Efficacy of the Erector Spinae Plane Block for Persistent Back Pain in Patients With Ankylosing Spondylitis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorMarmara University
About this trial
Despite adequate control of disease activity with standard medical therapies, there remains an ongoing need for complementary and interventional approaches for the management of persistent back pain in patients with ankylosing spondylitis. Although the erector spinae plane block has been described in the literature as a safe and effective analgesic intervention for chronic back pain in various patient populations, to the best of our knowledge, no clinical study has specifically evaluated its use for persistent back pain in patients with ankylosing spondylitis receiving medical treatment. Therefore, the present study aims to evaluate the effects of erector spinae plane block on pain severity and clinical outcomes in patients with ankylosing spondylitis whose disease activity is controlled under treatment but who continue to experience persistent back pain.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age between 18 and 65 years
Diagnosis of ankylosing spondylitis according to the Modified New York Criteria
Patients receiving ongoing treatment with controlled disease activity but persistent back pain
Willingness to participate in the study
Disqualifiers
Body mass index (BMI) greater than 35 kg/m²
History of thoracic surgery
Intellectual disability or mental retardation
Presence of major psychiatric comorbidity
Trial design
Design model
Single group
Treatments tested in this trial
Erector spinae plane block(ESBP)
Procedure/SurgeryThe procedure will be performed in the prone position under sterile conditions and ultrasound guidance. Using a 22-gauge needle at the T5-T7 vertebral levels, the fascial plane between the deep fascia of the erector spinae muscle group and the transverse process of the vertebra will be accessed. A combination consisting of 5 cc of 0.5% bupivacaine, 4 cc of 0.9% normal saline, and 1 cc dexamethasone (8 mg/2 mL) will then be injected into the targeted plane. The procedure will be performed by experienced algology specialists with more than 15 years of experience in ultrasound-guided interventional procedures and will be administered in two sessions within one week.
Treatment groups
15 Participants
are divided into 1 treatment groupGroup A: Patients with ankylosing spondylitis and resistant persistent back pain who underwent erector spinaeActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Numeric Rating Scale (NRS)
The Numeric Rating Scale is used to assess and monitor pain severity. On the scale, "0" indicates no pain, whereas "10" represents the worst pain imaginable. Patients are asked to rate their pain intensity on a scale ranging from 0 to 10. Due to its simplicity and ease of understanding, the NRS is widely used in clinical practice and research.
Time frame
Assessments will be performed at baseline (T0), 2 weeks after the erector spinae plane block procedure (T1), and 2 months after the procedure (T2).Secondary outcomes
1
Bath Ankylosing Spondylitis Metrology Index (BASMI)
BASMI is an index used to objectively assess spinal mobility in ankylosing spondylitis through physical examination measurements, including cervical rotation, tragus-to-wall distance, lateral spinal flexion, modified Schober test, and intermalleolar distance. BASMI scores range from 0 to 10, with higher scores indicating clinically significant restriction of spinal mobility and greater structural involvement.
Time frame
Assessments will be performed at baseline (T0), 2 weeks after the erector spinae plane block procedure (T1), and 2 months after the procedure (T2).2
Ankylosing Spondylitis Disease Activity Score-C-Reactive Protein (ASDAS-CRP)
ASDAS-CRP is a composite index used to assess disease activity in ankylosing spondylitis (AS) and axial spondyloarthritis by combining patient-reported outcomes with the objective inflammatory marker C-reactive protein (CRP). An ASDAS-CRP score ≥2.1 is considered indicative of active disease.
Time frame
Assessments will be performed at baseline (T0), 2 weeks after the erector spinae plane block procedure (T1), and 2 months after the procedure (T2).3
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
BASDAI is a patient-reported outcome measure used to assess disease activity in ankylosing spondylitis and axial spondyloarthritis. It consists of six questions evaluating fatigue, spinal pain, peripheral joint pain, enthesitis, and morning stiffness experienced during the previous week. BASDAI scores range from 0 to 10, with scores \<4 indicating low disease activity and scores ≥4 indicating clinically significant active disease. A BASDAI score of ≥4 is widely accepted as an important threshold for treatment decision-making and therapeutic escalation.
Time frame
Assessments will be performed at baseline (T0), 2 weeks after the erector spinae plane block procedure (T1), and 2 months after the procedure (T2).4
Bath Ankylosing Spondylitis Functional Index (BASFI)
BASFI is a patient-reported outcome measure consisting of 10 questions designed to evaluate functional capacity and activities of daily living in patients with ankylosing spondylitis. BASFI scores range from 0 to 10, with higher scores indicating clinically significant functional limitation and a greater impact of the disease on daily life.
Time frame
Assessments will be performed at baseline (T0), 2 weeks after the erector spinae plane block procedure (T1), and 2 months after the procedure (T2).Sponsors and contacts
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Source ClinicalTrials.gov