Neck Pain Clinical Trial
Official title:
Neuroendocrine Changes After Cervical Spinal Manipulation and Mobilization in Subjects With Non-specific Mechanical Neck Pain
NCT number | NCT04911608 |
Other study ID # | 5210211 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 17, 2021 |
Est. completion date | January 10, 2023 |
Verified date | January 2023 |
Source | Loma Linda University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 36 |
Est. completion date | January 10, 2023 |
Est. primary completion date | January 10, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Loma Linda University | Loma Linda | California |
Lead Sponsor | Collaborator |
---|---|
Loma Linda University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Neck Disability Index | Survey used to assess self-rated disability in patients with neck pain. | change between baseline and 2 days | |
Secondary | Numeric Pain Rating Scale | 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). | change between baseline and 2 days | |
Secondary | Global Ratio of Change | This is a 15-point scale to rate the patient's own perception of improved or deteriorated function. | change between baseline and 2 days | |
Secondary | Salivary Biomarkers | Salivary oxytocin, cortisol and dehydroepiandrosterone (DHEA) will be collected for each participant. | change between baseline and 15, 30 and 60 minutes after intervention. |
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