Nerve Entrapment SyndromeNCT06240000
Radiofrequency Ablation of the Superior Cluneal Nerve
A study testing Radiofrequency ablation in people with Nerve Entrapment Syndrome and Radiofrequency Ablation, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Nerve Entrapment Syndrome, Radiofrequency Ablation, Low Back Pain
- What is being tested?
- Radiofrequency ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2023to 1 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Being tested
- Radiofrequency ablation
- Keywords
- Nerve Entrapment Syndrome, Radiofrequency Ablation, Low back pain
- Medical subject headings
- Charcot-Marie-Tooth Disease, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency ablationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Radiofrequency ablation | Other | Not described Receives: Procedure: Radiofrequency ablation |
| conventional physical therapy | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Evaluated at baseline (pre-treatment), 2 weeks and 3 months after treatment completed
Secondary outcomes (2)
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.
Measured: Evaluated at baseline (pre-treatment), 2 weeks and 3 months after treatment completed
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.
Measured: Evaluated at baseline (pre-treatment), 2 weeks and 3 months after treatment completed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2024
- Study start1 Apr 2023
- Primary completion1 Dec 2023
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Nerve Entrapment SyndromeStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hüma Bölük Şenlikci, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06240000
- Sponsor's protocol ID
- ankarasehir.kam@saglik.gov.tr
- Status last verified
- Jan 2024
- First submitted
- 8 Jan 2024
- Last updated
- 2 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After writing is complete and submitted the journal, individual participant data is going to be shared
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.
PubMed 35500974Visnjevac 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.
PubMed 35430676Wu 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.
PubMed 37395948
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06240000
- Acronym / sponsor ID
- ankarasehir.kam@saglik.gov.tr
- Keywords
- Nerve Entrapment Syndrome, Radiofrequency Ablation, Low back pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 2 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Radiofrequency ablation | Other | Procedure: Radiofrequency ablation |
| conventional physical therapy | No intervention | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiofrequency ablationFirstly, 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. | Procedure or surgery | Radiofrequency ablation |
Primary outcome
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.
2 secondary outcomes
Oswestry Disability Index
Time frame: Evaluated at baseline (pre-treatment), 2 weeks and 3 months after treatment completed
Short-Form 36
Time frame: Evaluated at baseline (pre-treatment), 2 weeks and 3 months after treatment completed
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2024.
- Results publication: PubMed 35500974Gautam 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.
- Results publication: PubMed 35430676Visnjevac 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.
- Results publication: PubMed 37395948Wu 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.
- Individual participant dataSharing planned: Yes. After writing is complete and submitted the journal, individual participant data is going to be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency ablation in people with Nerve Entrapment Syndrome and Radiofrequency Ablation, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analog Scale (time frame: Evaluated at baseline (pre-treatment), 2 weeks and 3 months after treatment completed). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06240000, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2024.