Low Back PainNCT06469905
Erector Spina Plan Block in Patients With Lumbar Disc Herniation
A study testing Erector Spina Plan Block and Stabilization exercises in people with Low Back Pain, run by Firat University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Erector Spina Plan Block and Stabilization exercises
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jun 2024to 20 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- 18-50 years old
- Patients diagnosed with disc herniation by clinical, physical examination and MR imaging
- Low back pain for >6 weeks
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Songul Baglan Yentur
Elâzığ, 23100
Songul Baglan Yentur, 04242370000, songulbaglan23@hotmail.com
Songul Baglan Yentur, songulbaglan23@hotmail.com
About this study
Official title: 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).
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).
- Conditions
- Low Back Pain
- Being tested
- Erector Spina Plan Block, Stabilization exercises
- Keywords
- Low back pain, Erector spina plane block, Exercise
- Medical subject headings
- Low Back Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector Spina Plan BlockDevice
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.
Stabilization exercisesOther
Stabilization exercises will be practiced to control group
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Erector Spina Plan Block; Other: Stabilization exercises |
| Stabilization exercises group | Experimental | Stabilization exercises will be practiced to control group Receives: Other: Stabilization exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2024
- Study start20 Jun 2024 (estimated)
- Primary completion20 Aug 2024 (estimated)
- Study completion20 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Firat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Songül Bağlan Yentür, Firat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06469905
- Sponsor's protocol ID
- 2024/06-39
- Status last verified
- Jun 2024
- First submitted
- 14 Jun 2024
- Last updated
- 24 Jun 2024
- Results posted
- 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 24 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Erector Spina Plan Block and Exercise in Patients With Lumbar Disc Herniation
- ClinicalTrials.gov ID
- NCT06469905
- Acronym / sponsor ID
- 2024/06-39
- Conditions
- Low Back Pain
- Keywords
- Low back pain, Erector spina plane block, Exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Firat UniversityUniversity, hospital or other
- Study start
- 20 Jun 2024 (estimated)
- Primary completion
- 20 Aug 2024 (estimated)
- Study completion
- 20 Sep 2024 (estimated)
- First posted
- 24 Jun 2024 (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.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erector Spina Plan Block group | Experimental | Device: Erector Spina Plan Block, Other: Stabilization exercisesESPB 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. |
| Stabilization exercises group | Experimental | Other: Stabilization exercisesStabilization exercises will be practiced to control group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18-50 years old
- Patients diagnosed with disc herniation by clinical, physical examination and MR imaging
- Low back pain for >6 weeks
Key exclusion criteria (5 listed)
- 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
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 Spina Plan BlockESPB 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 group |
| Stabilization exercisesStabilization exercises will be practiced to control group | Other | Erector Spina Plan Block group, Stabilization exercises group |
Primary outcome
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.
1 secondary outcome
Pain assessment
Time frame: 1 minute
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2024.
- 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. This study is not recruiting at the moment.
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 Spina Plan Block and Stabilization exercises in people with Low Back Pain, run by Firat 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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 24 Jun 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disability assessment (time frame: 2 minutes). 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 24 Jun 2024.