Radiofrequency Ablation of the Superior Cluneal Nerve

Last updated: January 24, 2024
Sponsor: Ankara City Hospital Bilkent
Overall Status: Completed

Phase

N/A

Condition

Peripheral Neuropathy

Neuropathy

Chronic Pain

Treatment

Radiofrequency ablation

Clinical Study ID

NCT06240000
ankarasehir.kam@saglik.gov.tr
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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

Total Participants: 25
Treatment Group(s): 1
Primary Treatment: Radiofrequency ablation
Phase:
Study Start date:
April 01, 2023
Estimated Completion Date:
January 01, 2024

Connect with a study center

  • Ankara Bilkent City Hospital

    Ankara, 00680
    Turkey

    Site Not Available

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