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CompletedNCT05233254Updated Jun 6, 2022

The Effect of Abdominal Hallowing on Coactivation of Lower Extremity Muscles in Patients With Lumbal Disc Herniation

An interventional study of Abdominal Hollowing exercise in Disk Herniated Lumbar, Coordination Lack and Muscle Weakness, sponsored by Hacettepe University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-06-06.

Sponsored by Hacettepe University · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
17
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Disk Herniated Lumbar
  • Coordination Lack
  • Muscle Weakness

Keywords

  • disc herniation
  • electromyography
  • muscle coactivation
03

In context

Ataxia

299 studies on the registry are indexed under Ataxia; 51 are open to participants now.

This study's enrollment of 17 is below the median of 26 across 219 interventional studies indexed under Ataxia.

Browse Ataxia studies →

Lead sponsor

Hacettepe University is the lead sponsor of 1,001 studies on the registry; 215 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

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
17 participants (actual)

Study arms

  • Experimental
    Patients with L4-5 disc herniation

    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.

    Behavioral: Abdominal Hollowing exercise

Interventions

  • BehavioralAbdominal Hollowing exercise

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 15 minutes

07

Study locations

1 site
  • Çankırı Karatekin Üniversitesi
    Çankırı, 18100, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2022 to primary completion in Apr 2022, 1 month.

Of 83 non-industry interventional studies with no phase under Ataxia, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 33. This study's 1 month is below that.

Counting every sponsor, half of 86 studies reached it within 18 months; a quarter within 7 and three quarters within 30.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 1, 2022
First posted
Feb 10, 2022
StartActual
Mar 1, 2022
Primary completionActual
Apr 15, 2022
CompletionActual
May 30, 2022
Last update
Jun 6, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 6, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05233254
Responsible party
Ceyhun Turkmen (Asst. Prof., Çankırı Karatekin University) — Principal investigator
First posted
Feb 10, 2022
Start date
Mar 1, 2022
Primary completion
Apr 15, 2022
Completion
May 30, 2022
Last update
Jun 6, 2022

Oversight

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

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