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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).
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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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). | 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) | Measurements were taken pre- and post-intervention. (week 4) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hasankerem Alptekin, Prof.DR | Bahçeşehir University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bahçeşehir University, Physiotherapy and Rehabilitation | Istanbul | Helthy | 34353 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36872769 | Result | 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. | |
| 28248690 | Result | Moraska 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. |
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"No individual participant data (IPD) will be shared due to privacy and ethical considerations, in accordance with institutional policies."
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 15, 2025 | Jun 27, 2025 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D009209 | Myofascial Pain Syndromes |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D055536 | Vagus Nerve Stimulation |
| D019050 | Acupressure |
| D015444 | Exercise |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D064746 | Therapy, Soft Tissue |
| D026201 | Musculoskeletal Manipulations |
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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.
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This study employs single blinding, where the outcomes assessors are masked to the participants' group assignments. Participants are randomized into one of three groups (non-invasive vagus nerve stimulation, ischemic compression, or exercise), and the interventions are administered by unblinded study personnel. To minimize bias, assessors responsible for measuring outcomes, including pain intensity (Visual Analog Scale), number of trigger points, pain pressure threshold (algometer), neck function (Copenhagen Neck Functional Disability Scale), well-being (WHO-5 Well-Being Index), and functional mobility, are unaware of the intervention each participant receives. Participants and intervention providers are not blinded due to the nature of the interventions.
| Ischemic Compression | Procedure | Arm 2 (Ischemic Compression) is an active comparator, as it uses a standard treatment (trigger point massage) commonly applied for myofascial pain. |
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| Exercise (Control) | Behavioral | 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). |
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| 32258159 | Result | Alghadir 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. |
| D000529 | Complementary Therapies |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |