Lumbar Disc HerniationNCT05927051
Effects of Exercise in Lumbal Disc Herniation
A study testing Stabilization exercises, McKenzie exercises and Home exercises in people with Lumbar Disc Herniation, run by Firat University at 1 site in Turkey (Türkiye).
Trial summary
Lumbar disc herniation, which causes 5% of all low back pain, is the rupture of the annulus fibrosis in the intervertebral disc in the lumbar region and the protrusion of the nucleus pulposus at various degrees, and as a result, the spinal cord or the nerves arising from it are compressed.Aerobic exercise is one of… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lumbar Disc Herniation
- What is being tested?
- Stabilization exercises, McKenzie exercises and Home exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jul 2023to 20 Oct 2023
- 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
- Patients between the ages of 18 to 65
- Patients who have diagnosed with LDH
Who cannot join
- Patients who were pregnant
- diagnosed with malignancy
- had changes of medical treatment in the last 3 months
- had dysfunction that limited physical activity such as severe neurological impairment,
- immobility or cooperation deficits
- had regular exercise habit (minimally three days in a week)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Songül Bağlan Yentür
Elâzığ
Songül Bağlan Yentür
About this study
Official title: Comparison of Different Exercise Types in Patients With Lumbal Disc Herniation
Lumbar disc herniation, which causes 5% of all low back pain, is the rupture of the annulus fibrosis in the intervertebral disc in the lumbar region and the protrusion of the nucleus pulposus at various degrees, and as a result, the spinal cord or the nerves arising from it are compressed.Aerobic exercise is one of the most important elements in low back pain rehabilitation.Many studies have shown that individuals with low back pain have low muscle strength of the back extensors and flexors when compared to individuals who do not show symptoms, and that these muscles are strong and their aerobic fitness is high, minimizing trauma-related musculoskeletal damage.The aim of this study is to examine the effect of core stabilization exercises on functionality and core muscles in patients with LDH.
Read the detailed description
n general, low back pain is defined as pain that negatively affects comfort in the lower back and/or legs. Low back pain lasting less than 6 weeks is defined as acute, 6-12 weeks as subacute, and lasting longer than 12 weeks as chronic low back pain. Depending on the low back pain of the people, the activity level decreases and therefore aerobic fitness is negatively affected. As a result of this negative impact, chronic conditions pose a risk in terms of cardiovascular disease and lead to a decrease in work capacity. Therefore, aerobic exercise is one of the most important elements in low back pain rehabilitation. In our country, training on regular exercise habits and waist protection methods is very low. Most patients do not apply to health institutions unless symptoms become severe.Many studies have shown that individuals with low back pain have low muscle strength of the back extensors and flexors when compared to individuals who do not show symptoms, and that these muscles are strong and their aerobic fitness is high, minimizing trauma-related musculoskeletal damage.
Core stabilization and strengthening has been the subject of research in the 1980s. The purpose of these exercises is to increase trunk stability and aerobic capacity. It is used to find and maintain the neutral position, to reduce ligament, tendon and joint tension, to reduce the load on discs and facet joints, to increase functional stability in low back pain, disc herniation and post-operative rehabilitation of patients.The researchers' studies have shown that ultrasound imaging is reliable in measuring TrA thickness in both healthy subjects and low back patients.
The aim of this study is to examine the effect of core stabilization exercises on functionality and core muscles in patients with LDH.
- Conditions
- Lumbar Disc Herniation
- Being tested
- Stabilization exercises, McKenzie exercises, Home exercises
- Keywords
- Lumbar Disc Herniation, McKnezie exercises, stabilization exercises
- Medical subject headings
- Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stabilization exercisesOther
Core stability exercises will be performed three days in a week. Treatment will continue an hour in per session for 8 weeks.
McKenzie exercisesOther
McKenzie exercises will be performed three days in a week. Treatment will continue an hour in per session for 8 weeks.
Home exercisesOther
Home exercises will be performed three days in a week. Treatment will continue an hour in per session for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Stabilization exercises | Experimental | Core stability exercises will be performed three days in a week. Treatment will continue an hour in per session for 8 weeks. Receives: Other: Stabilization exercises |
| McKenzie exercises | Experimental | McKenzie exercises will be performed three days in a week. Treatment will continue an hour in per session for 8 weeks. Receives: Other: McKenzie exercises |
| Home exercises | Experimental | Home exercises will be performed three days in a week. Treatment will continue an hour in per session for 8 weeks. Receives: Other: Home exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Core muscle thickness
Ultrasonographic images of the transversus abdominis (TrA), lumbar multifidus (MF) and Gluteus maximus (G max) muscles will be acquired using B mode (TOSHIBA Aplio 300, Japan).
Measured: 2 minutes
Secondary outcomes (2)
Visual Analog Scale
Pain Severity; It will be evaluated with a 10 cm Visual Analogue Scale (VAS). Patients are told what the numbers on the horizontal line mean, 0 is no pain, 10 is the most severe pain in life, and 5 is moderate pain, and they are asked to describe the severity of their pain on the scale.
Measured: 1 minute
Modified Oswerty Inquiry
Functional Disability Measurement; The evaluation will be made using the Turkish version of the Modified Oswestry Inquiry Form. Turkish validity and reliability were determined by Edibe Yakut et al. (2004) by In the evaluation of the Oswestry scale, scoring for each question is A=0 B=1 C=2 D=3 E=4 F=5 points. Questions that the patient does not answer will not be evaluated. Evaluation is made on the basis of the questions answered. Patient score =(Patient score/Maximum possible score)*100
Measured: 2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start20 Jul 2023 (estimated)
- Primary completion20 Sep 2023 (estimated)
- Study completion20 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Disc HerniationStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 15 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
- NCT05927051
- Sponsor's protocol ID
- 13-20
- Status last verified
- Jun 2023
- First submitted
- 23 Jun 2023
- Last updated
- 3 Jul 2023
- 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 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Different Exercise Types in Patients With Lumbal Disc Herniation
- ClinicalTrials.gov ID
- NCT05927051
- Acronym / sponsor ID
- 13-20
- Conditions
- Lumbar Disc Herniation
- Keywords
- Lumbar Disc Herniation, McKnezie exercises, stabilization exercises
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Firat UniversityUniversity, hospital or other
- Study start
- 20 Jul 2023 (estimated)
- Primary completion
- 20 Sep 2023 (estimated)
- Study completion
- 20 Oct 2023 (estimated)
- First posted
- 3 Jul 2023 (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.
Lumbar disc herniation, which causes 5% of all low back pain, is the rupture of the annulus fibrosis in the intervertebral disc in the lumbar region and the protrusion of the nucleus pulposus at various degrees, and as a result, the spinal cord or the nerves arising from it are compressed.Aerobic exercise is one of the most important elements in low back pain rehabilitation.Many studies have shown that individuals with low back pain have low muscle strength of the back extensors and flexors when compared to individuals who do not show symptoms, and that these muscles are strong and their aerobic fitness is high, minimizing trauma-related musculoskeletal damage.The aim of this study is to examine the effect of core stabilization exercises on functionality and core muscles in patients with LDH.
Detailed description
n general, low back pain is defined as pain that negatively affects comfort in the lower back and/or legs. Low back pain lasting less than 6 weeks is defined as acute, 6-12 weeks as subacute, and lasting longer than 12 weeks as chronic low back pain. Depending on the low back pain of the people, the activity level decreases and therefore aerobic fitness is negatively affected. As a result of this negative impact, chronic conditions pose a risk in terms of cardiovascular disease and lead to a decrease in work capacity. Therefore, aerobic exercise is one of the most important elements in low back pain rehabilitation. In our country, training on regular exercise habits and waist protection methods is very low. Most patients do not apply to health institutions unless symptoms become severe.Many studies have shown that individuals with low back pain have low muscle strength of the back extensors and flexors when compared to individuals who do not show symptoms, and that these muscles are strong and their aerobic fitness is high, minimizing trauma-related musculoskeletal damage.
Core stabilization and strengthening has been the subject of research in the 1980s. The purpose of these exercises is to increase trunk stability and aerobic capacity. It is used to find and maintain the neutral position, to reduce ligament, tendon and joint tension, to reduce the load on discs and facet joints, to increase functional stability in low back pain, disc herniation and post-operative rehabilitation of patients.The researchers' studies have shown that ultrasound imaging is reliable in measuring TrA thickness in both healthy subjects and low back patients.
The aim of this study is to examine the effect of core stabilization exercises on functionality and core muscles in patients with LDH.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Stabilization exercises | Experimental | Other: Stabilization exercisesCore stability exercises will be performed three days in a week. Treatment will continue an hour in per session for 8 weeks. |
| McKenzie exercises | Experimental | Other: McKenzie exercisesMcKenzie exercises will be performed three days in a week. Treatment will continue an hour in per session for 8 weeks. |
| Home exercises | Experimental | Other: Home exercisesHome exercises will be performed three days in a week. Treatment will continue an hour in per session for 8 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients between the ages of 18 to 65
- Patients who have diagnosed with LDH
Key exclusion criteria (6 listed)
- Patients who were pregnant
- diagnosed with malignancy
- had changes of medical treatment in the last 3 months
- had dysfunction that limited physical activity such as severe neurological impairment,
- immobility or cooperation deficits
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 |
|---|---|---|
| Stabilization exercisesCore stability exercises will be performed three days in a week. Treatment will continue an hour in per session for 8 weeks. | Other | Stabilization exercises |
| McKenzie exercisesMcKenzie exercises will be performed three days in a week. Treatment will continue an hour in per session for 8 weeks. | Other | McKenzie exercises |
| Home exercisesHome exercises will be performed three days in a week. Treatment will continue an hour in per session for 8 weeks | Other | Home exercises |
Primary outcome
Core muscle thickness
Time frame: 2 minutes
Ultrasonographic images of the transversus abdominis (TrA), lumbar multifidus (MF) and Gluteus maximus (G max) muscles will be acquired using B mode (TOSHIBA Aplio 300, Japan).
2 secondary outcomes
Visual Analog Scale
Time frame: 1 minute
Modified Oswerty Inquiry
Time frame: 2 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
- Optimizing performance by improving core stability and core strengthLink provided by the sponsor.
- Chapter 3. European guidelines for the management of acute nonspecific low back pain in primary careLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Lumbar Disc Herniation
Not yet recruiting
Cortical Surface Functional Changes After Lever Positioning Manipulation for Lumbar Disc Herniation
Lumbar Disc Herniation
Not yet recruiting
Effects of Spinal Mobilization With and Without Clinical Pilates in Patients With Lumbar Disc Herniationc Herniation
Disc Herniation
Enrolling by invitationObservational study
Intradiscal Ozone/Oxygen Injection for Treatment of Contained Lumbar Disc Herniation
Lumbar Disc Herniation
Not yet recruiting
Selective Nerve Root Block Versus Sham to Reduce Surgery for Lumbar Disc Herniation
Lumbar Disc Herniation, Lumbar Radiculopathy
Not yet recruiting
H-Reflex-Guided Direction-Sensitive Exercise Versus Standard Extension Exercise for Functional Recovery in Patients With Lumbar Disc Prolapse
Lumber Disc Prolapse
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 Stabilization exercises, McKenzie exercises and Home exercises in people with Lumbar Disc Herniation, 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 2 inclusion and 6 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 3 Jul 2023. 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?
Contact Songül Bağlan Yentür (+90 424 2370000, sbyentur@firat.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Core muscle thickness (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 3 Jul 2023.