Trial · NCT07894588
Effects of Adding Vagal Neuromodulation to Manual Therapy in Women With Fibromyalgia
NCT07894588, Not applicable, Not yet recruiting, Hasan Kalyoncu University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effects of Adding Vagal Neuromodulation to Manual Therapy in Women With Fibromyalgia. Trials, record NCT07894588. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07894588
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effects of Adding Vagal Neuromodulation to Manual Therapy in Women With Fibromyalgia
- NCT number
- NCT07894588
- Status
- Not yet recruiting
- Phases
- Not applicable
- Enrollment
- 44 participants, estimated
- Lead sponsor
- Hasan Kalyoncu University
- Conditions
- Fibromyalgia (FM) OR Fibromyalgia Syndrome, Manuel Therapy, Chronic Widespread Pain, Autonomic Nervous System Dysfunction, taVNS
- Interventions
- Transcutaneous Auricular Vagus Nerve Stimulation (taVNS), Sham Transcutaneous Auricular Vagus Nerve Stimulation (Sham taVNS), Manual Therapy Program, Diaphragmatic Breathing and Stretching Exercises
- First posted
- 2026-10-26
- Last updated
- 2026-10-26
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Pressure Pain Threshold (PPT) | Baseline and 8 weeks (after the intervention period) | Pressure pain threshold will be measured with a manual pressure algometer at the 18 tender points defined in the ACR fibromyalgia criteria (bilateral occiput, low cervical, trapezius, supraspinatus, second rib, lateral epicondyle, gluteal, greater trochanter, and knee). Pressure will be applied perpendicular to the skin at a steady rate, and the participant will report the moment the pressure first becomes painful. The value at that moment will be recorded at each point. The total algometric score will be calculated as the sum of the values from all 18 points. Higher scores indicate a higher pain threshold (lower pain sensitivity), and an increase from baseline indicates improvement. Measurements will be performed under standardized conditions at baseline and after the 8-week intervention. |
| Secondary | Short-Form McGill Pain Questionnaire (SF-MPQ) | Baseline and 8 weeks | The SF-MPQ is a 15-item questionnaire assessing the sensory and affective dimensions of pain. Participants rate each descriptor on a 4-point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe). The total score ranges from 0 to 45. Higher scores indicate greater pain. The Turkish validated version will be used. |
| Secondary | Heart Rate Variability (HRV) | Baseline and 8 weeks | Autonomic nervous system function will be assessed objectively by heart rate variability. R-R intervals will be recorded with a Polar H10 chest strap and analyzed with Kubios HRV Scientific Lite software. Time-domain parameters (e.g., RMSSD, SDNN) and frequency-domain parameters (e.g., LF, HF, LF/HF ratio) will be calculated in line with the Task Force standards. Higher RMSSD and HF values indicate greater parasympathetic (vagal) activity. |
| Secondary | Brief Illness Perception Questionnaire (Brief IPQ) | Baseline and 8 weeks | The Brief IPQ assesses the participant's cognitive and emotional representation of her illness. Eight items (consequences, timeline, personal control, treatment control, identity, concern, coherence, emotional response) are rated from 0 to 10, and the ninth item is an open-ended question about perceived causes. The total score of the first eight items ranges from 0 to 80 (after reverse-scoring the control and coherence items). Higher scores indicate a more threatening perception of the illness. |
| Secondary | Revised Fibromyalgia Impact Questionnaire (FIQ-R) | Baseline and 8 weeks | The FIQ-R is a 21-item self-report questionnaire assessing the overall impact of fibromyalgia over the past 7 days. It has three domains: function (9 items), overall impact (2 items), and symptoms (10 items). The total score ranges from 0 to 100. Higher scores indicate a greater impact of the disease on daily life. The Turkish validated version will be used. |
| Secondary | Pittsburgh Sleep Quality Index (PSQI) | Baseline and 8 weeks | The PSQI assesses sleep quality and sleep disturbances over the past month. Seven components (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, daytime dysfunction) are each scored from 0 to 3. The global score ranges from 0 to 21. Higher scores indicate poorer sleep quality (a global score above 5 indicates poor sleep). |
| Secondary | State-Trait Anxiety Inventory (STAI) | Baseline and 8 weeks | The STAI consists of 40 items rated on a 4-point scale (1-4): 20 items assess state anxiety (how the person feels at the moment) and 20 items assess trait anxiety (how the person generally feels). After reverse-scoring the relevant items, each subscale score ranges from 20 to 80. Higher scores indicate higher anxiety. The Turkish validated version will be used. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers17
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07894588
GET https://conductscience.org/api/trials/v1/NCT07894588/registered