Radiofrequency Ablation of the Superior Cluneal Nerve

NCT06240000 | Completed

• 1 other identifier: ankarasehir.kam@saglik.gov.tr
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Nerve Entrapment Syndrome; Radiofrequency Ablation; Low Back Pain

Keywords

Nerve Entrapment Syndrome; Radiofrequency Ablation; Low back pain

Outcome Measures

Primary Outcomes (1)

• Visual analog Scale

  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.

  Evaluated at baseline (pre-treatment), 2 weeks and 3 months after treatment completed

Secondary Outcomes (2)

• Oswestry Disability Index

  Evaluated at baseline (pre-treatment), 2 weeks and 3 months after treatment completed

• Short-Form 36

  Evaluated at baseline (pre-treatment), 2 weeks and 3 months after treatment completed

Study Arms (2)

Radiofrequency ablation

OTHER

Procedure: Radiofrequency ablation

conventional physical therapy

NO INTERVENTION

Interventions

Radiofrequency ablation PROCEDURE

Firstly, the posterior superior iliac spine was showed in the transverse plane, and it was gradually moved proximally until gluteus maximus muscle disappears and gluteus medius arises. Medial branch of the SCN is seen between iliac crest and thoracolumbar fascia as an ovoid structure. Radiofrequency device was utilized with 22-gauge 10-cm, 5 mm RF cannulas for all procedures. Cannula was placed thorough the SCN area and Sensory fiber stimulation was started between 0.3 and 0.5 V. The patient was asked for feedback on symptoms such as numbness, paresthesia or pain. If the patient did not report any sensory symptoms within the specified sensory stimulation range, the cannula was repositioned. Motor stimulation was given up to 1.5 V and it was checked whether there was any contraction or not. If there is no contraction detected, the SCN was ablated at 42° degrees centigrade for 240 seconds.

Radiofrequency ablation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, 00680, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 35500974 RESULT

• 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.

  PMID: 35430676 RESULT

• 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.

  PMID: 37395948 RESULT

MeSH Terms

Conditions

Charcot-Marie-Tooth Disease; Low Back Pain

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Hereditary Sensory and Motor Neuropathy; Nervous System Malformations; Nervous System Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: January 8, 2024
• First Posted: February 2, 2024
• Study Start: April 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: January 1, 2024
• Last Updated: February 2, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: It will become available for 6 months after submitting

Locations

TU (1)