Effects of Autonomic Nervous System Modulation on Heart Rate Variability and Musculoskeletal Manifestations in Patients With Chronic Neck Pain

NCT ID: NCT05922059

Last Updated: 2023-07-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-18
• Study Completion Date: 2023-12-31

Brief Summary

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.

Detailed Description

Sample size calculation was performed using statistical software (G*Power 3.1). The effect size (ES) of HRV was obtained from a previous study (Hallman et al., 2011). The following combination was used to calculate the sample size: analysis of variance (ANOVA), repeated measures, within-between interaction, ES of 0.15, an alpha level of 0.05, power (1-β) of 80%, correlation among repeated measure of 0.5, with three groups and three measurements (time points) and non-sphericity correction (Є) of 1. The estimated desired sample size was 93 patients. Three patients per group will be needed considering a 10% attrition rate. Thus, the total required sample size is 102 patients, 34 patients in each group.

The study will be conducted in the Department of Physiotherapy at KFHU Saudi Arabia. Patients with chronic neck pain who will attend KFHU and fit the inclusion criteria will be recruited consecutively and randomly allocated into Group A (transcutaneous vagus nerve stimulation + standard-care physiotherapy), Group B (HRV-BF + standard-care physiotherapy), or Group C (standard-care physiotherapy alone). The randomization sequence will be computer-generated using the GraphPad website (http://www.graphpad.com/). Hundred and two patients will be uniquely randomized equally into three different groups; each number and its allocated group will be written on a piece of paper and concealed in an opaque envelope. A receptionist will inform the treating therapist about the patient's allocation later after the baseline measurements are performed.

An independent, a physiotherapist (assessor) from the Department of Physiotherapy (with > 10 years of clinical experience in physiotherapy) who is blinded to the allocation (treatment group) of the patients will collect the demographic data and baseline outcome measurements. Then, the assessor will leave the room to remain blind to conditions. At the same time, the treating physiotherapist, the main researcher, (with > 10 years of clinical experience in musculoskeletal physiotherapy) will apply the treatment protocol according to the patient's allocated group. The treating therapist will be blind to the outcome measurements until the patients end their role in the study. Patients will be asked not to discuss their treatment experience with the assessor. The assessor will perform the outcome measurements three weeks and six weeks after intervention.

Conditions

Autonomic Nervous System Modulation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Vagus nerve stimulation

Transcutaneous vagus nerve stimulation in addition to standard-care physiotherapy

Group Type: EXPERIMENTAL

Transcutaneous vagus nerve stimulation

Intervention Type: DEVICE

Auricular transcutaneous vagus nerve stimulation will be used in the left cavity of the external ear with a stimulation frequency of 20-30 Hz for half hour. Monophasic rectangular waveforms will be used, and the intensity will be adjusted below the patient's pain threshold.

Heart rate variability biofeedback

Heart rate variability biofeedback in addition to standard-care physiotherapy

Group Type: EXPERIMENTAL

Heart rate variability biofeedback

Intervention Type: DEVICE

The patient will receive visual HRV feedback during resonance frequency breathing. Finally, the patient will be instructed to maximize their peak-to-peak HRV and attain the phase between respiration and HRV changes as closely as possible

standard-care physiotherapy alone

standard-care physiotherapy

Group Type: ACTIVE_COMPARATOR

Standard-care physiotherapy

Intervention Type: OTHER

consists of cervical mobilization on the painful segment, isometric exercise for neck flexors, and a combination of strengthening and stretching exercises from sitting position; cervical extensors strengthening exercise using red color Thera-band and stretching exercises upper trapezius of the painful side.

Interventions

Transcutaneous vagus nerve stimulation

Auricular transcutaneous vagus nerve stimulation will be used in the left cavity of the external ear with a stimulation frequency of 20-30 Hz for half hour. Monophasic rectangular waveforms will be used, and the intensity will be adjusted below the patient's pain threshold.

Intervention Type: DEVICE

Heart rate variability biofeedback

The patient will receive visual HRV feedback during resonance frequency breathing. Finally, the patient will be instructed to maximize their peak-to-peak HRV and attain the phase between respiration and HRV changes as closely as possible

Intervention Type: DEVICE

Standard-care physiotherapy

consists of cervical mobilization on the painful segment, isometric exercise for neck flexors, and a combination of strengthening and stretching exercises from sitting position; cervical extensors strengthening exercise using red color Thera-band and stretching exercises upper trapezius of the painful side.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Imam Abdulrahman Bin Faisal University

OTHER

Sponsor Role: lead

Responsible Party

Hani Alkhawajah

Principal Investigator - Senior Physiotherapist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Hani A Alkhawajah, MSc

Role: CONTACT

hkhawajah@iau.edu.sa

0138966666 ext. 1074

Other Identifiers

IRB-PGS-2023-03-096

Identifier Type: -

Identifier Source: org_study_id