Radiofrequency Ablation of the Superior Cluneal Nerve

Not Applicable

Completed

• Conditions: Nerve Entrapment Syndrome; Radiofrequency Ablation; Low Back Pain
• Interventions: Procedure: Radiofrequency ablation

• Registration Number: NCT06240000
• Lead Sponsor: Ankara City Hospital Bilkent

Brief Summary

Low back pain is one of the most common musculoskeletal disorders affects individuals at least one during lifetime. Chronic low back pain (CLBP) lasts more than 3 months and decreases quality of life and causes work loss all over the world. Most common causes of Chronic Low back pain (CLBP) are lumbar disc herniation and/or degeneration, degenerative facet joints and sacroiliac joint pathologies, However, superior cluneal nerve (SCN) entrapment is another cause of CLBP that is ignored. It was reported that Superior cluneal nerve entrapment prevalence is % 1,6 - % 14 in CLBP patients. The Cluneal Nerves originate from the cutaneous branches of the dorsal ramus at T11-L4 and SCN innervates the skin of the upper part of the gluteal region. The nerves pass over the iliac crest through a tunnel formed by the thoracolumbar fascia and the upper edge of the iliac crest, that is the entrapment area. There are methods such as nerve blocks, neuromodulations and surgery in resistant cases. However, SCN entrapment is an overlooked diagnosis that should be considered in differential diagnosis.

Recently, radiofrequency ablation (RFA) of the SCN was performed under fluoroscopic guidance, total of 78% of patients reported nearly full analgesia for an average of 3 months. Although ultrasound-guided imaging and blocking of SCN is well described, there was not enough study that shows the effectiveness of ultrasound-guided SCN RFA and compares it to conventional physical therapy (CPT) in the treatment of CLBP.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-01
• Primary Completion: 2023-12-01
• Status Verified: 2024-01
• Study Completion: 2024-01-01
• Study First Submitted: 2024-01-08
• Study First Submitted QC: 2024-01-24
• Last Update Submitted: 2024-01-24
• Study First Posted: 2024-02-02
• Last Update Posted: 2024-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

1. Suffering from chronic low back pain more than 3 months
2. Age ≥ 18
3. VAS score ≥ 3/10
4. According to the blood samples, there should not be any detected bleeding diathesis (INR ≤1.2)
5. Patients detected positive 'iliac crest sign' included in the study

Exclusion Criteria

1. Patients have pain score <3 according to the Visual Analog Scale (VAS)
2. INR >1.2 in blood samples
3. Radicular pain accompanying progressive neurological deficit
4. Sphincter disorder due to neurologic conditions
5. Local infections
6. Sepsis
7. Malignancy
8. Uncontrolled diabetes or other comorbidities leading general condition disorders
9. Allergic history related to used materials
10. Pregnancy
11. Mental disorders worsen cooperation were excluded from the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Radiofrequency ablation	Radiofrequency ablation	-

Primary Outcome Measures

Name	Time	Method
Visual analog Scale	Evaluated at baseline (pre-treatment), 2 weeks and 3 months after treatment completed	Ten cm visual analog scale (VAS) was used by patients to perform a self-assessment of pain intensity associated with back pain. Higher scores indicate worse pain situations.

Secondary Outcome Measures

Name	Time	Method
Short-Form 36	Evaluated at baseline (pre-treatment), 2 weeks and 3 months after treatment completed	The Short Form-36 (SF-36) is used to assess health related quality of life. The SF-36 consists of 36 items in mental and physical parts. Physical role, emotional role, physical function, energy/vitality, mental health, social function, pain, and general health are subgroups of the assessment. Scores range from 0 to 100, with higher scores indicating a better health-related quality of life. The Turkish validity and reliability of the SF-36 has previously been studied.
Oswestry Disability Index	Evaluated at baseline (pre-treatment), 2 weeks and 3 months after treatment completed	Index evaluating disability and functionality due to lumbar conditions consists of 10 self reported items. All questions are scored from 0-5. Higher scores indicates higher disability levels according to low back pain.

Trial Locations

Locations (1)

Ankara Bilkent City Hospital; 🇹🇷 Ankara, Turkey