Low Back PainNCT07857642
Effects of Mental Participation During Lumbar Stabilization and Neuromuscular Electrical Stimulation in Chronic Non-Specific Low Back Pain
A study testing Exercise + NMES and Exercise in people with Low Back Pain and Low Back Pain, Mechanical, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
This study was conducted to investigate the effects of incorporating synchronized voluntary muscle activation and active motor engagement during neuromuscular electrical stimulation (NMES) into a lumbar stabilization exercise program in individuals with chronic non-specific low back pain. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain, Low Back Pain, Mechanical, NMES
- What is being tested?
- Exercise + NMES and Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2022to 1 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18 and 60 years of age
- Experienced CNSLBP for longer than three months without a specific identifiable anatomical cause
Who cannot join
- Serious spinal pathology such as malignancy or infection
- Neurological or cardiovascular disorders
- A History of spinal surgery,
- Epilepsy
- Pregnancy
- Metallic implants
- Recent use of neuromuscular or functional electrical stimulation
- Body mass index greater than 30 kg/m².
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Aydin University
Istanbul, Istanbul, 34180
About this study
This study was conducted to investigate the effects of incorporating synchronized voluntary muscle activation and active motor engagement during neuromuscular electrical stimulation (NMES) into a lumbar stabilization exercise program in individuals with chronic non-specific low back pain. Thirty-six individuals with chronic non-specific low back pain were randomly assigned to two groups. Both groups participated in an 8-week lumbar stabilization exercise program combined with NMES, administered twice weekly. The experimental group performed synchronized voluntary muscle activation and active motor engagement during NMES, whereas the control group received NMES without voluntary muscle activation. Pain intensity, disability, trunk endurance, lumbopelvic motor control, stabilization parameters, depression, fear-avoidance beliefs, and trunk range of motion were assessed to evaluate the effects of the intervention.
- Conditions
- Low Back Pain, Low Back Pain, Mechanical, NMES, Mental Perception, Exercise
- Being tested
- Exercise + NMES, Exercise
- Keywords
- low back pain, NMES, motor control
- Medical subject headings
- Low Back Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise + NMESOther
Also called EXERCİSE, NMES
NMES was applied bilaterally to the abdominal and paraspinal muscles using a COMPEX 3.0 device for 20 minutes. A biphasic rectangular waveform with a pulse duration of 400 μs was used. The protocol included a 2-minute warm-up at 6 Hz, a 75-Hz contraction phase, a 3-minute active rest phase at 4 Hz, and a recovery phase at 3 Hz. Stimulation intensity was individually adjusted according to tolerance, up to 120 mA. The contraction-to-rest cycle was 5 seconds of stimulation and 10 seconds of rest, with 1.5-second ramp-up and 0.5-second ramp-down times.
In the experimental group, participants voluntarily contracted the stimulated muscles synchronously with NMES-induced contractions, with emphasis on abdominal bracing and trunk stabilization. Standardized verbal instructions and therapist-guided tactile feedback were provided. The control group received the same NMES protocol without voluntary muscle contraction or active motor engagement.
ExerciseOther
The program was designed to improve trunk stabilization and lumbopelvic motor control and included supine abdominal bracing exercises (heel slide, unilateral leg lift, and bridging) and quadruped exercises (arm lift, leg lift, and contralateral arm-leg lift).
| Study group | Role | What they receive |
|---|---|---|
| Exercise + NMES with mental perceptions | Experimental | NMES was applied bilaterally to the abdominal and paraspinal muscles using a COMPEX 3.0 device for 20 minutes. A biphasic rectangular waveform with a pulse duration of 400 μs was used. The protocol included a 2-minute warm-up at 6 Hz, a 75-Hz contraction phase, a 3-minute active rest phase at 4 Hz, and a recovery phase at 3 Hz. Stimulation intensity was individually adjusted according to tolerance, up to 120 mA. The contraction-to-rest cycle was 5 seconds of stimulation and 10 seconds of rest, with 1.5-second ramp-up and 0.5-second ramp-down times.
In the experimental group, participants voluntarily contracted the stimulated muscles synchronously with NMES-induced contractions, with emphasis on abdominal bracing and trunk stabilization. Standardized verbal instructions and therapist-guided tactile feedback were provided. The control group received the same NMES protocol without voluntary muscle contraction or active motor engagement. Receives: Other: Exercise + NMES |
| Exercise | Active comparator | The program was designed to improve trunk stabilization and lumbopelvic motor control and included supine abdominal bracing exercises (heel slide, unilateral leg lift, and bridging) and quadruped exercises (arm lift, leg lift, and contralateral arm-leg lift). Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS)
Pain intensity will be assessed using the Visual Analog Scale (VAS), a widely used and validated measure of subjective pain severity in individuals with musculoskeletal disorders. Participants will indicate their perceived pain intensity on the scale, with higher scores indicating greater pain severity.
Measured: Baseline and post-intervention (8 weeks)
Secondary outcomes (6)
Oswestry Disability Index (ODI)
Low back pain-related disability will be assessed using the Oswestry Disability Index (ODI), a widely used outcome measure evaluating the impact of low back pain on functional activities. Higher scores indicate greater disability.
Measured: Baseline and post-intervention (8 weeks)
Prone Plank Test
Trunk muscle endurance will be assessed using the prone plank test. The test will evaluate the participant's ability to maintain a standardized plank position, with longer holding times indicating greater trunk muscle endurance.
Measured: Baseline and post-intervention (8 weeks)
Lumbopelvic Motor Control and Stabilization
Lumbopelvic motor control and stabilization will be assessed using the Chattanooga Stabilizer Pressure Biofeedback device. The device will be used to monitor changes in pressure during standardized stabilization tasks, providing an assessment of the participant's ability to control and maintain lumbopelvic stability.
Measured: Baseline and post-intervention (8 weeks)
Trunk Range of Motion
Trunk range of motion will be assessed using a standard goniometer. The range of movement will be recorded for the relevant trunk movements, with greater values indicating a greater available range of motion.
Measured: Baseline and post-intervention (8 weeks)
Beck Depression Inventory (BDI)
Depressive symptoms will be evaluated using the Beck Depression Inventory (BDI), a self-report questionnaire designed to assess the severity of depressive symptoms. Higher scores indicate greater severity of depressive symptoms.
Measured: Baseline and post-intervention (8 weeks)
Fear-Avoidance Beliefs Questionnaire (FABQ)
Fear-avoidance beliefs will be assessed using the Fear-Avoidance Beliefs Questionnaire (FABQ). The questionnaire evaluates fear and avoidance beliefs related to physical activity and work in individuals with musculoskeletal pain, with higher scores indicating stronger fear-avoidance beliefs.
Measured: Baseline and post-intervention (8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study start1 Feb 2022
- Primary completion1 May 2022
- Study completion1 Jul 2022
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.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Büşra Aksan Sadıkoğlu, Istanbul Kent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07857642
- Sponsor's protocol ID
- IAU2022
- Status last verified
- Oct 2026
- First submitted
- 28 Sep 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Mental Participation During Lumbar Stabilization and Neuromuscular Electrical Stimulation in Chronic Non-Specific Low Back Pain
- ClinicalTrials.gov ID
- NCT07857642
- Acronym / sponsor ID
- IAU2022
- Conditions
- Low Back Pain, Low Back Pain, Mechanical, NMES, Mental Perception, Exercise
- Keywords
- low back pain, NMES, motor control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 5 Oct 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.
This study was conducted to investigate the effects of incorporating synchronized voluntary muscle activation and active motor engagement during neuromuscular electrical stimulation (NMES) into a lumbar stabilization exercise program in individuals with chronic non-specific low back pain. Thirty-six individuals with chronic non-specific low back pain were randomly assigned to two groups. Both groups participated in an 8-week lumbar stabilization exercise program combined with NMES, administered twice weekly. The experimental group performed synchronized voluntary muscle activation and active motor engagement during NMES, whereas the control group received NMES without voluntary muscle activation. Pain intensity, disability, trunk endurance, lumbopelvic motor control, stabilization parameters, depression, fear-avoidance beliefs, and trunk range of motion were assessed to evaluate the effects of the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise + NMES with mental perceptions | Experimental | Other: Exercise + NMESNMES was applied bilaterally to the abdominal and paraspinal muscles using a COMPEX 3.0 device for 20 minutes. A biphasic rectangular waveform with a pulse duration of 400 μs was used. The protocol included a 2-minute warm-up at 6 Hz, a 75-Hz contraction phase, a 3-minute active rest phase at 4 Hz, and a recovery phase at 3 Hz. Stimulation intensity was individually adjusted according to tolerance, up to 120 mA. The contraction-to-rest cycle was 5 seconds of stimulation and 10 seconds of rest, with 1.5-second ramp-up and 0.5-second ramp-down times. In the experimental group, participants voluntarily contracted the stimulated muscles synchronously with NMES-induced contractions, with emphasis on abdominal bracing and trunk stabilization. Standardized verbal instructions and therapist-guided tactile feedback were provided. The control group received the same NMES protocol without voluntary muscle contraction or active motor engagement. |
| Exercise | Active comparator | Other: ExerciseThe program was designed to improve trunk stabilization and lumbopelvic motor control and included supine abdominal bracing exercises (heel slide, unilateral leg lift, and bridging) and quadruped exercises (arm lift, leg lift, and contralateral arm-leg lift). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 18 and 60 years of age
- Experienced CNSLBP for longer than three months without a specific identifiable anatomical cause
Key exclusion criteria (8 listed)
- Serious spinal pathology such as malignancy or infection
- Neurological or cardiovascular disorders
- A History of spinal surgery,
- Epilepsy
- 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 |
|---|---|---|
| Exercise + NMESAlso: EXERCİSE, NMESNMES was applied bilaterally to the abdominal and paraspinal muscles using a COMPEX 3.0 device for 20 minutes. A biphasic rectangular waveform with a pulse duration of 400 μs was used. The protocol included a 2-minute warm-up at 6 Hz, a 75-Hz contraction phase, a 3-minute active rest phase at 4 Hz, and a recovery phase at 3 Hz. Stimulation intensity was individually adjusted according to tolerance, up to 120 mA. The contraction-to-rest cycle was 5 seconds of stimulation and 10 seconds of rest, with 1.5-second ramp-up and 0.5-second ramp-down times. In the experimental group, participants voluntarily contracted the stimulated muscles synchronously with NMES-induced contractions, with emphasis on abdominal bracing and trunk stabilization. Standardized verbal instructions and therapist-guided tactile feedback were provided. The control group received the same NMES protocol without voluntary muscle contraction or active motor engagement. | Other | Exercise + NMES with mental perceptions |
| ExerciseThe program was designed to improve trunk stabilization and lumbopelvic motor control and included supine abdominal bracing exercises (heel slide, unilateral leg lift, and bridging) and quadruped exercises (arm lift, leg lift, and contralateral arm-leg lift). | Other | Exercise |
Primary outcome
Visual Analog Scale (VAS)
Time frame: Baseline and post-intervention (8 weeks)
Pain intensity will be assessed using the Visual Analog Scale (VAS), a widely used and validated measure of subjective pain severity in individuals with musculoskeletal disorders. Participants will indicate their perceived pain intensity on the scale, with higher scores indicating greater pain severity.
6 secondary outcomes
Oswestry Disability Index (ODI)
Time frame: Baseline and post-intervention (8 weeks)
Prone Plank Test
Time frame: Baseline and post-intervention (8 weeks)
Lumbopelvic Motor Control and Stabilization
Time frame: Baseline and post-intervention (8 weeks)
Trunk Range of Motion
Time frame: Baseline and post-intervention (8 weeks)
Beck Depression Inventory (BDI)
Time frame: Baseline and post-intervention (8 weeks)
Fear-Avoidance Beliefs Questionnaire (FABQ)
Time frame: Baseline and post-intervention (8 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise + NMES and Exercise in people with Low Back Pain and Low Back Pain, Mechanical, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
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 2 inclusion and 8 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: finished, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Visual Analog Scale (VAS) (time frame: Baseline and post-intervention (8 weeks)). 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 5 Oct 2026.