Auricular Vagus Nerve Stimulation and Manual Therapy to Reduce Pain and Improve Function in People with Neck Pain

Cranio-Cervicomyofascial Release and Auricular Vagus Nerve Stimulation for Pain, Autonomic Modulation, and Function in Mechanical Neck Pain: A Randomized Controlled Trial - NECK-RESET

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/08/093892

Enrollment

200

Registered

2025-08-29

Start date

Unknown

Completion date

Unknown

Last updated

2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: M953- Acquired deformity of neck

Interventions

Intervention1: Osteopathic Cranio-Cervicomyofascial Release (CCMR): Suboccipital release (bilateral), Cranial fascial release vault hold, frontalandtemporal decompression, sphenobasilar balance indire

Eligibility

Inclusion criteria

Inclusion criteria: 1. Mechanical neck pain with or without referred shoulder/upper-back pain more than 2 weeks, NPRS more than 3/10. 2. NDI more than 10/50. 3. Patient Able to attend 2 sessions per week for 4 weeks and follow home program.

Exclusion criteria

Exclusion criteria: The exclusion criteria were: radicular cervical syndrome; any kind of fracture or postoperative condition of the cervical spine; any utilization of medical intervention, physiotherapy intervention since past 4 weeks; history of whiplash injury; cervical radiculopathy.

Design outcomes

Primary

Measure	Time frame
Neck Disability Index (NDI, 0?50)Timepoint: 4 weeks and 8 weeks	—

Secondary

Measure	Time frame
1. Pain intensity: 11-point NPRS (current/avg last week). 2. Pain sensitivity: Pressure Pain Thresholds (PPT, kg/cm?) at: suboccipitals, upper trapezius, C5 paraspinals (bilateral); 3 trials/site. 3. Cervical ROM: flexion/extension, rotation, lateral flexion via inclinometer or CROM. 4. Posture: Craniovertebral angle (digital photogrammetry). 5. Autonomic modulation: HRV (5-min seated, ECG or validated HR monitor): time-domain RMSSD, freq-domain HF power (0.15?0.4 Hz), LF/HF. 6. Psychosocial: Pain Catastrophizing Scale (PCS), Tampa Kinesiophobia (TSK-11). 7. Sleep/Quality of life: PSQI, EQ-5D-5L. 8. Global Perceived Effect (GPE); Patient-Specific Functional Scale (PSFS). 9. Analgesic use (diary) and adverse events. Timepoint: 4 weeks and 8 weeks	—

Measure

Time frame

1. Pain intensity: 11-point NPRS (current/avg last week). 2. Pain sensitivity: Pressure Pain Thresholds (PPT, kg/cm?) at: suboccipitals, upper trapezius, C5 paraspinals (bilateral); 3 trials/site. 3. Cervical ROM: flexion/extension, rotation, lateral flexion via inclinometer or CROM. 4. Posture: Craniovertebral angle (digital photogrammetry). 5. Autonomic modulation: HRV (5-min seated, ECG or validated HR monitor): time-domain RMSSD, freq-domain HF power (0.15?0.4 Hz), LF/HF. 6. Psychosocial: Pain Catastrophizing Scale (PCS), Tampa Kinesiophobia (TSK-11). 7. Sleep/Quality of life: PSQI, EQ-5D-5L. 8. Global Perceived Effect (GPE); Patient-Specific Functional Scale (PSFS). 9. Analgesic use (diary) and adverse events. Timepoint: 4 weeks and 8 weeks

—

Countries

India

Contacts

Public ContactDr Ramesh

Lovely Professional University Faculty of Applied Medical Sciences

rameshpatra2208@gmail.com09653174563

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026