Clinical trial NCT06240000: Radiofrequency Ablation of the Superior Cluneal Nerve
Official title: Comparison of the Effectiveness of Radiofrequency Ablation of the Superior Cluneal Nerve and Conventional Physical Therapy in Patients With Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nerve Entrapment Syndrome
Radiofrequency Ablation
Low Back Pain
Keywords: Nerve Entrapment Syndrome
Radiofrequency Ablation
Low back pain
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2024-02-02
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This current prospective randomized study was carried out in Ankara Bilkent City Hospital, Department of Physical Therapy and Rehabilitation. Total of 25 CLBP patients (12 patients underwent SCN RFA, 13 patients participated CPT) were enrolled. Patients who admitted to outpatient clinics with low back pain that lasts more than 3 months, aged ≥ 18 year-old and detected positive 'iliac crest sign' included in the study. Patients have pain score \<3 according to the Visual Analog Scale (VAS), INR \>1.2 in blood samples were excluded from the study.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Visual analog Scale
timeFrame: Evaluated at baseline (pre-treatment), 2 weeks and 3 months after treatment completed
Secondary outcomes:
measure: Oswestry Disability Index
timeFrame: Evaluated at baseline (pre-treatment), 2 weeks and 3 months after treatment completed
measure: Short-Form 36
timeFrame: Evaluated at baseline (pre-treatment), 2 weeks and 3 months after treatment completed
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Bilkent City Hospital
Study officials:
References:
citation: Gautam S, Gupta N, Khuba S, Agarwal A, Kumar S, Das PK. Evaluation of the efficacy of Superior Cluneal Nerve Block in low back pain: A prospective observational study. J Bodyw Mov Ther. 2022 Apr;30:221-225. doi: 10.1016/j.jbmt.2022.03.001. Epub 2022 Mar 3.
citation: Visnjevac O, Pastrak M, Ma F, Visnjevac T, Abd-Elsayed A. Radiofrequency Ablation of the Superior Cluneal Nerve: A Novel Minimally Invasive Approach Adopting Recent Anatomic and Neurosurgical Data. Pain Ther. 2022 Jun;11(2):655-665. doi: 10.1007/s40122-022-00385-x. Epub 2022 Apr 17.
citation: Wu WT, Mezian K, Nanka O, Chen LR, Ricci V, Lin CP, Chang KV, Ozcakar L. Enhancing diagnosis and treatment of superior cluneal nerve entrapment: cadaveric, clinical, and ultrasonographic insights. Insights Imaging. 2023 Jul 3;14(1):116. doi: 10.1186/s13244-023-01463-0.