Clinical trial NCT06298747: Ultrasound-guided Selective Cervical Root Pulsed Radiofrequency Therapy in Patients With Cervical Radicular Pain
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervical Pain
Keywords: cervical radicular pain
ultrasonography
cervical nerve root
pulsed radiofrequency
analgesia
Lead sponsor: Diskapi Teaching and Research Hospital
Sponsor class: OTHER
First posted: 2024-03-07
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with cervical radicular pain unresponsive to conservative treatments

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: VAS
timeFrame: Change from Baseline VAS at 6 months
Secondary outcomes:
measure: Neck Disability Index (NDI)
timeFrame: Change from Baseline NDI at 6 months
measure: Douleur Neuropathique 4 Questions (DN4)
timeFrame: Change from Baseline NDI at 6 months
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Etlik City Hospital
Study officials:
affiliation: Diskapi Teaching and Research Hospital
name: Ömer Taylan Akkaya, MD
role: STUDY_DIRECTOR
References: