| Registry | NCT07411053 |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: quadruple, treatment |
| Enrollment | 72 (Estimated) |
| Sponsor | Recep Tayyip Erdogan University (Other); collaborators: İstanbul Yeni Yüzyıl Üniversitesi |
| Conditions | Low Back Pain |
| Interventions | EMS-Assisted Body Awareness Exercises, Exercises (Behavioral) |
| Dates | start 2026-02-01 (estimated), primary completion 2026-05-01 (estimated), completion 2026-06-01 (estimated), first posted 2026-02-13, last updated 2026-02-13 |
Related Papers Related Patents Related Grants Related Experts
All trials for Low Back Pain All trials of EMS-Assisted Body Awareness Exercises All trials of Exercises
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| EMS-Assisted Body Awareness Exercise Group | Experimental | Behavioral: EMS-Assisted Body Awareness Exercises; Behavioral: Exercises | 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. |
| Exercise Group | Active comparator | Behavioral: Exercises | 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. |
Sex: All, ages: 18 Years to 65 Years
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