Comparison of the Effectiveness of Radiofrequency Ablation of the Superior Cluneal Nerve and Conventional Physical Therapy in Patients With Chronic Low Back Pain
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Ankara City Hospital Bilkent
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Visual analog Scale
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Suffering from chronic low back pain more than 3 months
- •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
- •Uncontrolled diabetes or other comorbidities leading general condition disorders
- •Allergic history related to used materials
- •Mental disorders worsen cooperation were excluded from the study.
Arms & Interventions
Radiofrequency ablation
Intervention: Radiofrequency ablation (Procedure)
conventional physical therapy
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Short-Form 36(Evaluated at baseline (pre-treatment), 2 weeks and 3 months after treatment completed)
- Oswestry Disability Index(Evaluated at baseline (pre-treatment), 2 weeks and 3 months after treatment completed)
Investigators
Hüma Bölük Şenlikci
Associate Professor
Ankara City Hospital Bilkent