Clinical trial NCT06642350: Whole-Body Electromyostimulation Versus Therapeutic Resistance Exercise for the Treatment of Non-Specific Chronic Low Back Pain
Official 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.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Low Back Pain
Keywords: Exercise
Whole-body electromyostimulation
non-specific chronic low-back pain
medical training therapy
outpatient clinic
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
Collaborators: name: Rehamed Center Forchheim, Germany
First posted: 2024-10-15
Enrollment: 26
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Changes of non-specific low back pain from baseline to 10 week follow-up assessment as determined by the numeric rating scale 0-10
timeFrame: From enrollment (baseline assessment) to the end of treatment at 10 weeks"
Secondary outcomes:
measure: Changes of disability from baseline to 10 week follow-up assessment as determine by the Roland Morris Disability Questionnaire (RMDQ)
timeFrame: From enrollment (baseline) to the end of treatment at 10 weeks"
measure: Changes of back extension strength from baseline to 10 week follow-up assessment as determined by the Dr. Wolf back-check device
timeFrame: "From enrollment (baseline assessment) to the end of treatment at 10 weeks"
measure: Changes of trunk flexion strength from baseline to 10 week follow-up assessment as determined by the Dr. Wolf back-check device
timeFrame: From enrollment (baseline assessment) to the end of treatment at 10 weeks"
measure: Changes of lean body mass from baseline to 10 week assessment as determined by bio impedance assessment (BIA)
timeFrame: From enrollment (baseline assessment) to the end of treatment at 10 weeks
measure: Changes of body fat from baseline to 10 week follow-up assessment as determine by bio impedance analysis
timeFrame: From enrollment (baseline assessment) to the end of treatment at 10 weeks
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: Institute of Radiology, University Hospital Nürnberg
Study officials:
affiliation: Institute of Radiology, University Hospital Nürnberg, Nürnberg, Germany
name: Wolfgang Kemmler, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.