Clinical trial NCT04329598: Effects of Whole-Body Electromyostimulation Application in Individuals With Lumbar Disc Hernia
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lumbar Disc Herniation
Keywords: Whole body electromyostimulation
Lumbar disc herniation
Balance
Pain
Physical Conformity Parameters
Quality of Life
Lead sponsor: Eastern Mediterranean University
Sponsor class: OTHER
First posted: 2020-04-01
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A Comparative Study
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Y Balance test
timeFrame: 8 weeks
measure: Static balance evaluation
timeFrame: 8 weeks
Secondary outcomes:
measure: Oswestry Disability Index
timeFrame: 8 weeks
measure: Pain assessment
timeFrame: 8 weeks
measure: Muscle strengtening test
timeFrame: 8 weeks
measure: Muscle endurance test
timeFrame: 8 weeks
measure: Muscle shortness test
timeFrame: 8 weeks
measure: Evaluation of flexibility
timeFrame: 8 weeks
measure: Assessment of quality of life
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Famagusta
country: Cyprus
facility: Eastern Mediterranean Üniversity
city: Famagusta
country: Cyprus
facility: Eastern Mediterranean Üniversity
Study officials:
affiliation: Eastern Mediterranean University
name: Alp Esrefoglu, PT
role: PRINCIPAL_INVESTIGATOR
affiliation: Eastern Mediterranean University
name: Ender Angın, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.