NCT07633730

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
12mo left

Started Jun 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress4%
Jun 2026Jun 2027

First Submitted

Initial submission to the registry

June 2, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

June 2, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 8, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 2, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 2, 2027

Last Updated

June 8, 2026

Status Verified

June 1, 2026

Enrollment Period

11 months

First QC Date

June 2, 2026

Last Update Submit

June 2, 2026

Conditions

Back PainAnkylosing Spondylitis (AS)ESPBRegional Anesthesia

Keywords

ESPBErector Spinae Plane BlockBack PainAnkylosing SpondylitisPersistent back painRegional anesthesia

Outcome Measures

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.

    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)

    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)

    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)

    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)

    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)

    Assessments will be performed at baseline (T0), 2 weeks after the erector spinae plane block procedure (T1), and 2 months after the procedure (T2).

Study Arms (1)

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).

Procedure: Erector spinae plane block(ESBP)

Interventions

Erector spinae plane block(ESBP)PROCEDURE

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.

Patients with ankylosing spondylitis and resistant persistent back pain who underwent erector spinae

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University Faculty of Medicine Pendik Training and Research Hospital

Istanbul, Pendik, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Spondylitis, AnkylosingBack Pain

Condition Hierarchy (Ancestors)

Axial SpondyloarthritisSpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesAnkylosisJoint DiseasesArthritisPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Fatma B Akdağ, Research Assistant

    Marmara University Faculty of Medicine ,Marmara University, Department of Physical Medicine and Rehabilitation

    PRINCIPAL INVESTIGATOR

  • Savaş Şencan, Associate Professor

    Algology Division, Department of Physical Medicine and Rehabilitation, Marmara University Faculty of Medicine

    STUDY DIRECTOR

Central Study Contacts

Fatma B Akdağ, Research Assistant

CONTACT

+90 537 452 96 60fatma.betul820@gmail.com

Savaş Şencan, Associate Professor

CONTACT

+90 537 066 57 13savas-44@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2026

First Posted

June 8, 2026

Study Start

June 2, 2026

Primary Completion (Estimated)

May 2, 2027

Study Completion (Estimated)

June 2, 2027

Last Updated

June 8, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)