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

NCT06642350 | Completed

• 1 other identifier: WBEMS_Back_Outpatient
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Low Back Pain

Keywords

Exercise; Whole-body electromyostimulation; non-specific chronic low-back pain; medical training therapy; outpatient clinic

Outcome Measures

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

  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 Outcomes (5)

• Changes of disability from baseline to 10 week follow-up assessment as determine by the Roland Morris Disability Questionnaire (RMDQ)

  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

  "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

  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)

  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

  From enrollment (baseline assessment) to the end of treatment at 10 weeks

Study Arms (2)

Whole-body electromyostimulation

EXPERIMENTAL

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

Other: Whole-body electrostimulation

Medical training therapy (MTT)

ACTIVE COMPARATOR

MTT 2x 45 min/week for 10 weeks

Other: Medical Training Therapy

Interventions

Whole-body electrostimulation OTHER

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

Also known as: WB-EMS

Whole-body electromyostimulation

Medical Training Therapy OTHER

10 weeks of MTT 2x 45 min/week

Also known as: MTT

Medical training therapy (MTT)

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead
• Rehamed Center Forchheim, Germany: collaborator

Study Sites (1)

Institute of Radiology, University Hospital Nürnberg

Erlangen, 91052, Germany

Location

Related Publications (1)

• 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.

  PMID: 33927646 BACKGROUND

MeSH Terms

Conditions

Low Back Pain; Motor Activity

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Wolfgang Kemmler, PhD

  Institute of Radiology, University Hospital Nürnberg, Nürnberg, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors are unaware of participant status (WB-EMS or MTT) and were not allowed to ask participants correspondingly
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2024
• First Posted: October 15, 2024
• Study Start: July 1, 2024
• Primary Completion: November 30, 2024
• Study Completion: March 31, 2025
• Last Updated: January 30, 2026

Record last verified: 2024-10

Locations

DE (1)