Radiofrequency Ablation of the Superior Cluneal Nerve

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-01

Study Completion Date

2024-01-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Nerve Entrapment Syndrome Radiofrequency Ablation Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Radiofrequency ablation

Group Type OTHER

Radiofrequency ablation

Intervention Type 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.

conventional physical therapy

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No