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Completed

NCT Number: NCT06642350

Whole-Body Electromyostimulation Versus Therapeutic Resistance Exercise for the Treatment of Non-Specific Chronic 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.

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Key information

Conditions

Low Back Pain Back Pain Behavior Motor Activity Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Radiology, University Hospital Nürnberg

Erlangen, 91052, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Whole-body electrostimulation

Other

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

Other names: WB-EMS

Medical Training Therapy

Other

10 weeks of MTT 2x 45 min/week

Other names: MTT

Primary outcomes

  1. 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."

Secondary outcomes

  1. 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.

  2. 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

  3. 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

  4. 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)

  5. 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)

Sponsors and collaborators

Lead sponsor

University of Erlangen-Nürnberg Medical School

Other

Collaborators

  • Rehamed Center Forchheim, Germany

Registry information

Official study title

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.

Acronym: BackDFGET

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Oct 15, 2024
Registry last updated
Jan 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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