- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06240000
Radiofrequency Ablation of the Superior Cluneal Nerve
Comparison of the Effectiveness of Radiofrequency Ablation of the Superior Cluneal Nerve and Conventional Physical Therapy in Patients With Chronic Low Back Pain
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Ankara, Turkey, 00680
- Ankara Bilkent City Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: 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.
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No Intervention: conventional physical therapy
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual analog Scale
Time Frame: 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.
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Evaluated at baseline (pre-treatment), 2 weeks and 3 months after treatment completed
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Oswestry Disability Index
Time Frame: 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.
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Evaluated at baseline (pre-treatment), 2 weeks and 3 months after treatment completed
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Short-Form 36
Time Frame: 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.
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Evaluated at baseline (pre-treatment), 2 weeks and 3 months after treatment completed
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Pain
- Neurologic Manifestations
- Congenital Abnormalities
- Genetic Diseases, Inborn
- Neuromuscular Diseases
- Neurodegenerative Diseases
- Peripheral Nervous System Diseases
- Heredodegenerative Disorders, Nervous System
- Nervous System Malformations
- Polyneuropathies
- Back Pain
- Low Back Pain
- Nerve Compression Syndromes
- Charcot-Marie-Tooth Disease
- Hereditary Sensory and Motor Neuropathy
Other Study ID Numbers
- ankarasehir.kam@saglik.gov.tr
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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