Low Back PainBackDFGETNCT06642350
Whole-Body Electromyostimulation Versus Therapeutic Resistance Exercise for the Treatment of Non-Specific Chronic Low Back Pain
A study testing Whole-body electrostimulation and Medical Training Therapy in people with Low Back Pain, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Whole-body electrostimulation and Medical Training Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jul 2024to 31 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Germany1 site
Institute of Radiology, University Hospital Nürnberg
Erlangen, 91052
About this study
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.
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
- Being tested
- Whole-body electrostimulation, Medical Training Therapy
- Keywords
- Exercise, Whole-body electromyostimulation, non-specific chronic low-back pain, medical training therapy, outpatient clinic
- Medical subject headings
- Low Back Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole-body electrostimulationOther
Also called WB-EMS
10 weeks of WB-EMS 1.5x 20 min/week
Medical Training TherapyOther
Also called MTT
10 weeks of MTT 2x 45 min/week
| Study group | Role | What they receive |
|---|---|---|
| Whole-body electromyostimulation | Experimental | WB-EMS 1.5x 20 min/week for 10 weeks Receives: Other: Whole-body electrostimulation |
| Medical training therapy (MTT) | Active comparator | MTT 2x 45 min/week for 10 weeks Receives: Other: Medical Training Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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."
Measured: 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)
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.
Measured: 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
Dr. Wolf back-check: Isometric test device for trunk strength
Measured: "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
Dr. Wolf Back check: Isometric test device for trunk strength
Measured: 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)
BIA: Assessment of lean body mass by direct-segmental multi-frequency bioimpedance analysis using InBody 770 (Seoul, Korea)
Measured: 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
BIA: Assessment of lean body mass by direct-segmental multi-frequency bio impedance analysis using InBody 770 (Seoul, Korea)
Measured: From enrollment (baseline assessment) to the end of treatment at 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start1 Jul 2024
- Primary completion30 Nov 2024
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by University of Erlangen-Nürnberg Medical SchoolThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- Rehamed Center Forchheim, Germany
- Responsible party
- Sponsor
- Investigators
- Wolfgang Kemmler, PhD, Principal investigator, Institute of Radiology, University Hospital Nürnberg, Nürnberg, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06642350
- Sponsor's protocol ID
- WBEMS_Back_Outpatient
- Acronym
- BackDFGET
- Status last verified
- Oct 2024
- First submitted
- 11 Oct 2024
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 33927646
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06642350
- Acronym / sponsor ID
- BackDFGET / WBEMS_Back_Outpatient
- Conditions
- Low Back Pain
- Keywords
- Exercise, Whole-body electromyostimulation, non-specific chronic low-back pain, medical training therapy, outpatient clinic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Collaborators
- Rehamed Center Forchheim, Germany
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Whole-body electromyostimulation | Experimental | Other: Whole-body electrostimulationWB-EMS 1.5x 20 min/week for 10 weeks |
| Medical training therapy (MTT) | Active comparator | Other: Medical Training TherapyMTT 2x 45 min/week for 10 weeks |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole-body electrostimulationAlso: WB-EMS10 weeks of WB-EMS 1.5x 20 min/week | Other | Whole-body electromyostimulation |
| Medical Training TherapyAlso: MTT10 weeks of MTT 2x 45 min/week | Other | Medical training therapy (MTT) |
Primary outcome
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."
5 secondary outcomes
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"
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"
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"
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
- Background: PubMed 33927646Micke 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wolfgang Kemmler, PhD principal investigator
Institute of Radiology, University Hospital Nürnberg, Nürnberg, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole-body electrostimulation and Medical Training Therapy in people with Low Back Pain, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: From enrollment (baseline assessment) to the end of treatment at 10 weeks"). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06642350, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026.