Low Back PainNCT07411053
The Effects of EMS-Combined Body Awareness Exercises on Non-Specific Low Back Pain
A study testing EMS-Assisted Body Awareness Exercises and Exercises in people with Low Back Pain, run by Recep Tayyip Erdogan University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- EMS-Assisted Body Awareness Exercises and Exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2026to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Low Back Pain
- Being tested
- EMS-Assisted Body Awareness Exercises, Exercises
- Keywords
- Low Back Pain, Electrical Muscle Stimulation, Body Awareness
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMS-Assisted Body Awareness ExercisesBehavioural
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.
ExercisesBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: Baseline (Week 0) and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start1 Feb 2026 (estimated)
- Primary completion1 May 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- 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
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Recep Tayyip Erdogan University
- Sponsor type
- University, hospital or other
- Collaborators
- İstanbul Yeni Yüzyıl Üniversitesi
- Responsible party
- Principal investigator, Seda Karaca, Recep Tayyip Erdogan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07411053
- Sponsor's protocol ID
- 2026/01-1795
- Status last verified
- Feb 2026
- First submitted
- 31 Jan 2026
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared publicly in order to protect participant privacy and confidentiality. The dataset contains sensitive health-related information, and data sharing is restricted in accordance with ethical approval and data protection regulations.
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of EMS-Combined Body Awareness Exercises on Non-Specific Low Back Pain
- ClinicalTrials.gov ID
- NCT07411053
- Acronym / sponsor ID
- 2026/01-1795
- Conditions
- Low Back Pain
- Keywords
- Low Back Pain, Electrical Muscle Stimulation, Body Awareness
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Recep Tayyip Erdogan UniversityUniversity, hospital or other
- Collaborators
- İstanbul Yeni Yüzyıl Üniversitesi
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 13 Feb 2026 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| EMS-Assisted Body Awareness Exercise Group | Experimental | Behavioral: EMS-Assisted Body Awareness Exercises, Behavioral: ExercisesParticipants 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: ExercisesParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
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 |
|---|---|---|
| EMS-Assisted Body Awareness ExercisesThis 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. | Behavioural | EMS-Assisted Body Awareness Exercise Group |
| ExercisesThis 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 | Behavioural | EMS-Assisted Body Awareness Exercise Group, Exercise Group |
Primary outcome
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.
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared publicly in order to protect participant privacy and confidentiality. The dataset contains sensitive health-related information, and data sharing is restricted in accordance with ethical approval and data protection regulations.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing EMS-Assisted Body Awareness Exercises and Exercises in people with Low Back Pain, run by Recep Tayyip Erdogan University.
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 5 inclusion and 9 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: opening soon, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Functional Disability (time frame: Baseline (Week 0) and Week 8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Feb 2026.