Low Back PainNCT05761808
Effect Of Applied Neuromuscular Electrical Stimulation In Addition To Lumber Stabilization Exercises On The Multifidus Muscle Thickness
A study testing exercises and neuromuscular electrical stimulation in people with Low Back Pain, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to show the additive effects of neuromuscular electrical stimulation (NMES) applied to the multifidus muscle in addition to stabilization exercises in patients with chronic 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?
- exercises and neuromuscular electrical stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2023to 1 Sep 2023
- 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
- Low back pain persist more than 3 months
- NRS scale is above 3
- Agree to participation and fill in the consent form
Who cannot join
- radiculopathy
- low back pain persists less than 3 months
- neurological disease
- history of lumber spinal surgery
- pregnancy
- active skin infection
- obesity and morbid obesity (BMI more than 30)
- NMES contraindication
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Sultan 2. Abdulhamıd Han Training and Research Hospital
Istanbul
emre ata, ass. prof., 05336152162, emreata.ftr@gmail.com
About this study
Official title: In Patients With Chronic Low Back Pain, Ultrasonographic Evaluation Of The Effect Of Applied Neuromuscular Electrical Stimulation In Addition To Lumber Stabilization Exercises On The Multifidus Muscle Thickness
The goal of this clinical trial is to show the additive effects of neuromuscular electrical stimulation (NMES) applied to the multifidus muscle in addition to stabilization exercises in patients with chronic low back pain. The main question it aims to answer is:
- Does NMES have additional effects on multifidus muscle thickness? Participants will go under a treatment protocol combination of lumber stabilization exercises and NMES.
Researchers will compare the groups Group 1 which has only lumber stabilization exercises and Group 2 which has both exercises and NMES to see if any changes occur in multifidus muscle thickness.
Read the detailed description
Chronic low back pain is defined as low back pain lasting more than 3 months. Even if the acute pathology causing the pain is treated, chronic low back pain lasting up to 1 year can be seen in 20% of the patients. 80% of the population suffers from chronic low back pain at least once in their life. The causes of chronic low back pain can be very variable. Studies show that 70% of these pains are idiopathic and non-specific, that is, due to lumbar sprain and strain. This is followed by mechanical causes with 27%; spondylosis, spinal stenosis, lumbar disc herniation, osteoporotic fractures, congenital diseases. Apart from these, 2% referred pain; Pain due to malignancy and infection is seen in 1%.
Although the aim of the treatment of chronic low back pain varies according to the patient, the main purpose is to reduce the patient's pain and improve their functions. For this purpose, many treatment programs can be given to the patient. Exercises, physical therapy modalities, pharmacological treatments and surgical methods can be used.
Lumbar stabilization exercises are exercises for the abdominal and dorsal muscles, and many studies have previously shown their positive effects on pain and disability. However, these effects are usually short-term. Therefore, combining stabilization exercises with neuromuscular electrical stimulation (NMES) in patients with chronic low back pain and its clinical effect was questioned. Although this study could not prove the additive effect of NMES statistically, it showed important results on NMES tolerance of patients with chronic low back pain.
Multifudus muscle thickness was measured ultrasonographically in the studies. These studies show that multifidus muscle thickness is reduced in patients with chronic low back pain. Multifidus thickness measurement can be done statically and dynamically with the help of ultrasonography. In a study, static and dynamic multifudus thickness measurements were made at 3 levels (L3-L4, L4-L5, L5-S1), and high reliable results were obtained at L3-L4 and L4-L5 levels, and average reliable results were obtained at L5-S1 levels in static measurements. In dynamic measurements, reliable results were not obtained at all 3 levels.
- Conditions
- Low Back Pain
- Being tested
- exercises, neuromuscular electrical stimulation
- Keywords
- multifidus, ultrasound
- 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.
exercisesOther
Before being included in the study, the multifudus muscle thickness at the L4-L5 level of each patient will be measured ultrasonographically. First of all, exercises to learn transversus abdominis activation will be performed in patients. They will then be included in the stretching and strengthening exercise program. Stretching and strengthening exercises were planned as dynamic abdominal bracing, finding and maintaining neutral position, and exercises on all fours. Exercise therapy will be applied by the same physiotherapist 3 days a week for 5 weeks. Patients will continue to exercise for 7 more weeks as a home program. During this period, they will be called once a week by phone.
neuromuscular electrical stimulationOther
NMES intensity will be planned individually according to the patients. Before being included in the study, the multifudus muscle thickness at the L4-L5 level of each patient will be measured ultrasonographically. NMES application will be applied by a specialist physiotherapist 3 days a week for 5 weeks, for a total of 15 sessions. Exercises will be applied 3 days a week for 5 weeks, accompanied by a physiotherapist. Patients will continue to exercise for 7 more weeks as a home program. In this process, patients will be called once a week by phone.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Group | Active comparator | Lumbar stabilization exercises constitute the first step of treatment in chronic low back pain. Receives: Other: exercises |
| NMES Group | Active comparator | NMES will be applied in addition to lumbar stabilization exercises. Receives: Other: neuromuscular electrical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
multifudus muscle thickness
A curve probe is used for ultrasound imaging. Patients are placed prone on the examination table. A pillow is placed under the abdomen to keep the lumbosacral junction angle below 10 degrees. After visualizing the L4 spinous process in the parasagittal plane, the L4-L5 facet joint is seen by moving 2 cm laterally from the midline. Probe angulation is done to get a clearer image.
Measured: 3 months
Secondary outcomes (1)
low back pain change
Numeric rating scale (NRS) is used to convert some values that cannot be measured numerically to numeric. Two end definitions of the parameter to be evaluated are written at the two ends of a 100 mm line, and the patient is asked to indicate where on this line their situation is appropriate by drawing a line or by placing a dot or pointing. For example, for pain, I have no pain at one end and very severe pain at the other end, and the patient marks his/her current state on this line. The length of the distance from the point where there is no pain to the point marked by the patient indicates the patient's pain.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2023
- Study start1 Mar 2023
- Primary completion1 Sep 2023 (estimated)
- Study completion1 Sep 2023 (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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- emre ata, Ass. Prof., Study director, Sultan 2. Abdulhamid Han Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05761808
- Sponsor's protocol ID
- 2259
- Status last verified
- Jun 2023
- First submitted
- 27 Feb 2023
- Last updated
- 6 Jun 2023
- 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 6 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Patients With Chronic Low Back Pain, Ultrasonographic Evaluation Of The Effect Of Applied Neuromuscular Electrical Stimulation In Addition To Lumber Stabilization Exercises On The Multifidus Muscle Thickness
- ClinicalTrials.gov ID
- NCT05761808
- Acronym / sponsor ID
- 2259
- Conditions
- Low Back Pain
- Keywords
- multifidus, ultrasound
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, TurkeyUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 1 Sep 2023 (estimated)
- First posted
- 9 Mar 2023 (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 clinical trial is to show the additive effects of neuromuscular electrical stimulation (NMES) applied to the multifidus muscle in addition to stabilization exercises in patients with chronic low back pain. The main question it aims to answer is:
- Does NMES have additional effects on multifidus muscle thickness? Participants will go under a treatment protocol combination of lumber stabilization exercises and NMES.
Researchers will compare the groups Group 1 which has only lumber stabilization exercises and Group 2 which has both exercises and NMES to see if any changes occur in multifidus muscle thickness.
Detailed description
Chronic low back pain is defined as low back pain lasting more than 3 months. Even if the acute pathology causing the pain is treated, chronic low back pain lasting up to 1 year can be seen in 20% of the patients. 80% of the population suffers from chronic low back pain at least once in their life. The causes of chronic low back pain can be very variable. Studies show that 70% of these pains are idiopathic and non-specific, that is, due to lumbar sprain and strain. This is followed by mechanical causes with 27%; spondylosis, spinal stenosis, lumbar disc herniation, osteoporotic fractures, congenital diseases. Apart from these, 2% referred pain; Pain due to malignancy and infection is seen in 1%.
Although the aim of the treatment of chronic low back pain varies according to the patient, the main purpose is to reduce the patient's pain and improve their functions. For this purpose, many treatment programs can be given to the patient. Exercises, physical therapy modalities, pharmacological treatments and surgical methods can be used.
Lumbar stabilization exercises are exercises for the abdominal and dorsal muscles, and many studies have previously shown their positive effects on pain and disability. However, these effects are usually short-term. Therefore, combining stabilization exercises with neuromuscular electrical stimulation (NMES) in patients with chronic low back pain and its clinical effect was questioned. Although this study could not prove the additive effect of NMES statistically, it showed important results on NMES tolerance of patients with chronic low back pain.
Multifudus muscle thickness was measured ultrasonographically in the studies. These studies show that multifidus muscle thickness is reduced in patients with chronic low back pain. Multifidus thickness measurement can be done statically and dynamically with the help of ultrasonography. In a study, static and dynamic multifudus thickness measurements were made at 3 levels (L3-L4, L4-L5, L5-S1), and high reliable results were obtained at L3-L4 and L4-L5 levels, and average reliable results were obtained at L5-S1 levels in static measurements. In dynamic measurements, reliable results were not obtained at all 3 levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise Group | Active comparator | Other: exercisesLumbar stabilization exercises constitute the first step of treatment in chronic low back pain. |
| NMES Group | Active comparator | Other: neuromuscular electrical stimulationNMES will be applied in addition to lumbar stabilization exercises. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Low back pain persist more than 3 months
- NRS scale is above 3
- Agree to participation and fill in the consent form
Key exclusion criteria (8 listed)
- radiculopathy
- low back pain persists less than 3 months
- neurological disease
- history of lumber spinal surgery
- 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 |
|---|---|---|
| exercisesBefore being included in the study, the multifudus muscle thickness at the L4-L5 level of each patient will be measured ultrasonographically. First of all, exercises to learn transversus abdominis activation will be performed in patients. They will then be included in the stretching and strengthening exercise program. Stretching and strengthening exercises were planned as dynamic abdominal bracing, finding and maintaining neutral position, and exercises on all fours. Exercise therapy will be applied by the same physiotherapist 3 days a week for 5 weeks. Patients will continue to exercise for 7 more weeks as a home program. During this period, they will be called once a week by phone. | Other | Exercise Group |
| neuromuscular electrical stimulationNMES intensity will be planned individually according to the patients. Before being included in the study, the multifudus muscle thickness at the L4-L5 level of each patient will be measured ultrasonographically. NMES application will be applied by a specialist physiotherapist 3 days a week for 5 weeks, for a total of 15 sessions. Exercises will be applied 3 days a week for 5 weeks, accompanied by a physiotherapist. Patients will continue to exercise for 7 more weeks as a home program. In this process, patients will be called once a week by phone. | Other | NMES Group |
Primary outcome
multifudus muscle thickness
Time frame: 3 months
A curve probe is used for ultrasound imaging. Patients are placed prone on the examination table. A pillow is placed under the abdomen to keep the lumbosacral junction angle below 10 degrees. After visualizing the L4 spinous process in the parasagittal plane, the L4-L5 facet joint is seen by moving 2 cm laterally from the midline. Probe angulation is done to get a clearer image.
1 secondary outcome
low back pain change
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2023.
- 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.
emre ata, Ass. Prof. study director
Sultan 2. Abdulhamid Han Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercises and neuromuscular electrical stimulation in people with Low Back Pain, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey 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 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: status not confirmed, as of the sponsor's last update on 6 Jun 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact emre ata, Ass. Prof. (5336152162, emreata.ftr@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
multifudus muscle thickness (time frame: 3 months). 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 6 Jun 2023.