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

January 29, 2026 updated by: University of Erlangen-Nürnberg Medical School

Whole-Body Electromyostimulation Versus Medical Therapeutic Training (MTT) Resistance Exercise for the Treatment of Non-Specific Chronic Low Back Pain in Middle-Aged to Older Cohort With Low-Back Pain.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

26

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

  • Germany
      • Erlangen, Germany, 91052
        • Institute of Radiology, University Hospital Nürnberg

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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)

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Whole-body electromyostimulation
WB-EMS 1.5x 20 min/week for 10 weeks
Other: Whole-body electrostimulation
10 weeks of WB-EMS 1.5x 20 min/week
Other Names:
  • WB-EMS
Active Comparator: Medical training therapy (MTT)
MTT 2x 45 min/week for 10 weeks
Other: Medical Training Therapy
10 weeks of MTT 2x 45 min/week
Other Names:
  • MTT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes of non-specific low back pain from baseline to 10 week follow-up assessment as determined by the numeric rating scale 0-10
Time Frame: From enrollment (baseline assessment) to the end of treatment at 10 weeks"
Numeric rating scale 1-10: Zero is equivalent to no pain and 10 indicates the worst possible pain."
From enrollment (baseline assessment) to the end of treatment at 10 weeks"

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes of disability from baseline to 10 week follow-up assessment as determine by the Roland Morris Disability Questionnaire (RMDQ)
Time Frame: From enrollment (baseline) to the end of treatment at 10 weeks"
RMDQ: 24-item Score that scored physical ability and activities of daily living (yes vs. no). The higher the score, the worse the patient's back-related functional status.
From enrollment (baseline) to the end of treatment at 10 weeks"
Changes of back extension strength from baseline to 10 week follow-up assessment as determined by the Dr. Wolf back-check device
Time Frame: "From enrollment (baseline assessment) to the end of treatment at 10 weeks"
Dr. Wolf back-check: Isometric test device for trunk strength
"From enrollment (baseline assessment) to the end of treatment at 10 weeks"
Changes of trunk flexion strength from baseline to 10 week follow-up assessment as determined by the Dr. Wolf back-check device
Time Frame: From enrollment (baseline assessment) to the end of treatment at 10 weeks"
Dr. Wolf Back check: Isometric test device for trunk strength
From enrollment (baseline assessment) to the end of treatment at 10 weeks"
Changes of lean body mass from baseline to 10 week assessment as determined by bio impedance assessment (BIA)
Time Frame: From enrollment (baseline assessment) to the end of treatment at 10 weeks
BIA: Assessment of lean body mass by direct-segmental multi-frequency bioimpedance analysis using InBody 770 (Seoul, Korea)
From enrollment (baseline assessment) to the end of treatment at 10 weeks
Changes of body fat from baseline to 10 week follow-up assessment as determine by bio impedance analysis
Time Frame: From enrollment (baseline assessment) to the end of treatment at 10 weeks
BIA: Assessment of lean body mass by direct-segmental multi-frequency bio impedance analysis using InBody 770 (Seoul, Korea)
From enrollment (baseline assessment) to the end of treatment at 10 weeks

Collaborators and Investigators

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

Sponsor

University of Erlangen-Nürnberg Medical School

Collaborators

Rehamed Center Forchheim, Germany

Investigators

  • Principal Investigator: Wolfgang Kemmler, PhD, Institute of Radiology, University Hospital Nürnberg, Nürnberg, Germany

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)

July 1, 2024

Primary Completion (Actual)

November 30, 2024

Study Completion (Actual)

March 31, 2025

Study Registration Dates

First Submitted

October 11, 2024

First Submitted That Met QC Criteria

October 11, 2024

First Posted (Actual)

October 15, 2024

Study Record Updates

Last Update Posted (Actual)

January 30, 2026

Last Update Submitted That Met QC Criteria

January 29, 2026

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WBEMS_Back_Outpatient

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

product manufactured in and exported from the U.S.

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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