary outcome measure was percent reduction in pain, with 50% pain relief lasting at least 6 months was defined as a positive categorical outcome. Patients' functionality and neuropathic pain status were assessed using the Neck Disability Index (NDI) and Douleur Neuropathique 4 Questions (DN4) at baseline and 1,3 and 6 months after US-guided selective cervical nerve root PRF treatment, respectively. Secondary outcome measure was defined as a positive categorical outcome of 50% or more improvement in these scores for at least 6 months. In addition, demographic data such as age (years), gender, duration of pain (months), pain side (right or left), affected cervical nerve root level (one or multiple levels), and history of surgery for cervical disc herniation and analgesic use (nonsteroidal anti-inflammatory drugs or opioids) were obtained from patient data and retrospectively analyzed the patient's electronic medical history records. The primary aim of this study was to determine the efficacy of US-SCNR PRF treatment, and the clinical and demographic variables associated with treatment outcomes. The secondary aim of this study was to determine the improvement in functionality and neuropathic pain status of patients after the procedure, and treatment-related adverse events.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: July 2, 2023
• Est. primary completion date: July 1, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Cervical Pain
• Neck Pain

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Turkey	Ankara Etlik City Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Diskapi Teaching and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Neck Disability Index (NDI)	NDI is a self-report questionnaire that measures the impact of neck pain on patient's daily activities and quality of life. It consists of ten items assessing pain intensity, self-care, lifting, reading, headache, concentration, work, driving, sleep, and leisure. Each item is scored between 0 and 5, with higher scores indicating more disability.	Change from Baseline NDI at 6 months
Secondary	Douleur Neuropathique 4 Questions (DN4)	The DN4 scale provides information on whether pain has a neuropathic character. It is scored according to the presence of burning, coldness, or electric shock sensation in the pain, tingling, numbness, stinging, or itching sensation in the same region, presence of touch or needle hypoesthesia on examination, and occurrence of pain in the same region with a brush. Although the maximum score was 10, a score >4 indicated the presence of neuropathic pain.	Change from Baseline NDI at 6 months