Erector Spina Plan Block in Patients With Lumbar Disc Herniation

June 21, 2024 updated by: Songül Bağlan Yentür, Firat University

Effects of Erector Spina Plan Block and Exercise in Patients With Lumbar Disc Herniation

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
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.
Other: Stabilization exercises
Stabilization exercises will be practiced to control group
Experimental: Stabilization exercises group
Stabilization exercises will be practiced to control group
Other: Stabilization exercises
Stabilization exercises will be practiced to control group

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Disability assessment
Time Frame: 2 minutes
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pain assessment
Time Frame: 1 minute
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.
1 minute

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Firat University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 20, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 20, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 20, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 14, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 21, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 24, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 24, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 21, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2024/06-39

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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