ClinicalTrials.gg
Status unknownNCT06469905Updated Jun 24, 2024

Erector Spina Plan Block in Patients With Lumbar Disc Herniation

An interventional study of Erector Spina Plan Block and Stabilization exercises in Low Back Pain, sponsored by Firat University. Status unknown at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-06-24.

Sponsored by Firat University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2024), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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).

Read the detailed description

Low back pain is defined as pain in the lower back and/or legs that negatively affects comfort. Low back pain lasting less than 6 weeks is defined as acute, 6-12 weeks as subacute, and more than 12 weeks as chronic low back pain. The goals of the exercise program include reducing pain, strengthening weak muscles, stretching tense muscles, reducing mechanical stress on spinal structures, mobilizing hypomobile segments and stabilizing hypermobile segments. 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. 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. 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).

02

Conditions studied

  • Low Back Pain

Keywords

  • Low back pain
  • Erector spina plane block
  • Exercise
03

In context

Low Back Pain

2,875 studies on the registry are indexed under Low Back Pain; 484 are open to participants now.

This study's planned enrollment of 30 is below the median of 60 across 2,315 interventional studies indexed under Low Back Pain.

Browse Low Back Pain studies →

Lead sponsor

Firat University is the lead sponsor of 117 studies on the registry; 46 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 18-50 years old
  • Patients diagnosed with disc herniation by clinical, physical examination and MR imaging
  • Low back pain for >6 weeks

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Single (Outcomes assessor)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Erector Spina Plan Block group

    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 Block · Other: Stabilization exercises

  • Experimental
    Stabilization exercises group

    Stabilization exercises will be practiced to control group

    Other: Stabilization exercises

Interventions

  • DeviceErector Spina Plan Block

    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.

  • OtherStabilization exercises

    Stabilization exercises will be practiced to control group

06

What researchers measure

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.

    Time frame: 2 minutes

Secondary outcomes

  1. Pain assessment

    Pain intensity will be assessed with a 10 cm Visuel Analog Scale (VAS). Patients are told what the numbers mean on the horizontal line, 0 means no pain, 10 means the most severe pain encountered in life, 5 means moderate pain and they are asked to describe the intensity of their pain on the scale.

    Time frame: 1 minute

07

Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06469905
Lead sponsor
Firat University
Responsible party
Songül Bağlan Yentür (Head of Physiotherapy and Rehabilitation Department, Firat University) — Principal investigator
First posted
Jun 24, 2024
Start date
Jun 20, 2024 (estimated)
Primary completion
Aug 20, 2024 (estimated)
Completion
Sep 20, 2024 (estimated)
Last update
Jun 24, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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