Ankylosing Spondylitis (AS)NCT07633730
Efficacy of the Erector Spinae Plane Block for Persistent Back Pain in Patients With Ankylosing Spondylitis
A study testing Erector spinae plane block(ESBP) in people with Ankylosing Spondylitis (AS) and Back Pain, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ankylosing Spondylitis (AS), Back Pain, ESPB
- What is being tested?
- Erector spinae plane block(ESBP)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jun 2026to 2 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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.)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Marmara University Faculty of Medicine Pendik Training and Research Hospital
Istanbul, Pendik
Fatma B Akdağ, Research Assistant, +905374529660, fatma.betul820@gmail.com
About this study
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.
Read the 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.
- Conditions
- Ankylosing Spondylitis (AS), Back Pain, ESPB, Regional Anesthesia
- Being tested
- Erector spinae plane block(ESBP)
- Keywords
- ESPB, Erector Spinae Plane Block, Back Pain, Ankylosing Spondylitis, Persistent back pain, Regional anesthesia
- Medical subject headings
- Spondylitis, Ankylosing, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector spinae plane block(ESBP)Procedure or surgery
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 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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with ankylosing spondylitis and resistant persistent back pain who underwent erector spinae | Active comparator | Patients with ankylosing spondylitis whose disease activity is adequately controlled under medical treatment but who are referred due to persistent back pain will undergo erector spinae plane block. All assessments, including pain severity, disease activity, general functional status, and spinal mobility, will be performed at baseline (T0), 2 weeks after the procedure (T1), and 2 months after the procedure (T2). Receives: Procedure: Erector spinae plane block(ESBP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 (5)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
The Istanbul Low Back Pain Functional Scale was developed to evaluate the functional impact of low back pain on activities of daily living in patients with low back pain. The scale consists of 18 items, with total scores ranging from 0 to 18. Higher scores indicate clinically significant increases in functional limitation. In general, scores of 0-6 indicate mild, 7-12 moderate, and 13-18 severe functional impairment.
Measured: Assessments will be performed at baseline (T0), 2 weeks after the erector spinae plane block procedure (T1), and 2 months after the procedure (T2).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study start2 Jun 2026
- Primary completion2 May 2027 (estimated)
- Study completion2 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankylosing Spondylitis (AS)Studies of the same condition, open and under way.
- More trials run by Marmara UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fatma B Akdağ, Research Assistant, Principal investigator, Marmara University Faculty of Medicine ,Marmara University, Department of Physical Medicine and RehabilitationSavaş Şencan, Associate Professor, Study director, Algology Division, Department of Physical Medicine and Rehabilitation, Marmara University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07633730
- Sponsor's protocol ID
- 09.2026.607
- Status last verified
- Jun 2026
- First submitted
- 2 Jun 2026
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of the Erector Spinae Plane Block for Persistent Back Pain in Patients With Ankylosing Spondylitis
- ClinicalTrials.gov ID
- NCT07633730
- Acronym / sponsor ID
- 09.2026.607
- Conditions
- Ankylosing Spondylitis (AS), Back Pain, ESPB, Regional Anesthesia
- Keywords
- ESPB, Erector Spinae Plane Block, Back Pain, Ankylosing Spondylitis, Persistent back pain, Regional anesthesia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 2 Jun 2026 (actual)
- Primary completion
- 2 May 2027 (estimated)
- Study completion
- 2 Jun 2027 (estimated)
- First posted
- 8 Jun 2026 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with ankylosing spondylitis and resistant persistent back pain who underwent erector spinae | Active comparator | Procedure: Erector spinae plane block(ESBP)Patients with ankylosing spondylitis whose disease activity is adequately controlled under medical treatment but who are referred due to persistent back pain will undergo erector spinae plane block. All assessments, including pain severity, disease activity, general functional status, and spinal mobility, will be performed at baseline (T0), 2 weeks after the procedure (T1), and 2 months after the procedure (T2). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
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 |
|---|---|---|
| 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 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. | Procedure or surgery | Patients with ankylosing spondylitis and resistant persistent back pain who underwent erector spinae |
Primary outcome
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).
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.
5 secondary outcomes
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Individual participant dataSharing planned: No
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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.
Fatma B Akdağ, Research Assistant principal investigator
Marmara University Faculty of Medicine ,Marmara University, Department of Physical Medicine and Rehabilitation
Savaş Şencan, Associate Professor study director
Algology Division, Department of Physical Medicine and Rehabilitation, Marmara University Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Erector spinae plane block(ESBP) in people with Ankylosing Spondylitis (AS) and Back Pain, run by Marmara University 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 4 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: looking for participants now, as of the sponsor's last update on 8 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fatma B Akdağ, Research Assistant (+90 537 452 96 60, fatma.betul820@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jun 2026.