Low Back PainNCT06212011
Effect of Neuromuscular Electrical Stimulation Applied to the Lumbar Multifidus Muscle on Sit to Stand Kinematics in Individuals With Low Back Pain
A study testing Functional Neuromuscular Electrical Stimulation and Conventional Neuromuscular Electrical Stimulation in people with Low Back Pain, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this randomized controlled trial, is to investigate the effect of functional NMES and conventional NMES applied to the lumbar multifidus muscle on body kinematic and kinetic values during the sit-to-stand in individuals with non-specific low back pain. 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?
- Functional Neuromuscular Electrical Stimulation and Conventional Neuromuscular Electrical Stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2024to 15 Jun 2025
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of chronic low back pain (12 weeks<)
- Pain in the lumbar and/or hip area (VAS>3)
- Volunteering to participate in the study
Who cannot join
- History of neurological, metabolic, cardiovascular disease
- Having had spinal surgery, specific lumbar pathology, scoliosis, pregnancy, history of systemic or degenerative disease
- Musculoskeletal system pathology in the last year
- Body mass index being over 30 kg/m2
- Continuing any exercise program
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation on the Effect of Functional Neuromuscular Electrical Stimulation Technique Applied to the Lumbar Multifidus Muscle On Body Kinetics and Kinematics During Sit to Stand Activity In Individuals With Nonspecific Low Back Pain
The goal of this randomized controlled trial, is to investigate the effect of functional NMES and conventional NMES applied to the lumbar multifidus muscle on body kinematic and kinetic values during the sit-to-stand in individuals with non-specific low back pain. Our study will include 24 participants between the ages of 18-65. Which physiotherapy intervention will be applied to the participants will be determined by the block randomization method, using a table of random numbers. After randomization; NMES to the participants' lumbar multifidus muscle during physiotherapy intervention will be applied in two groups; In the first group, NMES will be applied with the conventional technique during prone position and in the second group, NMES will be applied with the functional technique during the sit-to-stand activity. Evaluations will be made twice for each participant- before and after the intervention. During the evaluation, data regarding the change in body kinetics and kinematics of individuals during the sit-to-stand activity will be recorded with a Vicon camera system. For secondary outcome measures, a visual analog scale will be used to evaluate pain, the Roland Morris Disability Questionnaire and the Oswestry Disability Index will be used to evaluate functional status, and the Tampa Kinesiophobia Scale will be used to evaluate fear-avoidance behavior.
- Conditions
- Low Back Pain
- Being tested
- Functional Neuromuscular Electrical Stimulation, Conventional Neuromuscular Electrical Stimulation
- Keywords
- low back pain, electric stimulation, sit to stand, kinetic, kinematic
- 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.
Functional Neuromuscular Electrical StimulationOther
The functional NMES technique involves the application of electrical stimulation during functional activity. In our study, in the functional neuromuscular electrical simulation group, neuromuscular electrical stimulation will be applied to the lumbar multifidus muscle while individuals perform the activity of standing up from sitting.
Conventional Neuromuscular Electrical StimulationOther
The conventional neuromuscular electrical simulation technique, electrical stimulation is applied without the individual performing voluntary contractions. In our study, conventional NMES will be applied to the lumbar multifidus muscle with the individual lying in the prone position and the individual will not elicit any voluntary contractions during the simulation.
| Study group | Role | What they receive |
|---|---|---|
| Functional Neuromuscular Electrical Stimulation Group | Experimental | Functional NMES involves stimulating the lumbar multifidus muscle while the individual performs a sit-to-stand activity. Receives: Other: Functional Neuromuscular Electrical Stimulation |
| Conventional Neuromuscular Electrical Stimulation Group | Experimental | Conventional NMES intervention involves only stimulating the lumbar multifidus muscle while the individual is in the prone position, and the individual will not reveal any voluntary contraction during stimulation. Receives: Other: Conventional Neuromuscular Electrical Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in kinematics of the Lumbar Spine and Hip During sit-to-stand activity
With kinematic analysis, the mean, minimum and maximum range of motion of the lumbar spine and hip joint during the sit-to-stand activity will be evaluated and recorded in degrees using the vicon motion capture system (Vicon, 6xVantage 5 Cameras 5MP@420FPS, 2xVue Video Cameras).
Measured: Baseline and first week after 8-week intervention
Changes in ground reaction force during sit-to-stand activity
Ground reaction force will be evaluated using force plates (2xAMTI force plates).
Measured: Baseline and first week after 8-week intervention
Secondary outcomes (7)
Hip and Lumbar spine range of motion
Hip and Lumbar spine range of motion will be evaluated using goniometer and recorded in degrees.
Measured: Baseline and first week after 8-week intervention
Shortness of the hip flexor, knee flexor and plantar flexor muscles
Shortness of the hip flexor, knee flexor and plantar flexor muscles will be evaluated by Thomas test, popliteal angle hamstring test and ankle dorsiflexion ROM measurements, respectively. Results will be recorded in degrees.
Measured: Baseline and first week after 8-week intervention
Beighton test
The Beighton test is a screening technique for hypermobility. The test is a nine-point scale and requires the performance of 5 maneuvers.
Measured: Baseline and first week after 8-week intervention
Visual analogue scale
Visual analog scale will be used to evaluate pain. The visual analog scale consists of a single 10 cm line used to evaluate pain intensity. Patients will be asked to mark the severity of their pain at rest, during activity and during night.
Measured: Baseline and first week after 8-week intervention
Oswestry Disability Index
Oswestry Disability Index will be used to evaluate the degree of loss of function. Higher values represent greater disability.
Measured: Baseline and first week after 8-week intervention
Roland-Morris Disability Questionnaire
Roland-Morris Disability Questionnaire will be used to evaluate functional disabilities. Higher values represent greater disability.
Measured: Baseline and first week after 8-week intervention
Tampa Kinesiophobia Scale
Tampa Kinesiophobia Scale will be used to evaluate fear of movement/reinjury. Higher values represent greater kinesiophobia.
Measured: Baseline and first week after 8-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study start1 May 2024
- Primary completion10 Jun 2025
- Study completion15 Jun 2025
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 Hacettepe UniversityThe 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
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Duygu Yilmaz, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06212011
- Sponsor's protocol ID
- 204574
- Status last verified
- Apr 2025
- First submitted
- 24 Dec 2023
- Last updated
- 2 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation on the Effect of Functional Neuromuscular Electrical Stimulation Technique Applied to the Lumbar Multifidus Muscle On Body Kinetics and Kinematics During Sit to Stand Activity In Individuals With Nonspecific Low Back Pain
- ClinicalTrials.gov ID
- NCT06212011
- Acronym / sponsor ID
- 204574
- Conditions
- Low Back Pain
- Keywords
- low back pain, electric stimulation, sit to stand, kinetic, kinematic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 10 Jun 2025 (actual)
- Study completion
- 15 Jun 2025 (actual)
- First posted
- 18 Jan 2024 (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.
The goal of this randomized controlled trial, is to investigate the effect of functional NMES and conventional NMES applied to the lumbar multifidus muscle on body kinematic and kinetic values during the sit-to-stand in individuals with non-specific low back pain. Our study will include 24 participants between the ages of 18-65. Which physiotherapy intervention will be applied to the participants will be determined by the block randomization method, using a table of random numbers. After randomization; NMES to the participants' lumbar multifidus muscle during physiotherapy intervention will be applied in two groups; In the first group, NMES will be applied with the conventional technique during prone position and in the second group, NMES will be applied with the functional technique during the sit-to-stand activity. Evaluations will be made twice for each participant- before and after the intervention. During the evaluation, data regarding the change in body kinetics and kinematics of individuals during the sit-to-stand activity will be recorded with a Vicon camera system. For secondary outcome measures, a visual analog scale will be used to evaluate pain, the Roland Morris Disability Questionnaire and the Oswestry Disability Index will be used to evaluate functional status, and the Tampa Kinesiophobia Scale will be used to evaluate fear-avoidance behavior.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Functional Neuromuscular Electrical Stimulation Group | Experimental | Other: Functional Neuromuscular Electrical StimulationFunctional NMES involves stimulating the lumbar multifidus muscle while the individual performs a sit-to-stand activity. |
| Conventional Neuromuscular Electrical Stimulation Group | Experimental | Other: Conventional Neuromuscular Electrical StimulationConventional NMES intervention involves only stimulating the lumbar multifidus muscle while the individual is in the prone position, and the individual will not reveal any voluntary contraction during stimulation. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- History of chronic low back pain (12 weeks<)
- Pain in the lumbar and/or hip area (VAS>3)
- Volunteering to participate in the study
Key exclusion criteria (5 listed)
- History of neurological, metabolic, cardiovascular disease
- Having had spinal surgery, specific lumbar pathology, scoliosis, pregnancy, history of systemic or degenerative disease
- Musculoskeletal system pathology in the last year
- Body mass index being over 30 kg/m2
- Continuing any exercise program
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 |
|---|---|---|
| Functional Neuromuscular Electrical StimulationThe functional NMES technique involves the application of electrical stimulation during functional activity. In our study, in the functional neuromuscular electrical simulation group, neuromuscular electrical stimulation will be applied to the lumbar multifidus muscle while individuals perform the activity of standing up from sitting. | Other | Functional Neuromuscular Electrical Stimulation Group |
| Conventional Neuromuscular Electrical StimulationThe conventional neuromuscular electrical simulation technique, electrical stimulation is applied without the individual performing voluntary contractions. In our study, conventional NMES will be applied to the lumbar multifidus muscle with the individual lying in the prone position and the individual will not elicit any voluntary contractions during the simulation. | Other | Conventional Neuromuscular Electrical Stimulation Group |
Primary outcome
Changes in kinematics of the Lumbar Spine and Hip During sit-to-stand activity
Time frame: Baseline and first week after 8-week intervention
With kinematic analysis, the mean, minimum and maximum range of motion of the lumbar spine and hip joint during the sit-to-stand activity will be evaluated and recorded in degrees using the vicon motion capture system (Vicon, 6xVantage 5 Cameras 5MP@420FPS, 2xVue Video Cameras).
Changes in ground reaction force during sit-to-stand activity
Time frame: Baseline and first week after 8-week intervention
Ground reaction force will be evaluated using force plates (2xAMTI force plates).
7 secondary outcomes
Hip and Lumbar spine range of motion
Time frame: Baseline and first week after 8-week intervention
Shortness of the hip flexor, knee flexor and plantar flexor muscles
Time frame: Baseline and first week after 8-week intervention
Beighton test
Time frame: Baseline and first week after 8-week intervention
Visual analogue scale
Time frame: Baseline and first week after 8-week intervention
Oswestry Disability Index
Time frame: Baseline and first week after 8-week intervention
Roland-Morris Disability Questionnaire
Time frame: Baseline and first week after 8-week intervention
Tampa Kinesiophobia Scale
Time frame: Baseline and first week after 8-week intervention
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 2 Jul 2025.
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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 Functional Neuromuscular Electrical Stimulation and Conventional Neuromuscular Electrical Stimulation in people with Low Back Pain, run by Hacettepe University 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 3 inclusion and 5 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 2 Jul 2025. 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?
Changes in kinematics of the Lumbar Spine and Hip During sit-to-stand activity (time frame: Baseline and first week after 8-week intervention). 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 2 Jul 2025.