- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07411053
The Effects of EMS-Combined Body Awareness Exercises on Non-Specific Low Back Pain
Low back pain is one of the most prevalent musculoskeletal conditions worldwide and is a leading cause of disability and reduced quality of life. Non-specific low back pain (NSLBP), which has no identifiable underlying pathology, accounts for the majority of low back pain cases and often requires a multidisciplinary rehabilitation approach.
Body awareness-based exercises aim to improve postural control, movement quality, and the individual's perception of bodily sensations, and have been shown to be beneficial in chronic pain management. Electrical muscle stimulation (EMS) is a non-invasive modality that enhances neuromuscular activation and may support functional recovery when combined with exercise interventions.
The purpose of this study is to investigate the effects of EMS-combined body awareness exercises on pain intensity, functional disability, and body awareness in individuals with non-specific low back pain. Participants will be randomly assigned to either an intervention group receiving EMS-assisted body awareness training or a control group receiving standard body awareness exercises. Outcome measures will be assessed before and after the intervention period.
This study aims to provide evidence on whether the addition of EMS to body awareness-based rehabilitation leads to superior clinical outcomes compared to body awareness exercises alone in individuals with non-specific low back pain.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study is designed as a randomized controlled trial investigating the effectiveness of combining electrical muscle stimulation (EMS) with body awareness-based exercises in individuals with non-specific low back pain. The study will be conducted in an outpatient physiotherapy setting and will include adult participants diagnosed with non-specific low back pain according to clinical criteria.
Participants will be randomly allocated into two groups: an experimental group receiving EMS-assisted body awareness exercises and a control group receiving body awareness exercises alone. Both groups will participate in a structured rehabilitation program focusing on posture, movement quality, breathing, and proprioceptive awareness. The intervention will be delivered by trained physiotherapists under standardized conditions.
Electrical muscle stimulation will be applied to the lumbar and related trunk muscles during selected exercise components in the experimental group, with stimulation parameters adjusted according to participant tolerance and safety guidelines. The control group will perform the same exercise protocol without EMS application.
Primary outcomes will include pain intensity and functional disability, assessed using validated self-report questionnaires. Secondary outcomes will include body awareness levels and movement-related functional measures. Assessments will be conducted at baseline and after completion of the intervention period.
This study aims to determine whether the integration of EMS into a body awareness-based rehabilitation program provides additional benefits in pain reduction, functional improvement, and body awareness compared to body awareness exercises alone in individuals with non-specific low back pain.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Aged between 18 and 65 years
- Diagnosed with non-specific low back pain for at least 3 months
- Pain intensity of ≥4 on the Numeric Rating Scale (NRS)
- Ability to understand and follow exercise instructions
- Willingness to participate in the study and provide written informed consent
Exclusion Criteria:
- Specific causes of low back pain (e.g., disc herniation with neurological deficit, spinal stenosis, spondylolisthesis, fracture, infection, tumor)
- History of spinal surgery within the last 12 months
- Known neurological disorders affecting movement or sensation
- Diagnosed rheumatological or inflammatory diseases (e.g., ankylosing spondylitis, rheumatoid arthritis)
- Pregnancy
- Presence of cardiac pacemaker or implanted electronic devices (contraindication for EMS)
- Severe osteoporosis or other conditions contraindicating exercise
- Current participation in another structured physiotherapy or rehabilitation program
- Cognitive impairment or psychiatric conditions limiting cooperation with the protocol
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: EMS-Assisted Body Awareness Exercise Group
Participants in this group will receive a structured body awareness-based exercise program combined with electrical muscle stimulation (EMS).
EMS will be applied to the lumbar and related trunk muscles during selected exercise components in order to enhance neuromuscular activation and sensorimotor integration.
The intervention will be delivered by trained physiotherapists under standardized clinical conditions.
|
This intervention consists of a body awareness-based rehabilitation program supported by electrical muscle stimulation.
EMS will be applied to the lumbar and trunk muscles during selected exercises to facilitate muscle activation, improve postural control, and enhance sensorimotor awareness.
The exercise program will include postural alignment, breathing regulation, controlled movement patterns, and proprioceptive training.
This intervention consists of a structured body awareness-based exercise program focusing on postural control, breathing, movement quality, and proprioceptive awareness.
Exercises will be performed without any electrical stimulation and will be supervised by trained physiotherapists
|
|
Active Comparator: Exercise Group
Participants in this group will receive the same structured body awareness-based exercise program without electrical muscle stimulation.
The program will focus on posture, breathing, movement quality, and proprioceptive awareness, and will be delivered by trained physiotherapists under standardized clinical conditions.
|
This intervention consists of a structured body awareness-based exercise program focusing on postural control, breathing, movement quality, and proprioceptive awareness.
Exercises will be performed without any electrical stimulation and will be supervised by trained physiotherapists
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Functional Disability
Time Frame: Baseline (Week 0) and Week 8
|
Functional disability will be evaluated using the Oswestry Disability Index (ODI), which assesses the impact of low back pain on daily activities such as walking, sitting, standing, and lifting.
Higher scores indicate greater levels of disability.
|
Baseline (Week 0) and Week 8
|
|
Pain intensity
Time Frame: Baseline (Week 0) and Week 8
|
Pain intensity will be assessed using the Numeric Rating Scale (NRS), where participants rate their current low back pain intensity on an 11-point scale ranging from 0 (no pain) to 10 (worst imaginable pain). The NRS is a valid and reliable tool for measuring pain in individuals with musculoskeletal conditions. Time Frame: Baseline and post-intervention (after completion of the intervention period) |
Baseline (Week 0) and Week 8
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2026/01-1795
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Low Back Pain
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University of Kansas Medical CenterCompletedLower Back Pain | Low Back Pain | Low Back Pain, Mechanical | Low Back Pain, Recurrent | Low Back Pain, Postural | Postural Low Back Pain | Mechanical Low Back Pain | Low Back Ache | Recurrent Low Back Pain | Lower Back Pain Chronic | Low Back Pain, Posterior Compartment | Low BackacheUnited States
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Istanbul UniversityIstinye UniversityCompletedLow Back Pain | Low Back Pain, Mechanical | Low Back Pain, Recurrent | Low Back Pain, PosturalTurkey
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Dow University of Health SciencesRecruitingLow Back Pain | Chronic Low-back Pain | Low Back Pain, Mechanical | Mechanical Low Back Pain | Pain, Chronic | Pain, Back | Lower Back Pain Chronic | CLBP - Chronic Low Back PainPakistan
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Faculdade de Ciências Médicas da Santa Casa de...CompletedLow Back Pain, Mechanical | Low Back Pain, Postural | Lower Back Pain Chronic | Low Back Pain, Posterior CompartmentBrazil
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General Incorporated Foundation Ryukyuseimeisaiseikai...CompletedChronic Low Back Pain | Non-specific Low Back Pain | Low Back Pain (LBP)Japan
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University School of Physical Education in WroclawCompletedLow Back Pain | Low Back Pain, Mechanical | Low Back Pain, PosturalPoland
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Texas Woman's UniversityTexas Physical Therapy AssociationCompletedLow Back Pain | Chronic Low Back Pain | Subacute Low Back PainUnited States
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University of ParmaKing's College London; Helmholtz Zentrum München; GENOS; Ip Research Consulting... and other collaboratorsUnknownChronic Low Back Pain | Acute Low Back PainUnited States, Australia, Belgium, Croatia, Italy, United Kingdom
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Karolinska InstitutetCompletedChronic Low Back Pain | Recurrent Low Back Pain | Persistent Low Back PainSweden
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Ache Laboratorios Farmaceuticos S.A.Unknown
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