search
Back to results

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

Primary Purpose

Disk Herniated Lumbar, Coordination Lack, Muscle Weakness

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Abdominal Hollowing exercise
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Disk Herniated Lumbar focused on measuring disc herniation, electromyography, muscle coactivation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

  • 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.

Sites / Locations

  • Çankırı Karatekin Üniversitesi

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients with L4-5 disc herniation

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
February 1, 2022
Last Updated
June 3, 2022
Sponsor
Hacettepe University
search

1. Study Identification

Unique Protocol Identification Number
NCT05233254
Brief Title
The Effect of Abdominal Hallowing on Coactivation of Lower Extremity Muscles in Patients With Lumbal Disc Herniation
Official Title
The Effect of Abdominal Hallowing on Coactivation of Lower Extremity Muscles in Patients With Lumbal Disc Herniation
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
April 15, 2022 (Actual)
Study Completion Date
May 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Disk Herniated Lumbar, Coordination Lack, Muscle Weakness
Keywords
disc herniation, electromyography, muscle coactivation

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients with L4-5 disc herniation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Abdominal Hollowing exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Electromyography
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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.
Facility Information:
Facility Name
Çankırı Karatekin Üniversitesi
City
Çankırı
ZIP/Postal Code
18100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs