NCT05922059

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2023

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 8, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

June 28, 2023

Completed
20 days until next milestone

Study Start

First participant enrolled

July 18, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

July 19, 2023

Status Verified

July 1, 2023

Enrollment Period

3 months

First QC Date

June 8, 2023

Last Update Submit

July 18, 2023

Conditions

Autonomic Nervous System Modulation

Keywords

Vagus nerve stimulationNeck painHeart rate variabilityHeart rhythm coherence feedback

Outcome Measures

Primary Outcomes (6)

  • Heart-rate variability (HRV)

    the changes in the inter-beat intervals (IBIs) that will be used to quantify the amount of HRV observed during monitoring periods (\<1 min to \>24 h). In this study, the monitoring period will be five minutes

    Baseline

  • Heart-rate variability (HRV)

    the changes in the inter-beat intervals (IBIs) that will be used to quantify the amount of HRV observed during monitoring periods (\<1 min to \>24 h). In this study, the monitoring period will be five minutes

    Change from baseline HRV after 3 weeks

  • Heart-rate variability (HRV)

    the changes in the inter-beat intervals (IBIs) that will be used to quantify the amount of HRV observed during monitoring periods (\<1 min to \>24 h). In this study, the monitoring period will be five minutes

    Change from baseline HRV after 6 weeks

  • Visual analog scale (VAS)

    Current pain intensity will be measured using a 10-cm VAS with endpoints marked 'no pain' at 0 and 'worst pain imaginable at 10.

    Baseline

  • Visual analog scale (VAS)

    Current pain intensity will be measured using a 10-cm VAS with endpoints marked 'no pain' at 0 and 'worst pain imaginable at 10.

    Change from baseline VAS after 3 weeks

  • Visual analog scale (VAS)

    Current pain intensity will be measured using a 10-cm VAS with endpoints marked 'no pain' at 0 and 'worst pain imaginable at 10.

    Change from baseline VAS after 6 weeks

Secondary Outcomes (6)

  • Pressure pain threshold (PPT)

    Baseline

  • Pressure pain threshold (PPT)

    Change from baseline PPT after 3 weeks

  • Pressure pain threshold (PPT)

    Change from baseline PPT after 6 weeks

  • Neck Disability Index (NDI)

    Baseline

  • Neck Disability Index (NDI)

    Change from baseline NDI after 3 weeks

  • +1 more secondary outcomes

Study Arms (3)

Vagus nerve stimulation

EXPERIMENTAL

Transcutaneous vagus nerve stimulation in addition to standard-care physiotherapy

Device: Transcutaneous vagus nerve stimulation

Heart rate variability biofeedback

EXPERIMENTAL

Heart rate variability biofeedback in addition to standard-care physiotherapy

Device: Heart rate variability biofeedback

standard-care physiotherapy alone

ACTIVE COMPARATOR

standard-care physiotherapy

Other: Standard-care physiotherapy

Interventions

Transcutaneous vagus nerve stimulationDEVICE

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.

Vagus nerve stimulation
Heart rate variability biofeedbackDEVICE

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

Heart rate variability biofeedback
Standard-care physiotherapyOTHER

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.

standard-care physiotherapy alone

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Hani A Alkhawajah, MSc

CONTACT

0138966666hkhawajah@iau.edu.sa

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Group A (transcutaneous vagus nerve stimulation + standard-care physiotherapy), Group B (HRV-BF + standard-care physiotherapy), or Group C (standard-care physiotherapy alone).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator - Senior Physiotherapist

Study Record Dates

First Submitted

June 8, 2023

First Posted

June 28, 2023

Study Start

July 18, 2023

Primary Completion

October 30, 2023

Study Completion

December 31, 2023

Last Updated

July 19, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will share

The work will be published in peer review journal

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
When data collection finalized. A manuscript will be written for publication. The estimated time is 1 year. After publication in peer review journal, the data will remain in the journal in accordance to journal policy