Whole-Body Electromyostimulation Versus Therapeutic Resistance Exercise for the Treatment of Non-Specific Chronic Low Back Pain

NCT ID: NCT06642350

Last Updated: 2025-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-01

Study Completion Date

2025-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Non-specific chronic low back pain (NSCBP) is considered the leading cause of impairment of normal, symptom-free life (disability-adjusted life years - DALYs). NSCBP force more people out of work than diabetes, heart disease, hypertension, respiratory disease, asthma and cancer together. Strength and stability-oriented training programs in particular can lead to a significant improvement in NSCBP. However, back pain patients often cite time limitations and kinesiophobia (fear of movements) as the main reasons for their physical inactivity . The time-effective, joint-friendly and highly customizable whole-body electromyostimulation technology (WB-EMS) has been shown to be an effective alternative to conventional back training in two recently published clinical studies Following the successful implementation of this concept, dissemination of the positive results and testing of suitable settings for its implementation, the next step is to adapt and implement the concept as part of a knowledge transfer project in outpatient rehabilitation settings. The present project thus aimed to compare the effect of WB-EMS versus medical therapeutic therapy (MTT) using dedicated resistances devices as a recognized safe and effective treatment for low back pain.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Low Back Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Outcome assessors are unaware of participant status (WB-EMS or MTT) and were not allowed to ask participants correspondingly

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Whole-body electromyostimulation

WB-EMS 1.5x 20 min/week for 10 weeks

Group Type EXPERIMENTAL

Whole-body electrostimulation

Intervention Type OTHER

10 weeks of WB-EMS 1.5x 20 min/week

Medical training therapy (MTT)

MTT 2x 45 min/week for 10 weeks

Group Type ACTIVE_COMPARATOR

Medical Training Therapy

Intervention Type OTHER

10 weeks of MTT 2x 45 min/week

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Whole-body electrostimulation

10 weeks of WB-EMS 1.5x 20 min/week

Intervention Type OTHER

Medical Training Therapy

10 weeks of MTT 2x 45 min/week

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

WB-EMS MTT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* women and men 40-70 years old;
* chronic pain in the lumbar spine (at least 50 percent of the days of the last 3 months,
* average basal pain intensity (average 7 days) in the lumbar spine on NRS 0-10: ≥2.5

Exclusion Criteria

* orthopedic diagnosis (i.e. specific type of LBP);
* frequent intake of analgesics (\>4 days/week);
* pharmacological therapy or diseases affecting muscle metabolism (e.g., glucocorticoids);
* no contraindications for WB-EMS application (e.g., epilepsy, cardiac pacemaker, thrombosis, and total endoprosthesis)
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Erlangen-Nürnberg Medical School

OTHER

Sponsor Role lead

Rehamed Center Forchheim, Germany

UNKNOWN

Sponsor Role collaborator

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Wolfgang Kemmler, PhD

Role: PRINCIPAL_INVESTIGATOR

Institute of Radiology, University Hospital Nürnberg, Nürnberg, Germany

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Institute of Radiology, University Hospital Nürnberg

Erlangen, , Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

References

Explore related publications, articles, or registry entries linked to this study.

Micke F, Weissenfels A, Wirtz N, von Stengel S, Dormann U, Kohl M, Kleinoder H, Donath L, Kemmler W. Similar Pain Intensity Reductions and Trunk Strength Improvements Following Whole-Body Electromyostimulation vs. Whole-Body Vibration vs. Conventional Back-Strengthening Training in Chronic Non-specific Low Back Pain Patients: A Three-Armed Randomized Controlled Trial. Front Physiol. 2021 Apr 13;12:664991. doi: 10.3389/fphys.2021.664991. eCollection 2021.

Reference Type BACKGROUND
PMID: 33927646 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

WBEMS_Back_Outpatient

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.