Efficacy of the Erector Spinae Plane Block for Persistent Back Pain in Patients With Ankylosing Spondylitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Erector spinae plane block(ESBP).
- Who it may be relevant to
- Registry conditions: Ankylosing Spondylitis (AS), Back Pain, ESPB, Regional Anesthesia. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
Ankylosing spondylitis (AS) is a chronic inflammatory rheumatic disease primarily affecting the axial skeleton, including the spine and sacroiliac joints. The most prominent clinical manifestations of AS are chronic back pain and progressive spinal stiffness; however, the disease may also involve peripheral joints and entheses.
The primary goals in the management of AS are to reduce pain and stiffness, preserve functional capacity, and decrease overall disease burden. Nonsteroidal anti-inflammatory drugs (NSAIDs) constitute the first-line treatment, while biologic agents and disease-modifying antirheumatic drugs (DMARDs) are used in appropriate patients.
Back pain in AS represents one of the hallmark symptoms of the disease and mainly arises from inflammation involving the spine and sacroiliac joints. This symptom is frequently associated with functional impairment and reduced quality of life.
Although contemporary treatment strategies can effectively suppress disease activity in many patients, a subset of individuals continue to experience persistent symptoms and disease burden despite treatment, a condition commonly referred to as "residual disease." Residual symptoms are frequently reported even in patients achieving clinical remission or low disease activity, and a considerable proportion of these patients continue to suffer from ongoing pain. Therefore, persistent back pain despite controlled disease activity has emerged as an important unmet clinical need, potentially associated not only with inflammatory mechanisms but also with accompanying mechanical factors and comorbid conditions.
The erector spinae plane (ESP) block is a regional analgesic technique performed under ultrasound guidance by advancing the needle tip into the fascial plane deep to the erector spinae muscle at the level of the transverse process, followed by injection of local anesthetic and steroid agents. Owing to the cranio-caudal spread of the injectate, the ESP block can provide analgesia across multiple dermatomes. In patients with persistent back pain, ESP block has been described as a complementary interventional option administered at thoracic or lumbar levels, either as a single or repeated procedure depending on the clinical scenario, with the aims of reducing pain severity, improving functional status, and decreasing analgesic requirements. However, the current evidence remains limited for many chronic pain indications, consisting predominantly of case reports, case series, and a limited number of clinical studies.
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 adequately controlled under medical treatment but who continue to experience persistent back pain.
Interventions
- Procedure Erector spinae plane block(ESBP)
The 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 exp
Primary outcome measures
- Numeric Rating Scale (NRS) [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 outcome measures (5)
- Bath Ankylosing Spondylitis Metrology Index (BASMI) [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).]
- Ankylosing Spondylitis Disease Activity Score-C-Reactive Protein (ASDAS-CRP) [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).]
- Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) [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).]
- Bath Ankylosing Spondylitis Functional Index (BASFI) [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).]
- Istanbul Low Back Pain Functional Scale (ILBPFS) [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).]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- Body mass index (BMI) greater than 35 kg/m²
- History of thoracic surgery
- Intellectual disability or mental retardation
- Presence of major psychiatric comorbidity
- Congenital spinal anomaly
- Pregnancy
- History of bleeding diathesis
- Presence of active local and/or systemic infection
- Known allergy to the medications to be injected
- Hemodynamic instability
- Active phase of the disease (elevated acute phase reactants, active arthritis findings, etc.)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Turkey (Türkiye) · 1 center
- Marmara University Faculty of Medicine Pendik Training and Research Hospital — Istanbul
Identifiers
NCT: NCT07633730 · 09.2026.607