NCT04329598

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 1, 2020

Completed
1.4 years until next milestone

Study Start

First participant enrolled

September 2, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 25, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 17, 2021

Completed
Last Updated

March 31, 2022

Status Verified

March 1, 2022

Enrollment Period

2 months

First QC Date

March 30, 2020

Last Update Submit

March 30, 2022

Conditions

Keywords

Whole body electromyostimulationLumbar disc herniationBalancePainPhysical Conformity ParametersQuality of Life

Outcome Measures

Primary Outcomes (2)

  • 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.

    8 weeks

  • 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.

    8 weeks

Secondary Outcomes (7)

  • Oswestry Disability Index

    8 weeks

  • Pain assessment

    8 weeks

  • Muscle strengtening test

    8 weeks

  • Muscle endurance test

    8 weeks

  • Muscle shortness test

    8 weeks

  • +2 more secondary outcomes

Study Arms (2)

Whole-Body Electromyostimulation Group

EXPERIMENTAL

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

Exercise Group

EXPERIMENTAL

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

Interventions

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.

Whole-Body Electromyostimulation Group

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

Exercise Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Eastern Mediterranean Üniversity

Famagusta, 99450, Cyprus

Location

Eastern Mediterranean Üniversity

Famagusta, Cyprus

Location

Related Publications (3)

  • 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.

    PMID: 29875684BACKGROUND
  • 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.

    PMID: 29234437BACKGROUND
  • 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.

    PMID: 30288089BACKGROUND

MeSH Terms

Conditions

Intervertebral Disc DisplacementPain

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Alp Esrefoglu, PT

    Eastern Mediterranean University

    PRINCIPAL INVESTIGATOR
  • Ender Angın, PhD

    Eastern Mediterranean University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A Comparative Study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist

Study Record Dates

First Submitted

March 30, 2020

First Posted

April 1, 2020

Study Start

September 2, 2021

Primary Completion

October 25, 2021

Study Completion

December 17, 2021

Last Updated

March 31, 2022

Record last verified: 2022-03

Locations