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Chiropractic Maintenance Care and Heart Rate VariabilityNCT05401903

Relationship Between Chiropractic Care and Autonomic Nervous System Regulation

A study testing Chiropractic Maintenance Care in people with Chiropractic Maintenance Care and Heart Rate Variability, run by Northeast College of Health Sciences at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The objective for this study is to explore the utility of biometric devices to measure changes in heart rate variability (HRV) during chiropractic maintenance care. The study will use WHOOP wearable technology to measure HRV. Read more about this study

Who is it for?
Ages 18 to 40 years, men onlyHealthy volunteers can take part
What is being tested?
Chiropractic Maintenance Care
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteUnited States
Study dates
1 Jun 2022to 31 May 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Males, Minimum age of 18 years and Maximum age of 40 years
  • Subjects with access to a smart phone for use with the WHOOP app to allow for data tracking throughout the study.
  • Subjects are willing to be randomized to either the experimental group, maintenance chiropractic care, or control group, no chiropractic care.
  • Subjects are willing to not participate in other complementary and alternative medicine (CAM) therapies during the study period.

Who cannot join

  • Females.
  • Any diagnosed medical condition.
  • Any prescription medication use.
  • Have a pacemaker or other internal electronic device.
  • Any acute musculoskeletal (MSK) injuries involving the back and upper and lower extremities (e.g., neck, mid-back, lower back, shoulder, elbow, wrist, hand, hip, knee, ankle, foot etc.).
  • Any chronic MSK injuries involving the back and upper and lower extremities, (e.g., neck, mid-back, lower back, shoulder, elbow, wrist, hand, hip, knee, ankle, foot etc.).
  • Any contraindications to receive high velocity-low amplitude (HVLA) chiropractic manipulations.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Jeanmarie R Burke

    Seneca Falls, New York, 13148

Other trials in United States

About this study

Official title: Measurement of Heart Rate Variability During Chiropractic Maintenance Care: Relationship Between Chiropractic Care and Autonomic Nervous System Regulation

The objective for this study is to explore the utility of biometric devices to measure changes in heart rate variability (HRV) during chiropractic maintenance care. The study will use WHOOP wearable technology to measure HRV. Chiropractic maintenance care refers to regular visits to manage recurrent musculoskeletal pain and dysfunction [1]. Beyond managing pain and dysfunction, regular chiropractic visits may also promote improvements in homeostatic regulation of internal physiological conditions, but the evidence-based is lacking for these effects [2]. The hypothesis of this study is that chiropractic maintenance care may lead to an increase in HRV as compared to a control group that do not receive chiropractic care.

  1. Eklund A, Jensen I, Lohela-Karlsson M, Hagberg J, Leboeuf-Yde C, Kongsted A, et al. The Nordic maintenance care program: Effectiveness of chiropractic maintenance care versus symptom-guided treatment for recurrent and persistent low back pain-a pragmatic randomized controlled trial. PLoS One. 2018;13:e0203029.
  2. Kovanur Sampath K, Mani R, Cotter JD, Tumilty S. Measureable changes in the neuro-endocrinal mechanism following spinal manipulation. Med Hypotheses. 2015;85:819-24.
Read the detailed description

The study design is a pragmatic feasibility trial comparing the effects of chiropractic maintenance care versus a control group, no chiropractic care, on heart rate variability (HRV) in healthy male adults. The subjects in both groups will be healthy controls as the purpose of the study is to determine beneficial effects, if any, of chiropractic maintenance care on physiological function as opposed to pain management. The theoretical framework suggests a potential role of chiropractic maintenance care in the prevention of segmental dysfunction in the spine and cascading neuro-endocrine responses to biomechanical stress of the spinal segments, hypomobility [1, 2].

Chiropractic maintenance care will be for a duration of 8 weeks with subjects scheduled for one visit per week. Control subjects will be asked to refrain from chiropractic care for 8 weeks. All subjects will be asked to maintain the current status of their lifestyle behaviors for the duration of the study period, e.g. do not change diet or exercise training schedules. Using the WHOOP wearable technology to record daily HRV, the primary outcome is the weekly average of HRV. There will be a baseline week of HRV recordings prior to starting the intervention phase of the study. An increase in HRV of at least 6.5% from baseline to 8 weeks without a concomitant change in the control group will provide preliminary insights on chiropractic maintenance care and regulation of autonomic nervous system functions. As this is a feasibility study to explore the utility of biometric devices to measure changes in HRV during chiropractic maintenance care, sample size is limited to 20 subjects.

The 20 subjects will be healthy male adults from 18 to 40 years old. Given the small sample size. females are being excluded to avoid any confounding effects of menstrual cycle on the measurement of HRV. The summary of the evidence to date indicates medium to large effects in fluctuations of HRV across the menstrual cycle [3]. The study design will include simple randomization of subjects into chiropractic maintenance care or control group. The intervention group will receive weekly chiropractic care, in the form of high velocity, low amplitude (HVLA) chiropractic adjustments delivered to restricted vertebrae of the cervical, thoracic and lumbar spinal segments. Motion palpation of the spine will be used to identify restricted vertebrae of the cervical, thoracic and lumbar spinal segments. Subjects in the intervention group who do not attend at least four (4) scheduled chiropractic visits will be withdrawn from the study. Subjects in the control group who receive more than two (2) chiropractic treatments (visits) will be withdrawn from the study. Subjects in either group who receive more than two (2) other complementary and alternative (CAM) therapies (visits) will be withdrawn from the study.

  1. Kovanur Sampath K, Mani R, Cotter JD, Tumilty S. Measureable changes in the neuro-endocrinal mechanism following spinal manipulation. Med Hypotheses. 2015;85:819-24.
  2. Sampath KK, Botnmark E, Mani R, Cotter JD, Katare R, Munasinghe PE, et al. Neuroendocrine response following a thoracic spinal manipulation in healthy men. J Orthop Sports Phys Ther. 2017;47:617-27.
  3. Schmalenberger KM, Eisenlohr-Moul TA, Würth L, Schneider E, Thayer JF, Ditzen B, et al. A systematic review and meta-analysis of within-person changes in cardiac vagal activity across the menstrual cycle: Implications for female health and future studies. J Clin Med. 2019;8.
Being tested
Chiropractic Maintenance Care
Keywords
chiropractic, autonomic nervous system, healthy subjects

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Chiropractic Maintenance CareOther

    Subjects will receive high-velocity, low amplitude (HVLA) chiropractic manipulations to areas of defined restriction in the upper cervical spine, thoracic spine, lumbar spine, and pelvis. The clinician will use motion palpation to determine spinal segments with joint restrictions. Subjects will schedule weekly chiropractic visits.

    The clinician will not use passive care modalities. The exclusions of passive modalities include heat and cold therapies, electric stimulation, massage, acupuncture, and cupping therapies. Subjects will be encouraged to maintain normal exercise activity levels throughout the study. The clinician will provide instructions on homecare exercises as needed to promote range of motion of spinal segments between chiropractic visits. A single clinician will deliver the HVLA chiropractic manipulations to ensure consistency of chiropractic care throughout the study.

Study groups in NCT05401903
Study groupRoleWhat they receive
Chiropractic Maintenance CareExperimentalThe intervention group will receive weekly chiropractic care, in the form of high-velocity, low amplitude (HVLA) chiropractic adjustments delivered to restricted vertebrae of the cervical, thoracic and lumbar spinal segments. The intervention duration is 8 weeks. Subjects in the intervention group who do not attend at least four (4) scheduled chiropractic visits will be withdrawn from the study.
Receives: Other: Chiropractic Maintenance Care
ControlNo interventionThe control group will not receive any chiropractic care during study protocol.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Heart Rate Variability

    Using the WHOOP wearable technology, daily Heart Rate Variability calculated during sleep will be recorded and averaged by week

    Measured: Nine Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jun 2022
  2. Study start1 Jun 2022
  3. Primary completion31 May 2023
  4. Study completion31 May 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Pragmatic feasibility trial comparing the effects of chiropractic maintenance care versus a control group, no chiropractic care, on heart rate variability in healthy male adults.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05401903
Sponsor's protocol ID
22-02
Status last verified
Nov 2023
First submitted
29 May 2022
Last updated
18 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Chiropractic Maintenance Care in people with Chiropractic Maintenance Care and Heart Rate Variability, run by Northeast College of Health Sciences at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Heart Rate Variability (time frame: Nine Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023; AzTrials last refreshed its copy on 6 Nov 2026.

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