Low Back PainNCT06752213
Comparison of Manual Therapy and Auricular Vagus Nerve Stimulation in Chronic Low Back Pain
A study testing Vagus nerve Stimulation and Manual therapy in people with Low Back Pain and Pain, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
Especially in the elderly population, low back pain is a major health problem, causing great human costs, negatively affecting the quality of life and limiting the daily activities of individuals Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Low Back Pain, Pain
- What is being tested?
- Vagus nerve Stimulation and Manual therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Jan 2025to 21 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Cognitive impairment
- Severe osteoprosis
- Neurological deficit
- Being pregnant
- Operations on the lumbar region
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Manual Therapy and Auricular Vagus Nerve Stimulation in Chronic Low Back Pain: A Crossover Study
Especially in the elderly population, low back pain is a major health problem, causing great human costs, negatively affecting the quality of life and limiting the daily activities of individuals
- Conditions
- Low Back Pain, Pain
- Being tested
- Vagus nerve Stimulation, Manual therapy
- Keywords
- pain, low back pain
- Medical subject headings
- Low Back Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vagus nerve StimulationDevice
Vagus nerve Stimulation
Manual therapyOther
Manual therapy
| Study group | Role | What they receive |
|---|---|---|
| Vagus nerve Stimulation | Experimental | Vagus nerve Stimulation Receives: Device: Vagus nerve Stimulation; Other: Manual therapy |
| Manual therapy | Experimental | manual therapy Receives: Device: Vagus nerve Stimulation; Other: Manual therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle Endurance Assessment
Trunk Extensor Muscle Endurance To assess the endurance of the back extensor muscles, participants will lie prone on a table with their lower extremities stabilized. The trunk will hang off the table at the level of the anterior-superior iliac spine. At the start of the test, hands will be placed on a chair. Upon beginning, participants will position their arms alongside their trunk, holding their body parallel to the floor. The duration for which this position is maintained without breaking posture will be recorded in seconds.
Trunk Flexor Muscle Endurance Participants will begin in a supine position with knees flexed and arms crossed over the chest. Starting from a 60-degree trunk flexion position, they will be asked to hold this posture. The legs will be stabilized at the knees, and the time the position is maintained will be recorded in seconds.
Measured: 6 weeks
Autonomic Nervous System Assessment
Heart rate variability will be measured using the Polar H7 heart rate sensor with a chest strap and wrist monitor (Polar H7, Polar Electro Oy). The chest strap will be placed over the sternum, and heart rate data will be recorded before and after auricular VNS. This method is validated against electrocardiogram measurements.
Measured: 6 weeks
Flamingo Balance Test
The Flamingo Balance Test, part of the Eurofit test battery, uses a stopwatch and a 50 cm-long, 4 cm-high, and 3 cm-wide wooden beam. Participants stand on their non-dominant leg on the beam, holding the opposite leg's knee in maximal flexion with the corresponding hand while focusing on a fixed point at eye level. The timer starts once the participant releases the examiner's hand and stops when balance is lost or the body touches the ground. The test is repeated three times, and the average score is recorded.
Measured: 6 weeks
Modified Star Excursion Balance
Y-shape, with the anterior direction at 0° and the posteromedial and posterolateral directions set at 135° and 90° angles, respectively. Participants will stand on their dominant leg, maintaining balance while reaching with the non-dominant leg as far as possible in each direction. They will then return to the starting position. Four practice trials will be provided, followed by three test trials in each direction. The average of the test trials will be recorded.
Measured: 6 weeks
Algometer
A digital algometer (Wagner Force Ten FDX 50 Wagner Instruments, Greenwich, CT) will be used to objectively assess pain threshold and tolerance. Measurements will be conducted on the most painful taut band within the trigger point identified during diagnostic evaluation. A 1 cm² disk probe will apply pressure until the participant signals the first sensation of pain by saying "stop."
Measured: 6 weeks
Visual Analog Scale (VAS)
The VAS was used to assess pain intensity before and after treatment. Patients marked their pain level on a 10 cm line, with 0 representing no pain and 10 representing unbearable pain. The distance from the 0-point to the mark was measured in centimeters and recorded.
Measured: 6 weeks
Oswestry Disability Index (ODI)
The Turkish version of the ODI is frequently used in clinical practice to evaluate functional disability in individuals with low back pain. The 10-item questionnaire assesses pain and daily living activities, with each item scored from 0 to 5. The total score is calculated using the formula: (Total score/Maximum score) × 100. Higher scores indicate greater disability.
Measured: 6 weeks
Range of Motion and Mobility Assessment
Trunk flexion and extension ROM measurements will be performed using the Angles Video Goniometer app for iPhone™ (Angles app, © 2020 Nathaniel Joseph Cochran). For lumbar mobility evaluation, the modified Schober test and fingertip-to-floor distance (FTFD) test will be utilized.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2024
- Study start6 Jan 2025
- Primary completion20 Feb 2025
- Study completion21 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.
- 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
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, hazal genc, Istanbul Medipol University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06752213
- Sponsor's protocol ID
- E-10840098-202.3.02-2797
- Status last verified
- Aug 2025
- First submitted
- 21 Dec 2024
- Last updated
- 12 Aug 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 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Manual Therapy and Auricular Vagus Nerve Stimulation in Chronic Low Back Pain: A Crossover Study
- ClinicalTrials.gov ID
- NCT06752213
- Acronym / sponsor ID
- E-10840098-202.3.02-2797
- Conditions
- Low Back Pain, Pain
- Keywords
- pain, low back pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 6 Jan 2025 (actual)
- Primary completion
- 20 Feb 2025 (actual)
- Study completion
- 21 Jun 2025 (actual)
- First posted
- 30 Dec 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.
Especially in the elderly population, low back pain is a major health problem, causing great human costs, negatively affecting the quality of life and limiting the daily activities of individuals
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vagus nerve Stimulation | Experimental | Device: Vagus nerve Stimulation, Other: Manual therapyVagus nerve Stimulation |
| Manual therapy | Experimental | Device: Vagus nerve Stimulation, Other: Manual therapymanual therapy |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- Cognitive impairment
- Severe osteoprosis
- Neurological deficit
- Being pregnant
- Operations on the lumbar region
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 nerve StimulationVagus nerve Stimulation | Device | Manual therapy, Vagus nerve Stimulation |
| Manual therapyManual therapy | Other | Manual therapy, Vagus nerve Stimulation |
Primary outcome
Muscle Endurance Assessment
Time frame: 6 weeks
Trunk Extensor Muscle Endurance To assess the endurance of the back extensor muscles, participants will lie prone on a table with their lower extremities stabilized. The trunk will hang off the table at the level of the anterior-superior iliac spine. At the start of the test, hands will be placed on a chair. Upon beginning, participants will position their arms alongside their trunk, holding their body parallel to the floor. The duration for which this position is maintained without breaking posture will be recorded in seconds. Trunk Flexor Muscle Endurance Participants will begin in a supine position with knees flexed and arms crossed over the chest. Starting from a 60-degree trunk flexion position, they will be asked to hold this posture. The legs will be stabilized at the knees, and the time the position is maintained will be recorded in seconds.
Autonomic Nervous System Assessment
Time frame: 6 weeks
Heart rate variability will be measured using the Polar H7 heart rate sensor with a chest strap and wrist monitor (Polar H7, Polar Electro Oy). The chest strap will be placed over the sternum, and heart rate data will be recorded before and after auricular VNS. This method is validated against electrocardiogram measurements.
Flamingo Balance Test
Time frame: 6 weeks
The Flamingo Balance Test, part of the Eurofit test battery, uses a stopwatch and a 50 cm-long, 4 cm-high, and 3 cm-wide wooden beam. Participants stand on their non-dominant leg on the beam, holding the opposite leg's knee in maximal flexion with the corresponding hand while focusing on a fixed point at eye level. The timer starts once the participant releases the examiner's hand and stops when balance is lost or the body touches the ground. The test is repeated three times, and the average score is recorded.
Modified Star Excursion Balance
Time frame: 6 weeks
Y-shape, with the anterior direction at 0° and the posteromedial and posterolateral directions set at 135° and 90° angles, respectively. Participants will stand on their dominant leg, maintaining balance while reaching with the non-dominant leg as far as possible in each direction. They will then return to the starting position. Four practice trials will be provided, followed by three test trials in each direction. The average of the test trials will be recorded.
Algometer
Time frame: 6 weeks
A digital algometer (Wagner Force Ten FDX 50 Wagner Instruments, Greenwich, CT) will be used to objectively assess pain threshold and tolerance. Measurements will be conducted on the most painful taut band within the trigger point identified during diagnostic evaluation. A 1 cm² disk probe will apply pressure until the participant signals the first sensation of pain by saying "stop."
Visual Analog Scale (VAS)
Time frame: 6 weeks
The VAS was used to assess pain intensity before and after treatment. Patients marked their pain level on a 10 cm line, with 0 representing no pain and 10 representing unbearable pain. The distance from the 0-point to the mark was measured in centimeters and recorded.
Oswestry Disability Index (ODI)
Time frame: 6 weeks
The Turkish version of the ODI is frequently used in clinical practice to evaluate functional disability in individuals with low back pain. The 10-item questionnaire assesses pain and daily living activities, with each item scored from 0 to 5. The total score is calculated using the formula: (Total score/Maximum score) × 100. Higher scores indicate greater disability.
Range of Motion and Mobility Assessment
Time frame: 6 weeks
Trunk flexion and extension ROM measurements will be performed using the Angles Video Goniometer app for iPhone™ (Angles app, © 2020 Nathaniel Joseph Cochran). For lumbar mobility evaluation, the modified Schober test and fingertip-to-floor distance (FTFD) test will be utilized.
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 12 Aug 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 Vagus nerve Stimulation and Manual therapy in people with Low Back Pain and 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 0 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 12 Aug 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?
Muscle Endurance Assessment (time frame: 6 weeks). The study lists 8 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 12 Aug 2025.