Disk Herniated LumbarNCT05233254
The Effect of Abdominal Hallowing on Coactivation of Lower Extremity Muscles in Patients With Lumbal Disc Herniation
A study testing Abdominal Hollowing exercise in people with Disk Herniated Lumbar and Coordination Lack, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Intervertebral disc degenerations are the most important cause of chronic low back pain resulting in job loss and associated socio-economic problems in developed and developing industrial countries 1. More than 40% of the Turkish population has experienced low back pain at least once in their life 2. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Disk Herniated Lumbar, Coordination Lack, Muscle Weakness
- What is being tested?
- Abdominal Hollowing exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2022to 30 May 2022
- 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
- Being between the ages of 18-65
- To be diagnosed with LDH at the minimum level of protrusion by the physician
- Diagnosis confirmed by the physician in charge of the study by computed tomography (CT) or magnetic resonance imaging (MRI) reports
Who cannot join
- Having bilateral LDH findings,
- have an acute illness
- Having significant neurological disease other than LDH (such as head trauma, brain abscess, brain tumor, migraine attack, seizure)
- Having trauma or congenital orthopedic disorders that prevent lower extremity functions other than LDH
- Not being able to adapt to the study cognitively.
Trial locations and contacts
1 site in 1 country.
About this study
Intervertebral disc degenerations are the most important cause of chronic low back pain resulting in job loss and associated socio-economic problems in developed and developing industrial countries 1. More than 40% of the Turkish population has experienced low back pain at least once in their life 2. Intervertebral disc degenerations Lumbal Disc Herniation (LDH), which is frequently represented, can cause motor and sensory losses in the lower extremity by compressing the spinal nerves. Lumbar disc surgery procedure is inevitable in case of advanced functional losses in the related sensory dermatomes and muscles after LDH. Lumbal disc surgeries are performed for the purpose of decompression of nerve pressures on nerves due to advanced disc herniation. they suggest 4.
One of the most common LDH problems in the community is low foot problems due to weakness of the tibialis anterior muscle, which occurs due to L4-L5 disc herniation, and the accompanying functional disorders. In disc herniations at this level, the activation of the tibialis anterior muscle, which is compressed by the nerve root, decreases compared to the medial gastrocnemius muscle, where it works as an antagonist, and this leads to functional limitations, especially in gait and balance activities.
Read more
Spinal stabilization exercises are a concept that emerged from the idea that exercise is important for the provision and preservation of functionality of people with low back and back pain due to LDH. According to this exercise approach, muscles are of great importance in providing lumbar region stability. These muscles are classified as general (global) stabilizing muscles, which are dynamic, phasic, and power-producing muscles, and regional (local) stabilizing muscles, which are postural, tonic, and stabilizer muscles. The main muscles responsible for spine stabilization are multifidus, transversus abdominus and pelvic floor muscles 6. It is argued that increased lumbo-pelvic motor control thanks to spine stabilization facilitates lower extremity activities, especially flexion and extension movements in the sagittal plane. Patients with LDH who increase their motor strength can use lower extremity movements more functionally.
The aim of this study was to (1) determine the activation rates of the tibialis anterior and medial gastrocnemius muscles during different functional activities in the lower extremities affected and unaffected by LDH, (2) to compare the rates of the affected extremity to the rates of the healthy extremity during coactivation of the transversus abdominus and multifidus muscles (spinal stabilization basic exercise). to determine whether it is close or not. According to the hypothesis of this study, the researchers thought that the functional activities performed together with the activation of the transversus abdominus and multifidus muscles would show coactivation behaviors at a rate closer to the healthy extremity.
- Conditions
- Disk Herniated Lumbar, Coordination Lack, Muscle Weakness
- Being tested
- Abdominal Hollowing exercise
- Keywords
- disc herniation, electromyography, muscle coactivation
- Medical subject headings
- Ataxia, Muscle Weakness, Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominal Hollowing exerciseBehavioural
Gently and slowly draw in your lower abdomen below your navel without moving your upper stomach, back and pelvis. Breathe in and out. Gently and slowly draw in your lower abdomen below your navel without moving your upper stomach, back and pelvis. Breathe in and out.
| Study group | Role | What they receive |
|---|---|---|
| Patients with L4-5 disc herniation | Experimental | In the light of the reference research, it was estimated that it could reach an effect size of 0.6 according to the sample size measurement made with at least 80% power and 0.05 margin of error, and 18 individuals with LDH (9 men, 9 women) were planned to participate in this study. Since data loss was predicted to be 20%, it was decided to include a total of 22 patients for the study. Receives: Behavioral: Abdominal Hollowing exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electromyography
The non-invasive superficial EMG system (Noraxon USA, Inc., Scottsdale, AZ) will be used to measure activation levels of the tibialis anterior and medial gastrocnemius muscles. Bipolar Ag/AgCl surface electrodes will be placed at intervals of 1 cm and 2 mm between the electrodes. The bandwidth of the processed EMG signals is 20-450 Hz. and input impedances will be limited to greater than 10 mV. The processing rate of EMG data is 1000 Hz. It will be determined.
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2022
- Study start1 Mar 2022
- Primary completion15 Apr 2022
- Study completion30 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disk Herniated LumbarStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ceyhun Turkmen, Çankırı Karatekin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05233254
- Sponsor's protocol ID
- 09-11-2021/23
- Status last verified
- Jun 2022
- First submitted
- 1 Feb 2022
- Last updated
- 6 Jun 2022
- Results posted
- No
- Data monitoring committee
- 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 6 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Abdominal Hallowing on Coactivation of Lower Extremity Muscles in Patients With Lumbal Disc Herniation
- ClinicalTrials.gov ID
- NCT05233254
- Acronym / sponsor ID
- 09-11-2021/23
- Conditions
- Disk Herniated Lumbar, Coordination Lack, Muscle Weakness
- Keywords
- disc herniation, electromyography, muscle coactivation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 15 Apr 2022 (actual)
- Study completion
- 30 May 2022 (actual)
- First posted
- 10 Feb 2022 (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.
Intervertebral disc degenerations are the most important cause of chronic low back pain resulting in job loss and associated socio-economic problems in developed and developing industrial countries 1. More than 40% of the Turkish population has experienced low back pain at least once in their life 2. Intervertebral disc degenerations Lumbal Disc Herniation (LDH), which is frequently represented, can cause motor and sensory losses in the lower extremity by compressing the spinal nerves. Lumbar disc surgery procedure is inevitable in case of advanced functional losses in the related sensory dermatomes and muscles after LDH. Lumbal disc surgeries are performed for the purpose of decompression of nerve pressures on nerves due to advanced disc herniation. they suggest 4.
One of the most common LDH problems in the community is low foot problems due to weakness of the tibialis anterior muscle, which occurs due to L4-L5 disc herniation, and the accompanying functional disorders. In disc herniations at this level, the activation of the tibialis anterior muscle, which is compressed by the nerve root, decreases compared to the medial gastrocnemius muscle, where it works as an antagonist, and this leads to functional limitations, especially in gait and balance activities.
Spinal stabilization exercises are a concept that emerged from the idea that exercise is important for the provision and preservation of functionality of people with low back and back pain due to LDH. According to this exercise approach, muscles are of great importance in providing lumbar region stability. These muscles are classified as general (global) stabilizing muscles, which are dynamic, phasic, and power-producing muscles, and regional (local) stabilizing muscles, which are postural, tonic, and stabilizer muscles. The main muscles responsible for spine stabilization are multifidus, transversus abdominus and pelvic floor muscles 6. It is argued that increased lumbo-pelvic motor control thanks to spine stabilization facilitates lower extremity activities, especially flexion and extension movements in the sagittal plane. Patients with LDH who increase their motor strength can use lower extremity movements more functionally.
The aim of this study was to (1) determine the activation rates of the tibialis anterior and medial gastrocnemius muscles during different functional activities in the lower extremities affected and unaffected by LDH, (2) to compare the rates of the affected extremity to the rates of the healthy extremity during coactivation of the transversus abdominus and multifidus muscles (spinal stabilization basic exercise). to determine whether it is close or not. According to the hypothesis of this study, the researchers thought that the functional activities performed together with the activation of the transversus abdominus and multifidus muscles would show coactivation behaviors at a rate closer to the healthy extremity.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with L4-5 disc herniation | Experimental | Behavioral: Abdominal Hollowing exerciseIn the light of the reference research, it was estimated that it could reach an effect size of 0.6 according to the sample size measurement made with at least 80% power and 0.05 margin of error, and 18 individuals with LDH (9 men, 9 women) were planned to participate in this study. Since data loss was predicted to be 20%, it was decided to include a total of 22 patients for the study. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Being between the ages of 18-65
- To be diagnosed with LDH at the minimum level of protrusion by the physician
- Diagnosis confirmed by the physician in charge of the study by computed tomography (CT) or magnetic resonance imaging (MRI) reports
Key exclusion criteria (5 listed)
- Having bilateral LDH findings,
- have an acute illness
- Having significant neurological disease other than LDH (such as head trauma, brain abscess, brain tumor, migraine attack, seizure)
- Having trauma or congenital orthopedic disorders that prevent lower extremity functions other than LDH
- Not being able to adapt to the study cognitively.
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 |
|---|---|---|
| Abdominal Hollowing exerciseGently and slowly draw in your lower abdomen below your navel without moving your upper stomach, back and pelvis. Breathe in and out. Gently and slowly draw in your lower abdomen below your navel without moving your upper stomach, back and pelvis. Breathe in and out. | Behavioural | Patients with L4-5 disc herniation |
Primary outcome
Electromyography
Time frame: 15 minutes
The non-invasive superficial EMG system (Noraxon USA, Inc., Scottsdale, AZ) will be used to measure activation levels of the tibialis anterior and medial gastrocnemius muscles. Bipolar Ag/AgCl surface electrodes will be placed at intervals of 1 cm and 2 mm between the electrodes. The bandwidth of the processed EMG signals is 20-450 Hz. and input impedances will be limited to greater than 10 mV. The processing rate of EMG data is 1000 Hz. It will be determined.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Abdominal Hollowing exercise in people with Disk Herniated Lumbar and Coordination Lack, run by Hacettepe 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: finished, as of the sponsor's last update on 6 Jun 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electromyography (time frame: 15 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 6 Jun 2022; AzTrials last refreshed its copy on 7 Nov 2026.