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Lumbar Disc HerniationNCT04329598

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

A study testing Whole-Body Electromyostimulation Group and Exercise Group in people with Lumbar Disc Herniation, run by Eastern Mediterranean University at 2 sites in Cyprus.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Lumbar Disc Herniation
What is being tested?
Whole-Body Electromyostimulation Group and Exercise Group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
2 sitesCyprus
Study dates
2 Sep 2021to 17 Dec 2021
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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

Cyprus2 sites

  • Eastern Mediterranean Üniversity

    Famagusta, 99450

  • Eastern Mediterranean Üniversity

    Famagusta

Other trials in Cyprus

About this study

Official title: 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.

Read the 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.

Being tested
Whole-Body Electromyostimulation Group, Exercise Group
Keywords
Whole body electromyostimulation, Lumbar disc herniation, Balance, Pain, Physical Conformity Parameters, Quality of Life
Medical subject headings
Intervertebral Disc Displacement, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Whole-Body Electromyostimulation GroupOther

    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.

  • Exercise GroupOther

    Exercise group includes exercises without electric stimulation. Exercise group will have 45 minutes of exercises which are specific exercises for Lumbar Disc Herniation.

Study groups in NCT04329598
Study groupRoleWhat they receive
Whole-Body Electromyostimulation GroupExperimentalWhole-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.
Receives: Other: Whole-Body Electromyostimulation Group
Exercise GroupExperimentalExercise group includes exercises without electric stimulation. Exercise group will have 45 minutes of exercises which are specific exercises for Lumbar Disc Herniation.
Receives: Other: Exercise Group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Y Balance test

    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.

    Measured: 8 weeks

  2. Static balance evaluation

    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.

    Measured: 8 weeks

Secondary outcomes (7)

  1. Oswestry Disability Index

    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.

    Measured: 8 weeks

  2. Pain assessment

    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.

    Measured: 8 weeks

  3. Muscle strengtening test

    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.

    Measured: 8 weeks

  4. Muscle endurance test

    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.

    Measured: 8 weeks

  5. Muscle shortness test

    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

    Measured: 8 weeks

  6. Evaluation of flexibility

    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

    Measured: 8 weeks

  7. Assessment of quality of life

    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.

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Apr 2020
  2. Study start2 Sep 2021
  3. Primary completion25 Oct 2021
  4. Study completion17 Dec 2021

Resources

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
Model description
A Comparative Study
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04329598
Sponsor's protocol ID
2019/23-07
Status last verified
Mar 2022
First submitted
30 Mar 2020
Last updated
31 Mar 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Kemmler W, Weissenfels A, Willert S, Shojaa M, von Stengel S, Filipovic A, Kleinoder H, Berger J, Frohlich M. Efficacy and Safety of Low Frequency Whole-Body Electromyostimulation (WB-EMS) to Improve Health-Related Outcomes in Non-athletic Adults. A Systematic Review. Front Physiol. 2018 May 23;9:573. doi: 10.3389/fphys.2018.00573. eCollection 2018.

    PubMed 29875684

  • Kemmler W, Weissenfels A, Bebenek M, Frohlich M, Kleinoder H, Kohl M, von Stengel S. Effects of Whole-Body Electromyostimulation on Low Back Pain in People with Chronic Unspecific Dorsal Pain: A Meta-Analysis of Individual Patient Data from Randomized Controlled WB-EMS Trials. Evid Based Complement Alternat Med. 2017;2017:8480429. doi: 10.1155/2017/8480429. Epub 2017 Oct 18.

    PubMed 29234437

  • Weissenfels A, Teschler M, Willert S, Hettchen M, Frohlich M, Kleinoder H, Kohl M, von Stengel S, Kemmler W. Effects of whole-body electromyostimulation on chronic nonspecific low back pain in adults: a randomized controlled study. J Pain Res. 2018 Sep 20;11:1949-1957. doi: 10.2147/JPR.S164904. eCollection 2018.

    PubMed 30288089

Questions about this trial

What is this clinical trial studying?

A study testing Whole-Body Electromyostimulation Group and Exercise Group in people with Lumbar Disc Herniation, run by Eastern Mediterranean University at 2 sites in Cyprus.

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 5 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 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Cyprus. 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?

Y Balance test (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04329598, which also lists 3 linked publications.

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 31 Mar 2022.

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