Myofascial Pain SyndromeNCT07045324
Effect of Vagus Nerve Stimulation on Trapezius Trigger Point
A study testing Vagus Nerve Stimulation (nVNS) and Ischemic Compression in people with Myofascial Pain Syndrome and Trigger Points, run by Bahçeşehir University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial aimed to evaluate the efficacy of non-invasive vagus nerve stimulation (nVNS) compared to ischemic compression (trigger point massage) and exercise in treating trigger points in the upper trapezius muscle. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Myofascial Pain Syndrome, Trigger Points
- What is being tested?
- Vagus Nerve Stimulation (nVNS) and Ischemic Compression
- Type of treatment
- Medical device, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2025to 25 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-55 years.
- Presence of at least two trigger points (active or latent) in the upper trapezius muscle, confirmed by palpation.
- Ability to provide informed consent.
Who cannot join
- History of cervical spine surgery or trauma.
- Neurological disorders (e.g., epilepsy, stroke).
- Pregnancy or breastfeeding.
- Use of pacemakers or other implanted electrical devices.
- Active infection or skin lesions at the stimulation site.
- Recent use of botulinum toxin or other trigger point injections.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bahçeşehir University, Physiotherapy and Rehabilitation
Istanbul, Helthy, 34353
About this study
Official title: A Comparative Study on the Effect of Vagus Nerve Stimulation and Ischemic Compression on Trapezius Trigger Points
This randomized controlled trial aimed to evaluate the efficacy of non-invasive vagus nerve stimulation (nVNS) compared to ischemic compression (trigger point massage) and exercise in treating trigger points in the upper trapezius muscle. Ninety participants aged 18-55 with at least two trigger points were randomly assigned to three groups: nVNS, ischemic compression, or exercise (control). Interventions were administered over 10 sessions (3 times per week). Outcomes included pain intensity (Visual Analog Scale, VAS), trigger point number, pain pressure threshold (algometer), neck function (Copenhagen Neck Functional Disability Scale, KBFÖS), well-being (WHO-5 Well-Being Index), and functional mobility. The nVNS group demonstrated statistically significant improvements in all outcomes compared to the other groups (p < 0.05).
Read the detailed description
Myofascial pain syndrome (MPS) is characterized by trigger points-hyperirritable spots in skeletal muscle associated with pain, stiffness, and reduced function. The upper trapezius muscle is a common site for trigger points, contributing to neck pain and disability. Traditional treatments include ischemic compression and exercise, but non-invasive vagus nerve stimulation (nVNS) has emerged as a promising modality due to its ability to modulate pain pathways and autonomic function.
This study investigated whether nVNS is more effective than ischemic compression or exercise in reducing pain and improving function in patients with trapezius trigger points. Participants were randomized into three groups (n=30 each)
- Conditions
- Myofascial Pain Syndrome, Trigger Points
- Being tested
- Vagus Nerve Stimulation (nVNS), Ischemic Compression, Exercise (Control)
- Keywords
- Trigger points, Vagus Nerve Stimulation, Parasympathetic System
- Medical subject headings
- Myofascial Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vagus Nerve Stimulation (nVNS)Device
Arm 1 (Vagus Nerve Stimulation (nVNS)) is an experimental intervention, as it tests a novel approach (non-invasive vagus nerve stimulation) for trigger point treatment.
Ischemic CompressionProcedure or surgery
Arm 2 (Ischemic Compression) is an active comparator, as it uses a standard treatment (trigger point massage) commonly applied for myofascial pain.
Exercise (Control)Behavioural
Arm 3 (Exercise (Control)) is explicitly labeled as the control group in your document, using a standard exercise program, which aligns with an active comparator (since it's an active intervention rather than a placebo or no intervention).
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Vagus Nerve Stimulation (nVNS) | Experimental | Participants receive non-invasive auricular vagus nerve stimulation bilaterally to the concha and tragus using a TENS-based device (10 Hz, 300 µs, 20 minutes per session) for 10 sessions over 4 weeks, with intensity adjusted to patient comfort. Receives: Device: Vagus Nerve Stimulation (nVNS) |
| Arm 2: Ischemic Compression | Active comparator | Participants receive manual trigger point massage (ischemic compression) applied to trapezius trigger points for 30-90 seconds per point, 3 times per week for 10 sessions. Receives: Procedure: Ischemic Compression |
| Exercise (Control) | Active comparator | Participants perform a standardized exercise program including isometric neck exercises, upper trapezius stretching, and chin tuck exercises, conducted 3 times per week for 10 sessions. Receives: Behavioral: Exercise (Control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity (VAS)(Visual Analog Scale )
Measured using the Visual Analog Scale (0-10 ), where 0 indicates no pain and 10 indicates worst possible pain.
Measured: Baseline and post-intervention (week 4)
Number of Trigger points
Count of active and latent trigger points in the upper trapezius muscle, assessed by palpation.
Measured: Measurements were taken pre- and post-intervention.(week 4)
Pain Pressure Threshold (Algometer)
Measured using a digital algometer (kg/cm²) at trigger point sites to assess pain sensitivity.
Measured: Measurements were taken pre- and post-intervention. (week 4)
Neck Function (CNFDS(Copenhagen Neck Functional Disability)
Assessed using the Copenhagen Neck Functional Disability Scale, evaluating neck-related disability (0-30, higher scores indicate greater disability).
Measured: Measurements were taken pre- and post-intervention. (week 4)
WHO-5(World Health Organization-Five Well-Bing Index)
Description: Measured using the WHO-5 Well-Being Index, a 5-item scale (0-25, higher scores indicate better well-being)
Measured: Measurements were taken pre- and post-intervention. (week 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2025
- Study start15 Jan 2025
- Primary completion15 May 2025
- Study completion25 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Myofascial Pain SyndromeStudies 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
- This study employs a parallel assignment model with three distinct intervention arms. Ninety participants with trigger points in the upper trapezius muscle are randomly assigned to one of three groups (n=30 each): non-invasive vagus nerve stimulation (nVNS), ischemic compression (trigger point massage), or exercise (control). Each group receives their respective intervention over 10 sessions (3 times per week for 4 weeks). The parallel design ensures that participants remain in their assigned group throughout the study, with no crossover. Outcomes, including pain intensity, trigger point number, pain pressure threshold, neck function, well-being, and functional mobility, are assessed at baseline and post-intervention (week 4). Single blinding (outcomes assessor) is implemented to minimize bias in outcome measurements.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bahçeşehir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shahla Hassanilar Ansaroudi, Bahçeşehir University
- Investigators
- Hasankerem Alptekin, Prof.DR, Study director, Bahçeşehir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07045324
- Sponsor's protocol ID
- BAU-MA25
- Status last verified
- Oct 2026
- First submitted
- 4 Jun 2025
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: "No individual participant data (IPD) will be shared due to privacy and ethical considerations, in accordance with institutional policies."
Publications
Xu A, Huang Q, Rong J, Wu X, Deng M, Ji L. Effectiveness of ischemic compression on myofascial trigger points in relieving neck pain: A systematic review and meta-analysis. J Back Musculoskelet Rehabil. 2023;36(4):783-798. doi: 10.3233/BMR-220045.
PubMed 36872769Moraska AF, Schmiege SJ, Mann JD, Butryn N, Krutsch JP. Responsiveness of Myofascial Trigger Points to Single and Multiple Trigger Point Release Massages: A Randomized, Placebo Controlled Trial. Am J Phys Med Rehabil. 2017 Sep;96(9):639-645. doi: 10.1097/PHM.0000000000000728.
PubMed 28248690Alghadir AH, Iqbal A, Anwer S, Iqbal ZA, Ahmed H. Efficacy of Combination Therapies on Neck Pain and Muscle Tenderness in Male Patients with Upper Trapezius Active Myofascial Trigger Points. Biomed Res Int. 2020 Mar 10;2020:9361405. doi: 10.1155/2020/9361405. eCollection 2020.
PubMed 32258159
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study on the Effect of Vagus Nerve Stimulation and Ischemic Compression on Trapezius Trigger Points
- ClinicalTrials.gov ID
- NCT07045324
- Acronym / sponsor ID
- BAU-MA25
- Conditions
- Myofascial Pain Syndrome, Trigger Points
- Keywords
- Trigger points, Vagus Nerve Stimulation, Parasympathetic System
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Bahçeşehir UniversityUniversity, hospital or other
- Study start
- 15 Jan 2025 (actual)
- Primary completion
- 15 May 2025 (actual)
- Study completion
- 25 Jun 2025 (actual)
- First posted
- 1 Jul 2025 (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 randomized controlled trial aimed to evaluate the efficacy of non-invasive vagus nerve stimulation (nVNS) compared to ischemic compression (trigger point massage) and exercise in treating trigger points in the upper trapezius muscle. Ninety participants aged 18-55 with at least two trigger points were randomly assigned to three groups: nVNS, ischemic compression, or exercise (control). Interventions were administered over 10 sessions (3 times per week). Outcomes included pain intensity (Visual Analog Scale, VAS), trigger point number, pain pressure threshold (algometer), neck function (Copenhagen Neck Functional Disability Scale, KBFÖS), well-being (WHO-5 Well-Being Index), and functional mobility. The nVNS group demonstrated statistically significant improvements in all outcomes compared to the other groups (p < 0.05).
Detailed description
Myofascial pain syndrome (MPS) is characterized by trigger points-hyperirritable spots in skeletal muscle associated with pain, stiffness, and reduced function. The upper trapezius muscle is a common site for trigger points, contributing to neck pain and disability. Traditional treatments include ischemic compression and exercise, but non-invasive vagus nerve stimulation (nVNS) has emerged as a promising modality due to its ability to modulate pain pathways and autonomic function.
This study investigated whether nVNS is more effective than ischemic compression or exercise in reducing pain and improving function in patients with trapezius trigger points. Participants were randomized into three groups (n=30 each)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- This study employs a parallel assignment model with three distinct intervention arms. Ninety participants with trigger points in the upper trapezius muscle are randomly assigned to one of three groups (n=30 each): non-invasive vagus nerve stimulation (nVNS), ischemic compression (trigger point massage), or exercise (control). Each group receives their respective intervention over 10 sessions (3 times per week for 4 weeks). The parallel design ensures that participants remain in their assigned group throughout the study, with no crossover. Outcomes, including pain intensity, trigger point number, pain pressure threshold, neck function, well-being, and functional mobility, are assessed at baseline and post-intervention (week 4). Single blinding (outcomes assessor) is implemented to minimize bias in outcome measurements.
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Vagus Nerve Stimulation (nVNS) | Experimental | Device: Vagus Nerve Stimulation (nVNS)Participants receive non-invasive auricular vagus nerve stimulation bilaterally to the concha and tragus using a TENS-based device (10 Hz, 300 µs, 20 minutes per session) for 10 sessions over 4 weeks, with intensity adjusted to patient comfort. |
| Arm 2: Ischemic Compression | Active comparator | Procedure: Ischemic CompressionParticipants receive manual trigger point massage (ischemic compression) applied to trapezius trigger points for 30-90 seconds per point, 3 times per week for 10 sessions. |
| Exercise (Control) | Active comparator | Behavioral: Exercise (Control)Participants perform a standardized exercise program including isometric neck exercises, upper trapezius stretching, and chin tuck exercises, conducted 3 times per week for 10 sessions. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age 18-55 years.
- Presence of at least two trigger points (active or latent) in the upper trapezius muscle, confirmed by palpation.
- Ability to provide informed consent.
Key exclusion criteria (6 listed)
- History of cervical spine surgery or trauma.
- Neurological disorders (e.g., epilepsy, stroke).
- Pregnancy or breastfeeding.
- Use of pacemakers or other implanted electrical devices.
- Active infection or skin lesions at the stimulation site.
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 Stimulation (nVNS)Arm 1 (Vagus Nerve Stimulation (nVNS)) is an experimental intervention, as it tests a novel approach (non-invasive vagus nerve stimulation) for trigger point treatment. | Device | Arm 1: Vagus Nerve Stimulation (nVNS) |
| Ischemic CompressionArm 2 (Ischemic Compression) is an active comparator, as it uses a standard treatment (trigger point massage) commonly applied for myofascial pain. | Procedure or surgery | Arm 2: Ischemic Compression |
| Exercise (Control)Arm 3 (Exercise (Control)) is explicitly labeled as the control group in your document, using a standard exercise program, which aligns with an active comparator (since it's an active intervention rather than a placebo or no intervention). | Behavioural | Exercise (Control) |
Primary outcome
Pain Intensity (VAS)(Visual Analog Scale )
Time frame: Baseline and post-intervention (week 4)
Measured using the Visual Analog Scale (0-10 ), where 0 indicates no pain and 10 indicates worst possible pain.
Number of Trigger points
Time frame: Measurements were taken pre- and post-intervention.(week 4)
Count of active and latent trigger points in the upper trapezius muscle, assessed by palpation.
Pain Pressure Threshold (Algometer)
Time frame: Measurements were taken pre- and post-intervention. (week 4)
Measured using a digital algometer (kg/cm²) at trigger point sites to assess pain sensitivity.
Neck Function (CNFDS(Copenhagen Neck Functional Disability)
Time frame: Measurements were taken pre- and post-intervention. (week 4)
Assessed using the Copenhagen Neck Functional Disability Scale, evaluating neck-related disability (0-30, higher scores indicate greater disability).
WHO-5(World Health Organization-Five Well-Bing Index)
Time frame: Measurements were taken pre- and post-intervention. (week 4)
Description: Measured using the WHO-5 Well-Being Index, a 5-item scale (0-25, higher scores indicate better well-being)
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 6 Oct 2026.
- Results publication: PubMed 36872769Xu A, Huang Q, Rong J, Wu X, Deng M, Ji L. Effectiveness of ischemic compression on myofascial trigger points in relieving neck pain: A systematic review and meta-analysis. J Back Musculoskelet Rehabil. 2023;36(4):783-798. doi: 10.3233/BMR-220045.
- Results publication: PubMed 28248690Moraska AF, Schmiege SJ, Mann JD, Butryn N, Krutsch JP. Responsiveness of Myofascial Trigger Points to Single and Multiple Trigger Point Release Massages: A Randomized, Placebo Controlled Trial. Am J Phys Med Rehabil. 2017 Sep;96(9):639-645. doi: 10.1097/PHM.0000000000000728.
- Results publication: PubMed 32258159Alghadir AH, Iqbal A, Anwer S, Iqbal ZA, Ahmed H. Efficacy of Combination Therapies on Neck Pain and Muscle Tenderness in Male Patients with Upper Trapezius Active Myofascial Trigger Points. Biomed Res Int. 2020 Mar 10;2020:9361405. doi: 10.1155/2020/9361405. eCollection 2020.
- Individual participant dataSharing planned: No. "No individual participant data (IPD) will be shared due to privacy and ethical considerations, in accordance with institutional policies."
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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.
Hasankerem Alptekin, Prof.DR study director
Bahçeşehir University
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 (nVNS) and Ischemic Compression in people with Myofascial Pain Syndrome and Trigger Points, run by Bahçeşehir 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 6 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 6 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?
Pain Intensity (VAS)(Visual Analog Scale ) (time frame: Baseline and post-intervention (week 4)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07045324, which also lists 3 linked publications.
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 Oct 2026.