Low Back PainNCT05646173
Efficacy of Auricular Vagus Nerve Stimulation and Electrotherapy Modalities in Patients With Chronic Low Back Pain
A study testing vagus stimülation device, Electrophysical agents and home exercise program in people with Low Back Pain, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of our study is to compare the effectiveness of auricular vagus nerve stimulation and conventional physical therapy in patients with Chronic Low Back Pain (CBA). 60 patients, aged between 18 and 60, with persistent low back pain for the last 3 months and who voluntarily agreed to participate in the study will… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Low Back Pain
- What is being tested?
- vagus stimülation device, Electrophysical agents and home exercise program
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Nov 2022to 27 Mar 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- be between the ages of 20-60
- volunteering to work
- Having low back pain for more than 3 months
- Diagnosis of chronic low back pain by the doctor
- Being able to read and write and be cooperative.
- Not having received treatment for the lumbar region in the last 3 months
Who cannot join
- Not having any lumbar surgery or vertebral fracture
- Being neurological, radiculopathy, inflammatory etc disease
- Having spinal deformities such as scoliosis or kyphosis
- Vestibular or respiratory disorder, Auditory or cognitive impairment
- Taking medication that will affect the balance (sedatives, etc.)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gamze Demircioglu
Istanbul, Istanbul Avrupa Kitasi, 34353
About this study
Official title: Comparison of the Efficacy of Auricular Vagus Nerve Stimulation and Electrotherapy Modalities in Chronic Low Back Pain
The aim of our study is to compare the effectiveness of auricular vagus nerve stimulation and conventional physical therapy in patients with Chronic Low Back Pain (CBA). 60 patients, aged between 18 and 60, with persistent low back pain for the last 3 months and who voluntarily agreed to participate in the study will be included in the study. Patients will be randomly divided into two groups as conventional therapy (Group I) and auricular vagus stimulation therapy (Group II). Patient Identification Form, Oswestry Disability Index, Lumbal Region Joint Range of Motion and Mobility (Inclinometer, Modified Schober Test, Hand Finger-Ground Distance Test), muscle strength (CSMI-Cybex Humac-Norm isokinetic dynamometer and Lafayette manual muscle strength measuring device) in the evaluation of patients with CKD and endurance tests, postural control and balance assessment (BBS, Biodex Medical Systems), Visual Analogue Scale (VAS), Beck Depression Inventory (BDI), Pittsburgh Sleep Quality Scale (PUKÖ). After the measurements on the 1st day, 15 sessions of application and the measurements will be repeated the day after the last session. A home exercise program will be created for the patients in both groups. Statistical analysis will be calculated using SPSS for Windows 22 program.
Read the detailed description
Low back pain is one of the common problems that 80% of people experience at least once in their lifetime. Treatment of chronic low back pain includes surgical treatment, medical treatment and conservative treatment. The aim of conservative treatment is to raise the patient to the best possible level. Evidence levels for approaches commonly used in the clinic for the treatment of chronic low back pain were generally very low to moderate. It has been stated that the success of treatment is low in patients who are taken to conventional rehabilitation in the clinic, due to the lack of personal programs and the problems caused by the lack of human resources and space.
In recent studies, it has been shown that vagal nerve stimulation modulates peripheral and central nociceptive functions and reduces pain response. As a result, it was found that the pain threshold increased and the mechanical pain sensitivity decreased.
When we look at the literature; Although there are many studies on the treatment of chronic low back pain, there are no studies on the use of vagus nerve stimulation. Vagus nerve stimulation can be used as an adjunct therapy to correct autonomic nerve dysfunction.
- Conditions
- Low Back Pain
- Being tested
- vagus stimülation device, Electrophysical agents, home exercise program
- Keywords
- vagus nerve stimülation
- 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.
vagus stimülation deviceDevice
Vagustim is a wearable medical technology device that focuses on non-invasive bilateral auricular vagus nerve stimulation (VNS). VNS is a clinically approved, safe and effective neuromodulation method.
Electrophysical agentsDevice
Electrophysical agents (EPAs) are those modalities that administer thermal, mechanical, electrical or light energy to the patient to provide physiological effects and therapeutic benefits.
home exercise programOther
The home exercise program will be explained to the patients by the physiotherapist and will also be given to the patient in the form of a brochure. Patients will be instructed to do the exercises regularly, three times a day for ten repetitions each day. The content of the exercises is updated weekly.
| Study group | Role | What they receive |
|---|---|---|
| grup 1 | Active comparator | Grup 1: Participants will be treated with ultrasound (5 min), TENS with a hot pack for (20 minutes). Home exercises will be given. The home exercises will be given consist of isometric waist, hip flexor stretching, hamstring stretching, self-mobilization exercise, waist and abdominal concentric strength exercises.
1.5w/cm² continuous ultrasound wiil applied with Chattanooga Intelect Mobile Ultrasound device.TENS: It will be applied to the lumbar region with a COMPEX brand stim device, together with a hot pack.The current intensity was opened by questioning according to the sensory threshold of the people.
Home based exercise program:In the first week of the exercise program; isometric exercises, stretching and mobilization exercises were given. Second week; additional bridging exercise; In the third week, additional isotonic, active abdominal and back strengthening exercises were included in all exercises.
The application will be done in 15 sessions, 5 days a week Receives: Device: Electrophysical agents; Other: home exercise program |
| grup 2 | Experimental | Grup 2: Participants will be given auricular vagus stimulation (25 min). Home exercises will be given. The home exercises will be given consist of isometric waist, hip flexor stretching, hamstring stretching, self-mobilization exercise, waist and abdominal concentric strength exercises.
Vagus stimulation: A specially manufactured earphone that can be selected according to the size of the ear placed in the outer ear will be applied from the vagustim device (frequency 10 Hz, pulse duration less than 500 microseconds, in modulated TENS mode and biphasic asymmetric waveform) connected to it.
Home based exercise program: In the first week of the exercise program; isometric exercises, stretching and mobilization exercises were given. Second week; additional bridging exercise; In the third week, additional isotonic, active abdominal and back strengthening exercises were included in all exercises.
The application will be done in 15 sessions, 5 days a week. Receives: Device: vagus stimülation device; Other: home exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oswestry Disability Index (ODİ)
The Oswestry Disability Index is the most commonly used outcome-measure questionnaire for low back pain in a hospital setting. Each section is scored on a 0-5 scale, 5 representing the greatest disability. The index is calculated by dividing the summed score by the total possible score, which is then multiplied by 100 and expressed as a percentage. Thus, for every question not answered, the denominator is reduced by 5. A score of 0-20 reflects minimal disability, 21-40 moderate disability, 41-60 severe disability, 61-80 crippled, and 81-100 bed-bound.
Measured: 3 week
Secondary outcomes (9)
Lumbal Region Joint Range of Motion
we will use Inclinometer.
Measured: 3 week
Modified Schober Test,
Schober's test is a physical examination used in family medicine, physical medicine and rehabilitation, rheumatology to measure the ability of a patient to flex the lower back.
Measured: 3 week
trunk muscle strength (Lafayette manual muscle strength measuring device)
The Lafayette Manual Muscle Tester (MMT) is an ergonomic hand-held device for objectively quantifying muscle strength. Tests are performed with the clinician applying force to the limb of a patient. The objective is for the clinician to overcome or "break" the patient's resistance.
Measured: 3 week
lower body muscle strength (CSMI-Cybex Humac-Norm isokinetic dynamometer)
A CYBEX Isokinetic Test is used to measure the maximum strength of a joint throughout its available range-of-motion (ROM).
Measured: 3 week
trunk muscle endurance
Trunk muscle endurance of the subjects was evaluated using flexor endurance and Sorensen tests.
Measured: 3 week
Balance assessment (BBS, Biodex Medical Systems),
Using this unique device, clinicians can assess neuromuscular control by quantifying the ability to maintain dynamic bilateral and unilateral postural stability on a static or unstable surface. Use any of four test protocols including fall risk, athletic single leg stability, limits of stability and postural stability.
Measured: 3 week
Visual Analogue Scale (VAS)
The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain.
Measured: 3 week
The Beck Depression Inventory (BDI)
The Beck Depression Inventory (BDI) is a 21-item self-reporting questionnaire for evaluating the severity of depression in normal and psychiatric populations. The Beck Depression Inventory (BDI) is a 21-item, multiple-choice inventory. Respondents are asked to rate each item based on four response choices according to the severity of the symptoms, ranging from the absence of a symptom to an intense level, during the past week. Individual scale items are scored on a 4-point continuum (0=least, 3=most), with a total summed score range of 0-63. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.
Measured: 3 week
The Pittsburgh Sleep Quality Index (PSQI)
The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval. Each of the sleep components yields a score ranging from 0 to 3, with 3 indicating the greatest dysfunction. The sleep component scores are summed to yield a total score ranging from 0 to 21 with the higher total score (referred to as global score) indicating worse sleep quality.
Measured: 3 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2022
- Study start11 Nov 2022
- Primary completion8 Feb 2023
- Study completion27 Mar 2023
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
- 60 patients, aged between 18 and 60, with persistent low back pain who voluntarily agreed to participate in the study will be included in the study. Patient Identification Form, Lumbal Region Joint Range of Motion and Mobility (Inclinometer, Modified Schober Test), muscle strength (CSMI-Cybex Humac-Norm isokinetic dynamometer and manual muscle strength measuring device) in the evaluation of patients with CKD and endurance tests, postural control and balance assessment (BBS, Biodex Medical Systems), Visual Analogue Scale (VAS), Beck Depression Inventory (BDI), Pittsburgh Sleep Quality Scale (PUKÖ), Oswestry Disability Index. Statistical analysis will be calculated using SPSS for Windows 22 program.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- gamze demircioğlu, phd(c), Principal investigator, istanbul medipol hastanesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05646173
- Sponsor's protocol ID
- low back pain
- Status last verified
- Oct 2022
- First submitted
- 18 Oct 2022
- Last updated
- 11 Apr 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 11 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Auricular Vagus Nerve Stimulation and Electrotherapy Modalities in Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT05646173
- Acronym / sponsor ID
- low back pain
- Conditions
- Low Back Pain
- Keywords
- vagus nerve stimülation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 11 Nov 2022 (actual)
- Primary completion
- 8 Feb 2023 (actual)
- Study completion
- 27 Mar 2023 (actual)
- First posted
- 12 Dec 2022 (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 aim of our study is to compare the effectiveness of auricular vagus nerve stimulation and conventional physical therapy in patients with Chronic Low Back Pain (CBA). 60 patients, aged between 18 and 60, with persistent low back pain for the last 3 months and who voluntarily agreed to participate in the study will be included in the study. Patients will be randomly divided into two groups as conventional therapy (Group I) and auricular vagus stimulation therapy (Group II). Patient Identification Form, Oswestry Disability Index, Lumbal Region Joint Range of Motion and Mobility (Inclinometer, Modified Schober Test, Hand Finger-Ground Distance Test), muscle strength (CSMI-Cybex Humac-Norm isokinetic dynamometer and Lafayette manual muscle strength measuring device) in the evaluation of patients with CKD and endurance tests, postural control and balance assessment (BBS, Biodex Medical Systems), Visual Analogue Scale (VAS), Beck Depression Inventory (BDI), Pittsburgh Sleep Quality Scale (PUKÖ). After the measurements on the 1st day, 15 sessions of application and the measurements will be repeated the day after the last session. A home exercise program will be created for the patients in both groups. Statistical analysis will be calculated using SPSS for Windows 22 program.
Detailed description
Low back pain is one of the common problems that 80% of people experience at least once in their lifetime. Treatment of chronic low back pain includes surgical treatment, medical treatment and conservative treatment. The aim of conservative treatment is to raise the patient to the best possible level. Evidence levels for approaches commonly used in the clinic for the treatment of chronic low back pain were generally very low to moderate. It has been stated that the success of treatment is low in patients who are taken to conventional rehabilitation in the clinic, due to the lack of personal programs and the problems caused by the lack of human resources and space.
In recent studies, it has been shown that vagal nerve stimulation modulates peripheral and central nociceptive functions and reduces pain response. As a result, it was found that the pain threshold increased and the mechanical pain sensitivity decreased.
When we look at the literature; Although there are many studies on the treatment of chronic low back pain, there are no studies on the use of vagus nerve stimulation. Vagus nerve stimulation can be used as an adjunct therapy to correct autonomic nerve dysfunction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 60 patients, aged between 18 and 60, with persistent low back pain who voluntarily agreed to participate in the study will be included in the study. Patient Identification Form, Lumbal Region Joint Range of Motion and Mobility (Inclinometer, Modified Schober Test), muscle strength (CSMI-Cybex Humac-Norm isokinetic dynamometer and manual muscle strength measuring device) in the evaluation of patients with CKD and endurance tests, postural control and balance assessment (BBS, Biodex Medical Systems), Visual Analogue Scale (VAS), Beck Depression Inventory (BDI), Pittsburgh Sleep Quality Scale (PUKÖ), Oswestry Disability Index. Statistical analysis will be calculated using SPSS for Windows 22 program.
| Arm | Type | Receives |
|---|---|---|
| grup 1 | Active comparator | Device: Electrophysical agents, Other: home exercise programGrup 1: Participants will be treated with ultrasound (5 min), TENS with a hot pack for (20 minutes). Home exercises will be given. The home exercises will be given consist of isometric waist, hip flexor stretching, hamstring stretching, self-mobilization exercise, waist and abdominal concentric strength exercises. 1.5w/cm² continuous ultrasound wiil applied with Chattanooga Intelect Mobile Ultrasound device.TENS: It will be applied to the lumbar region with a COMPEX brand stim device, together with a hot pack.The current intensity was opened by questioning according to the sensory threshold of the people. Home based exercise program:In the first week of the exercise program; isometric exercises, stretching and mobilization exercises were given. Second week; additional bridging exercise; In the third week, additional isotonic, active abdominal and back strengthening exercises were included in all exercises. The application will be done in 15 sessions, 5 days a week |
| grup 2 | Experimental | Device: vagus stimülation device, Other: home exercise programGrup 2: Participants will be given auricular vagus stimulation (25 min). Home exercises will be given. The home exercises will be given consist of isometric waist, hip flexor stretching, hamstring stretching, self-mobilization exercise, waist and abdominal concentric strength exercises. Vagus stimulation: A specially manufactured earphone that can be selected according to the size of the ear placed in the outer ear will be applied from the vagustim device (frequency 10 Hz, pulse duration less than 500 microseconds, in modulated TENS mode and biphasic asymmetric waveform) connected to it. Home based exercise program: In the first week of the exercise program; isometric exercises, stretching and mobilization exercises were given. Second week; additional bridging exercise; In the third week, additional isotonic, active abdominal and back strengthening exercises were included in all exercises. The application will be done in 15 sessions, 5 days a week. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- be between the ages of 20-60
- volunteering to work
- Having low back pain for more than 3 months
- Diagnosis of chronic low back pain by the doctor
- Being able to read and write and be cooperative.
Key exclusion criteria (5 listed)
- Not having any lumbar surgery or vertebral fracture
- Being neurological, radiculopathy, inflammatory etc disease
- Having spinal deformities such as scoliosis or kyphosis
- Vestibular or respiratory disorder, Auditory or cognitive impairment
- Taking medication that will affect the balance (sedatives, etc.)
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 |
|---|---|---|
| vagus stimülation deviceVagustim is a wearable medical technology device that focuses on non-invasive bilateral auricular vagus nerve stimulation (VNS). VNS is a clinically approved, safe and effective neuromodulation method. | Device | grup 2 |
| Electrophysical agentsElectrophysical agents (EPAs) are those modalities that administer thermal, mechanical, electrical or light energy to the patient to provide physiological effects and therapeutic benefits. | Device | grup 1 |
| home exercise programThe home exercise program will be explained to the patients by the physiotherapist and will also be given to the patient in the form of a brochure. Patients will be instructed to do the exercises regularly, three times a day for ten repetitions each day. The content of the exercises is updated weekly. | Other | grup 1, grup 2 |
Primary outcome
Oswestry Disability Index (ODİ)
Time frame: 3 week
The Oswestry Disability Index is the most commonly used outcome-measure questionnaire for low back pain in a hospital setting. Each section is scored on a 0-5 scale, 5 representing the greatest disability. The index is calculated by dividing the summed score by the total possible score, which is then multiplied by 100 and expressed as a percentage. Thus, for every question not answered, the denominator is reduced by 5. A score of 0-20 reflects minimal disability, 21-40 moderate disability, 41-60 severe disability, 61-80 crippled, and 81-100 bed-bound.
9 secondary outcomes
Lumbal Region Joint Range of Motion
Time frame: 3 week
Modified Schober Test,
Time frame: 3 week
trunk muscle strength (Lafayette manual muscle strength measuring device)
Time frame: 3 week
lower body muscle strength (CSMI-Cybex Humac-Norm isokinetic dynamometer)
Time frame: 3 week
trunk muscle endurance
Time frame: 3 week
Balance assessment (BBS, Biodex Medical Systems),
Time frame: 3 week
Visual Analogue Scale (VAS)
Time frame: 3 week
The Beck Depression Inventory (BDI)
Time frame: 3 week
The Pittsburgh Sleep Quality Index (PSQI)
Time frame: 3 week
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 11 Apr 2023.
- Individual participant dataSharing planned: No
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Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
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Comparing Non-Medicine Strategies for Improving Low Back Pain
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Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
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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.
gamze demircioğlu, phd(c) principal investigator
istanbul medipol hastanesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vagus stimülation device, Electrophysical agents and home exercise program in people with Low Back Pain, run by Istanbul Medipol University Hospital 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 6 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 11 Apr 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?
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?
Oswestry Disability Index (ODİ) (time frame: 3 week). 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 11 Apr 2023.