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NCT Number: NCT04911608

Neuroendocrine Changes in Cervical Spinal Manipulation and Mobilization Non-specific Mechanical Neck Pain

The aim for this graduate student research project is to determine if cervical spinal mobilization releases similar neuropeptides and endogenous hormones as compared to cervical spinal manipulation and a control group. We hypothesized that application of cervical manipulations would result in a neuroendocrine response (SNS- HPA axis). By measuring salivary cortisol, oxytocin and DHEA, it may be possible to provide important information regarding the mechanisms and associations of pain modulation, anti-inflammatory and tissue healing after a biomechanical event.

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Key information

Conditions

Neck Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Loma Linda University

Loma Linda, California, 92350, United States

About this study

  • Participants will be completing three standardized questionnaires: The Neck Disability Index (NDI), Numeric Pain Rate Scale (NPRS), and the Global Ration of Change (GROC). These self-rated questionnaires will be used to capture the patient's level of pain, assess disability, and to quantify patient's improvement or deterioration over time, usually to either determine the effect of an intervention or to chart the clinical course of a condition.
  • Participants will be providing four saliva samples: Collecting biomarkers in saliva requires reliable, accurate methods for proper storage and handling techniques with high-quality assays and validated testing protocols. For this study, salivary oxytocin, cortisol and dehydroepiandrosterone (DHEA) will be collected in the morning (between 8 am and 11 am) for each participant at preintervention (baseline), and 15, 30 and 60 minutes after intervention by using self-collection kits in accordance with the manufacturer's instructions for each biomarker (Salimetrics Inc).
  • Participants will be receiving skilled interventions: Participants will be randomly assigned by using a computer-generated randomized table of numbers created prior to the start of data collection to one of the following three groups: cervical manipulation group, cervical mobilization group, no-touch group which will be receiving postural education. Cervical Spinal Manipulation (CSM) and Cervical Spinal Mobilizations (CSMob) are common techniques utilized by healthcare professionals to treat neck pain, low back pain and its effectiveness to treat musculoskeletal pain.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • . Subjects will be healthy male and females between 18 to 60 years of age.
  • . Resting neck pain ≤ 30 days that is mechanical in nature without radiating pain below shoulder.
  • . Neck Disability Index ≥ 10/50.
  • . Negative Upper Cervical instability tests such as Sharper-Purser test, Alar ligament test and Transverse ligament test.

Exclusion criteria

  • . Cervical Arterial Dysfunctions.
  • . Serious medical conditions (CA, spinal cord injury).
  • . History of instability disorders (History of neck injury, surgery, fractures, osteoporosis, arthritis, ankylosing spondylitis).
  • . Neurological conditions (Nerve root compression, central nervous system involvement, myelopathy, fibromyalgia.
  • . Endocrine dysfunctions (Autoimmune-related diseases, adrenal gland pathology, systematic metabolic disorders).
  • . Pregnancy/Lactating/Postpartum.
  • . Pending legal action regarding their neck pain.

Treatment and study plan

cervical spinal manipulation

Other

High-velocity, mid-range, low amplitude force at the segment of pain and/or segmental restriction. The participant will lay comfortably in a supine position, the practitioner will then use his clinical discretion to select the most appropriate or symptomatic cervical motion segments and attempt to localize the manual thrust at those levels. A maximum of 2 attempts for each side of the cervical spine will be allowed regardless of the having achieved joint cavitation.

cervical spinal mobilization

Other

Participant will lay comfortably in a prone position, the practitioner will then use his clinical discretion to select the most appropriate or symptomatic cervical motion segments and attempt to localize the manual forces at those segments.

Primary outcomes

  1. Neck Disability Index

    Time frame: change between baseline and 2 days

    Survey used to assess self-rated disability in patients with neck pain.

Secondary outcomes

  1. Numeric Pain Rating Scale

    Time frame: change between baseline and 2 days

    The questionnaire is used to capture the patient's level of pain by using an 11-point scale, ranging from 0 (no pain) to 10 (worst pain imaginable).

  2. Global Ratio of Change

    Time frame: change between baseline and 2 days

    This is a 15-point scale to rate the patient's own perception of improved or deteriorated function.

  3. Salivary Biomarkers

    Time frame: change between baseline and 15, 30 and 60 minutes after intervention.

    Salivary oxytocin, cortisol and dehydroepiandrosterone (DHEA) will be collected for each participant.

Sponsors and collaborators

Lead sponsor

Loma Linda University

Other

Registry information

Official study title

Neuroendocrine Changes After Cervical Spinal Manipulation and Mobilization in Subjects With Non-specific Mechanical Neck Pain

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jun 3, 2021
Registry last updated
Jan 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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