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Not yet recruiting NCT07411053

The Effects of EMS-Combined Body Awareness Exercises on Non-Specific Low Back Pain

No phase Interventional Low Back Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: EMS-Assisted Body Awareness Exercises, Exercises.
Who it may be relevant to
Registry conditions: Low Back Pain. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

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.

Interventions

  • Behavioral EMS-Assisted Body Awareness Exercises
    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.
  • Behavioral Exercises
    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

Primary outcome measures

  • Functional Disability [Time frame: Baseline (Week 0) and Week 8]
  • Pain intensity [Time frame: Baseline (Week 0) and Week 8]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07411053 · 2026/01-1795

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗