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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04911608
Enrollment
36
Registered
2021-06-03
Start date
2021-06-17
Completion date
2023-01-10
Last updated
2023-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neck Pain

Brief summary

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.

Detailed description

* 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.

Interventions

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.

OTHERcervical spinal mobilization

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.

Sponsors

Loma Linda University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

1. . Subjects will be healthy male and females between 18 to 60 years of age. 2. . Resting neck pain ≤ 30 days that is mechanical in nature without radiating pain below shoulder. 3. . Neck Disability Index ≥ 10/50. 4. . Negative Upper Cervical instability tests such as Sharper-Purser test, Alar ligament test and Transverse ligament test.

Exclusion criteria

1. . Cervical Arterial Dysfunctions. 2. . Serious medical conditions (CA, spinal cord injury). 3. . History of instability disorders (History of neck injury, surgery, fractures, osteoporosis, arthritis, ankylosing spondylitis). 4. . Neurological conditions (Nerve root compression, central nervous system involvement, myelopathy, fibromyalgia. 5. . Endocrine dysfunctions (Autoimmune-related diseases, adrenal gland pathology, systematic metabolic disorders). 6. . Pregnancy/Lactating/Postpartum. 7. . Pending legal action regarding their neck pain.

Design outcomes

Primary

MeasureTime frameDescription
Neck Disability Indexchange between baseline and 2 daysSurvey used to assess self-rated disability in patients with neck pain.

Secondary

MeasureTime frameDescription
Numeric Pain Rating Scalechange between baseline and 2 daysThe 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).
Global Ratio of Changechange between baseline and 2 daysThis is a 15-point scale to rate the patient's own perception of improved or deteriorated function.
Salivary Biomarkerschange between baseline and 15, 30 and 60 minutes after intervention.Salivary oxytocin, cortisol and dehydroepiandrosterone (DHEA) will be collected for each participant.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026