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

Not Applicable

Active, not recruiting

• Conditions: Low Back Pain

• Registration Number: NCT06642350
• Lead Sponsor: University of Erlangen-Nürnberg Medical School

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-01
• Status Verified: 2024-10
• Study First Submitted: 2024-10-11
• Study First Submitted QC: 2024-10-11
• Study First Posted: 2024-10-15
• Primary Completion: 2024-11-30
• Last Update Submitted: 2025-02-03
• Last Update Posted: 2025-02-06
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 26

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Changes of non-specific low back pain from baseline to 10 week follow-up assessment as determined by the numeric rating scale 0-10	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 Outcome Measures

Name	Time	Method
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"	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.
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"	Dr. Wolf Back check: Isometric test device for trunk strength
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	BIA: Assessment of lean body mass by direct-segmental multi-frequency bioimpedance analysis using InBody 770 (Seoul, Korea)
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"	Dr. Wolf back-check: Isometric test device for trunk strength
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	BIA: Assessment of lean body mass by direct-segmental multi-frequency bio impedance analysis using InBody 770 (Seoul, Korea)

Trial Locations

Locations (1)

Institute of Radiology, University Hospital Nürnberg; 🇩🇪 Erlangen, Germany