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

NCT07411053 | Not Yet Recruiting

• 1 other identifier: 2026/01-1795
• Study Type: interventional
• Target: 72
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Low Back Pain

Keywords

Low Back Pain; Electrical Muscle Stimulation; Body Awareness

Outcome Measures

Primary Outcomes (2)

• Functional Disability

  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

  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

Study Arms (2)

EMS-Assisted Body Awareness Exercise Group

EXPERIMENTAL

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.

Behavioral: EMS-Assisted Body Awareness Exercises; Behavioral: Exercises

Exercise Group

ACTIVE COMPARATOR

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.

Behavioral: Exercises

Interventions

EMS-Assisted Body Awareness Exercises BEHAVIORAL

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.

EMS-Assisted Body Awareness Exercise Group

Exercises BEHAVIORAL

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

EMS-Assisted Body Awareness Exercise Group; Exercise Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Recep Tayyip Erdogan University: lead
• İstanbul Yeni Yüzyıl Üniversitesi: collaborator

MeSH Terms

Conditions

Low Back Pain

Interventions

Exercise

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Model Details: This study follows a parallel-group randomized controlled design, in which participants are allocated to either an EMS-assisted body awareness exercise group or a body awareness exercise-only control group. Both groups receive the same structured rehabilitation protocol, with the experimental group additionally receiving synchronized electrical muscle stimulation during selected exercise components. Outcomes are assessed pre- and post-intervention to compare between-group and within-group effects.

Study Record Dates

• First Submitted: January 31, 2026
• First Posted: February 13, 2026
• Study Start: February 1, 2026
• Primary Completion: May 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share