NCT06469905

Brief Summary

Erector Spina Plan Block (ESPB) is a technique used in surgical interventions, acute and chronic pain. The aim of this study was to investigate the effect of ESPB and core stabilization exercises on functionality in patients with Lumbal Disc Herniation. ESPB will be applied to the patients in the study group. Stabilization exercises will be applied together with ESPB treatment. Only stabilization exercises will be applied to the patients in the control group. Patients will be asked to complete a questionnaire inquiring sociodemographic data (age, height, weight, BMI, smoking and alcohol use), VAS and Modified Oswestry Questionnaire at initial presentation and after 8 weeks of exercise (8 weeks 3 days a week).

Trial Health

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Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable low-back-pain

Timeline
Completed

Started Jun 2024

Shorter than P25 for not_applicable low-back-pain

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

First Submitted

Initial submission to the registry

June 14, 2024

Completed
6 days until next milestone

Study Start

First participant enrolled

June 20, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 24, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2024

Completed
Last Updated

June 24, 2024

Status Verified

June 1, 2024

Enrollment Period

2 months

First QC Date

June 14, 2024

Last Update Submit

June 21, 2024

Conditions

Keywords

Low back painErector spina plane blockExercise

Outcome Measures

Primary Outcomes (1)

  • Disability assessment

    Functional Disability Measurement; Assessment will be made using the Turkish version of the Modified Oswestry Questionnaire. n the evaluation of the Oswestry scale, the scoring for each question is A=0 B=1 C=2 D=3 E=4 F=5 points.

    2 minutes

Secondary Outcomes (1)

  • Pain assessment

    1 minute

Study Arms (2)

Erector Spina Plan Block group

EXPERIMENTAL

ESPB will be applied to the patients in the study group. Stabilization exercises will be applied together with ESPB treatment. The needle will be inserted between the erector spinae muscle and the transverse process structures.The local anesthetic will be monitored to spread along the erector spinae muscle.

Device: Erector Spina Plan BlockOther: Stabilization exercises

Stabilization exercises group

EXPERIMENTAL

Stabilization exercises will be practiced to control group

Other: Stabilization exercises

Interventions

ESPB will be applied to the patients in the study group. Stabilization exercises will be applied together with ESPB treatment. The needle will be inserted between the erector spinae muscle and the transverse process structures.The local anesthetic will be monitored to spread along the erector spinae muscle.

Erector Spina Plan Block group

Stabilization exercises will be practiced to control group

Erector Spina Plan Block groupStabilization exercises group

Eligibility Criteria

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

You may qualify if:

  • years old
  • Patients diagnosed with disc herniation by clinical, physical examination and MR imaging
  • Low back pain for \>6 weeks

You may not qualify if:

  • Severe spinal stenosis
  • Diagnosis of pregnancy, infection or malignancy
  • Presence of systemic inflammatory rheumatic disease
  • Having neurological, orthopedic or congenital problems that prevent physical activity
  • History of spinal surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Songul Baglan Yentur

Elâzığ, 23100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Low Back PainMotor Activity

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Physiotherapy and Rehabilitation Department

Study Record Dates

First Submitted

June 14, 2024

First Posted

June 24, 2024

Study Start

June 20, 2024

Primary Completion

August 20, 2024

Study Completion

September 20, 2024

Last Updated

June 24, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations