Effects of Autonomic Nervous System Modulation on Heart Rate Variability and Musculoskeletal Manifestations in Patients With Chronic Neck Pain
Unknown statusNot applicableNCT05922059
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
Background: Chronic neck pain is a widespread musculoskeletal disorder. Studies investigating the effect of autonomic nervous system (ANS) modulation in chronic neck pain are scarce. This study aims to examine the effects of ANS modulation on heart rate variability, pain, and function in patients with chronic neck pain. Methods: The intended study is a double-blind, randomized controlled trial in a parallel three arms fashion. Hundred and two patients with chronic neck pain will be recruited from King Fahd Hospital of the University in Alkhobar, Saudi Arabia. The patients will be randomly allocated equally into one of three groups. Group A (n = 34) will receive transcutaneous vagus nerve stimulation (tVNS) and standard-care physiotherapy (SC-PT). Group B (n = 34) will receive heart rate variability biofeedback (HRV-BF) and SC-PT. Group C (n = 34) will receive SC-PT alone. Each group will receive the intervention three times per week for six weeks. The primary outcome measures are HRV to assess ANS and the visual analog scale for pain intensity. The secondary outcome measures are pressure pain threshold and neck disability index. All these measures will be assessed on three occasions; at baseline, after three weeks, and after six weeks from baseline. For the statistical analysis, normality of the data will be performed prior to the analyses and suitable statistical tests will be applied to examine the effect of the interventions between the groups. The significance level sets at P \< 0.05.
Study details
- Official title
- Effects of Autonomic Nervous System Modulation on Heart Rate Variability and Musculoskeletal Manifestations in Patients With Chronic Neck Pain
- Conditions
- Autonomic Nervous System Modulation
- Interventions
- Device: Transcutaneous vagus nerve stimulation
- Device: Heart rate variability biofeedback
- Other: Standard-care physiotherapy
- Sponsor
- Imam Abdulrahman Bin Faisal University
- Start date
- 2023-07-18
- Primary completion
- 2023-10-30
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Total sites listed
- 0
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * adult aged ≥ 18 years old * have had neck pain for three months or more * reported peak neck pain of more than three on visual analogue scale (VAS) over the previous 24 hours Exclusion Criteria: * have had neck surgery * intra-articular corticosteroid injection within six months * current or past (within four weeks) oral corticosteroid use * neurological conditions * altered sensation to pressure * pregnancy * exhibited cognitive difficulties * arm numbness or tingling * cardiac pacemaker or other implantable stimulators * cardiac arrhythmia * history of myocardial infarction * local auricular diseases * symptomatic orthostatic hypotension
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05922059