Radiofrequency Ablation of the Superior Cluneal Nerve

Low Back Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06240000
• Other study ID #: ankarasehir.kam@saglik.gov.tr
• Status: Completed
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: January 1, 2024

Study information

• Verified date: January 2024
• Source: Ankara City Hospital Bilkent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: January 1, 2024
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Charcot-Marie-Tooth Disease
• Hereditary Sensory and Motor Neuropathy
• Low Back Pain
• Nerve Compression Syndromes
• Nerve Entrapment Syndrome
• Radiofrequency Ablation

Intervention

Procedure:
• Radiofrequency ablation
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.

Locations

Country	Name	City	State
Turkey	Ankara Bilkent City Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Ankara City Hospital Bilkent

Country where clinical trial is conducted

Turkey, 

References & 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 — View 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/s40122-02 — View 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/s1324 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Oswestry Disability Index	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.	Evaluated at baseline (pre-treatment), 2 weeks and 3 months after treatment completed
Secondary	Short-Form 36	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.	Evaluated at baseline (pre-treatment), 2 weeks and 3 months after treatment completed