Ultrasound-Guided Proximal Superior Cluneal Nerve Block for Superior Cluneal Nerve Entrapment
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorGaziosmanpasa Research and Education Hospital
About this trial
Superior cluneal nerve entrapment (SCNE) is an underrecognized cause of chronic low back pain and gluteal pain that may mimic lumbar spine disorders. Ultrasound-guided proximal superior cluneal nerve block has increasingly been used in routine clinical practice .Diagnostic superior cluneal nerve block is commonly used to confirm the diagnosis, whereas ultrasound-guided proximal superior cluneal nerve block has emerged as a therapeutic option.
This prospective observational cohort study aims to evaluate the clinical outcomes of ultrasound-guided proximal superior cluneal nerve block in patients with clinically diagnosed superior cluneal nerve entrapment who undergo the procedure as part of routine clinical care. Pain intensity, disability, and neuropathic pain characteristics will be assessed at baseline and during follow-up to evaluate treatment outcomes.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18-75 years.
Chronic low back and/or gluteal pain persisting for at least 3 months.
Localized pain and/or tenderness over the posterior iliac crest.
At least 50% reduction in pain intensity following diagnostic superior cluneal nerve block.
Disqualifiers
Previous superior cluneal nerve surgery.
Active local or systemic infection.
Bleeding disorders or contraindications to the procedure.
Allergy to study medications.
Trial population
Adults with chronic low back and/or gluteal pain and a positive diagnostic superior cluneal nerve block response who undergo ultrasound-guided proximal superior cluneal nerve block as part of routine clinical care. Participants will be prospectively followed for clinical outcomes.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Ultrasound-Guided Proximal Superior Cluneal Nerve Block
Procedure/SurgeryUltrasound-guided proximal superior cluneal nerve block will be performed as part of routine clinical care in patients with clinically diagnosed superior cluneal nerve entrapment. The proximal superior cluneal nerve will be targeted using a standardized ultrasound-guided interfascial technique. A standardized injectate will be administered according to the study protocol. All procedures will be performed by an experienced pain physician using the same technique for all participants.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Patients With Superior Cluneal Nerve Entrapment Undergoing Ultrasound-Guided Proximal Superior Clune1 intervention
Trial outcomes
Primary outcomes
1
Change in Pain Intensity
Pain intensity will be assessed using the 11-point Numeric Rating Scale (NRS), a unidimensional pain assessment tool ranging from 0 (no pain) to 10 (the worst imaginable/unbearable pain). Patients will be asked to select the number that best reflects their pain intensity. The change in NRS pain score following ultrasound-guided proximal superior cluneal nerve block will be evaluated at the predefined follow-up time points.
Time frame
Baseline, 1 month, and 3 monthsSecondary outcomes
1
Change in Oswestry Disability Index (ODI) Score
Oswestry Disability Index (ODI): Change in disability related to low back pain assessed using the Oswestry Disability Index (ODI).The validated and reliability-tested Turkish version of the ODI will be used in this study.The ODI consists of 10 items, each scored from 0 to 5, yielding a maximum total raw score of 50.The total score is converted to a percentage using the following formula:ODI percentage = (Total score / 50) × 100 Higher percentage scores indicate greater disability. Disability levels are interpreted as follows: 0-20%: Minimal disability 21-40%: Moderate disability 41-60%: Severe disability 61-80%: Crippling disability 81-100%: Bed-bound or exaggerated symptoms A decrease in ODI percentage score indicates improvement in functional status. The change in ODI score following ultrasound-guided proximal superior cluneal nerve block will be evaluated at the predefined follow-up time points.
Time frame
Baseline, 1 month, and 3 months2
Douleur Neuropathique 4 (DN4)
Neuropathic pain will be assessed using the Douleur Neuropathique en 4 Questions (DN4) questionnaire, a validated 10-item screening tool with scores ranging from 0 to 10, where higher scores indicate a greater likelihood of neuropathic pain and a score of ≥4 is considered indicative of neuropathic pain. The change in DN4 score following ultrasound-guided proximal superior cluneal nerve block will be evaluated at the predefined follow-up time points.
Time frame
Baseline, 1 month, and 3 months3
Treatment Response
Treatment response will be defined as a ≥50% reduction in NRS pain score compared with baseline.
Time frame
1 month and 3 monthsSponsors and contacts
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Source ClinicalTrials.gov