Effects of Whole-Body Electromyostimulation Application in Individuals With Lumbar Disc Hernia

March 30, 2022 updated by: Alp Eşrefoğlu, Eastern Mediterranean University

The Effects of Whole-Body Electromyostimulation Application on Balance, Pain, Physical Conformity Parameters and Quality of Life in Individuals With Lumbar Disc Hernia: a Comperative Study

To determine the effects of WB-EMS application on balance, pain, muscle strength, muscle endurance, flexibility, muscle shortening and quality of life in individuals with Lumbar Disc Hernia and compare it with individuals who have not received this training.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Lumbar disc hernia (LDH); It is one of the common spinal problems that occur in the form of low back pain and radiculopathy that spreads to the lower extremities. The prevalence of lumbar disc herniation reported in individuals with low back pain; It ranges from 0% to 47%. It has been reported that the highest prevalence of LDH is in adults between the ages of 30-50. Disc herniation at the L4-5 and L5 - S1 spinal levels is more common in adults over the age of 55. The most important complaint in LDH is pain, and patients often complain of a blunt pain in the lumbar region. Weakness in the muscles surrounding the vertebra can cause balance and walking problems. For Lumbar Disc Hernia, sedentary life, gender, high body mass index, occupation, smoking, psychosocial factors and people exposed to vibration for a long time are among the risk factors. Lack of time is reported to be the biggest obstacle to exercising. In addition, kinesiophobia, that is the fear of pain due to movement, is very common in this group. Physical activity and exercise are arguably the most comprehensive therapeutic agent for a long-term and fundamentally established society. There is a consensus on the review of the current literature that it positively affects the risk of exercise disease, but not all, risk factors, diseases, and disability between middle and advanced age. Whole Body Electromyostimulation (WB-EMS), a technology that addresses nine (main) muscle groups, may be a good option. Given the low training intensity of 1-2 sessions per week for 20 sessions, it may be of interest to people who are close to traditional exercise programs, with low volunteer intensity and a high degree of oversight and individualization of existing WB-EMS settings.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Cyprus
      • Famagusta, Cyprus
        • Eastern Mediterranean University
      • Famagusta, Cyprus, 99450
        • Eastern Mediterranean University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Bulging or protruding disc herniation between L1-S1 levels diagnosed by the attending physician
  • Without a neurological sign
  • Not attending physiotherapy and rehabilitation session in the last 6 months
  • No regular exercise habits
  • No previous WB-EMS experience

Exclusion Criteria:

  • Use of muscle relaxants
  • Pain medication use
  • Pacemaker
  • Implants
  • Having a history of cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Whole-Body Electromyostimulation Group
Whole-Body Electromyostimulation group includes exercises with electric stimulation. Whole-Body Electromyostimulation group will have 45 minutes of exercises which are specific exercises for Lumbar Disc Herniation.
Other: Whole-Body Electromyostimulation Group
Whole-Body Electromyostimulation group includes exercises with electric stimulation. Whole-Body Electromyostimulation group will have 45 minutes of exercises which are specific exercises for Lumbar Disc Herniation.
Experimental: Exercise Group
Exercise group includes exercises without electric stimulation. Exercise group will have 45 minutes of exercises which are specific exercises for Lumbar Disc Herniation.
Other: Exercise Group
Exercise group includes exercises without electric stimulation. Exercise group will have 45 minutes of exercises which are specific exercises for Lumbar Disc Herniation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Y Balance test
Time Frame: 8 weeks
The assessor should place his fingers behind the line to stand on the platform and should be instructed to push the access indicator in the target area in the tested direction. After three attempts with each member in each direction, the evaluator checks whether the individual has performed at least one successful test. Otherwise, the evaluator will request an additional test until the interval is correct. This test is evaluating dinamic balance.
8 weeks
Static balance evaluation
Time Frame: 8 weeks
Both feet will be recorded for one-foot standing times for static balance assessment. Individuals will be asked to stand in one-foot standing position with their hands at the waist and stand for as long as they can. Each evaluation will be done in 3 replications and the best result will be recorded.
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oswestry Disability Index
Time Frame: 8 weeks
Oswestry Disability Index (ODi) was used to determine the degree of disability. ODI consists of 10 items that measure the severity of pain, personal care, lifting, walking, sitting, standing, social life, sleep and pain. Each item is rated between 0-5. As the total score increases, the level of disability increases. The maximum score is 50 points; 31-50 points are considered heavy, 11-30 points are moderate and 1-10 points are considered light. By converting the total score obtained from the patient to the percentile system, the percentage of disability will be calculated.
8 weeks
Pain assessment
Time Frame: 8 weeks
First Part: In this section, the patient is asked to mark the location of the pain on the body diagram and indicate "D" if the pain is coming deeply, "Y" on the body surface and "DY" on both the deep and the surface. Second Part: In this part, there are 20 sets of word groups that examine pain in terms of sensory, perceptual and evaluation. Each group consists of 2-6 words that describe pain with different aspects. The patient is told to select the word set that matches his pain and mark the word that matches his pain in the chosen set. The first 10 of the 20 word sets in the second part of the MASF include the sensory size of the pain, the next five clusters perceptual dimension, and the 16th set includes the assessment. The last four clusters are composed of words that show various aspects of pain. Part Three: This section includes the relationship of pain over time. There are groups of words to determine the continuity, frequency, and factors that increase / decrease pain.
8 weeks
Muscle strengtening test
Time Frame: 8 weeks
Hand Held Dynamometer is used to measure isometric muscle strength of upper limb, lower limb and trunk muscles. This measurement is repeated 2 times for each muscle and the average of the force at the time of their position deterioration is recorded in kilograms. This measurement was repeated 2 times for each direction and the average of the force at the moment the position was broken will be recorded in kilograms.
8 weeks
Muscle endurance test
Time Frame: 8 weeks
This test is performed to evaluate the endurance of the muscle group evaluated. After giving the appropriate position to the muscle group to be evaluated, the person is asked to protect as much as he can maintain that position and it is recorded in seconds.
8 weeks
Muscle shortness test
Time Frame: 8 weeks
With this test, muscle shortness will be evaluated. After giving the appropriate position to individuals, measurements will be taken using goniometer and tape measure and the data will be recorded. These muscles are pectoral muscle, hamstrings, hip flexor muscles, quadriceps and lumbar extensor muscles
8 weeks
Evaluation of flexibility
Time Frame: 8 weeks
Sit and reach test: The patients were asked to take a long sitting position on the floor. Metric scale placed on the tip of the soles of the foot in this position they were asked to reach forward on the scale found of cases the longest distance they can reach is noted in centimeters Trunk lateral flexion test: In measurement, feet are adjacent, arms are freely trunk measurement was made next to it. First, the outer surface of the thigh of the distal end of the right hand the place on it was determined, then sliding his hands down from the dancers they were asked to bend their body sideways. With the maximum point that cases can go The difference between the resting position is noted in centimeters. Measurement left repeated for the side
8 weeks
Assessment of quality of life
Time Frame: 8 weeks
Short Form-36 (SF-36) is a self-assessment scale and 36 items of 8 dimensions of health such as physical function, social function, role restrictions (due to physical and emotional causes), mental health, vitality (energy), pain and general perception of health.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eastern Mediterranean University

Investigators

  • Principal Investigator: Alp Esrefoglu, PT, Eastern Mediterranean University
  • Study Director: Ender Angın, PhD, Eastern Mediterranean University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 2, 2021

Primary Completion (Actual)

October 25, 2021

Study Completion (Actual)

December 17, 2021

Study Registration Dates

First Submitted

March 30, 2020

First Submitted That Met QC Criteria

March 30, 2020

First Posted (Actual)

April 1, 2020

Study Record Updates

Last Update Posted (Actual)

March 31, 2022

Last Update Submitted That Met QC Criteria

March 30, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019/23-07

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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