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

NCT04911608 | Completed

• 1 other identifier: 5210211
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Neck Pain

Outcome Measures

Primary Outcomes (1)

• Neck Disability Index

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

  change between baseline and 2 days

Secondary Outcomes (3)

• Numeric Pain Rating Scale

  change between baseline and 2 days

• Global Ratio of Change

  change between baseline and 2 days

• Salivary Biomarkers

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

Study Arms (3)

cervical manipulation

EXPERIMENTAL

The cervical spinal manipulation will consist of one session of a standard technique that will be performed by an experienced (\>10 years) doctor of physical therapy practitioner. The technique is described by Gibbons and Tehan as a high-velocity, mid-range, low amplitude force at the segment of pain and/or segmental restrcition. 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. This type of cervical manipulation procedure is described by Gibbons and Tehan as "Minimal Leverage Thrust" and it results in optimal patient comfort while receiving the treatment thus reducing post-treatment soreness/pain.

Other: cervical spinal manipulation

cervical mobilization

EXPERIMENTAL

The cervical spinal mobilization treatment will also consist of one session of a standard technique that will be performed by an experienced (\>10 years) doctor of physical therapy practitioner. For this procedure, the 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. The magnitude of a mobilization-or how hard the therapist pushes on the spine-is usually reported as the magnitude of force. For an oscillatory posterior-anterior (PA) mobilization technique, the maximum magnitude of applied force is usually reported as the mean of the force peaks that occur during a specified period.34 The cervical mobilization will consist of oscillations of 1Hz and magnitude forces of 30 Newtons (N) for 30 seconds, 90N for 120 seconds and 30N for 30 seconds at the localized segment.

Other: cervical spinal mobilization

postural correction education

NO INTERVENTION

Participants will be presented with a standardized educational short video regarding the importance of postural correction movements.

Interventions

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 manipulation

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.

cervical mobilization

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (1)

Loma Linda University

Loma Linda, California, 92350, United States

Location

MeSH Terms

Conditions

Neck Pain

Interventions

Manipulation, Spinal

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Physical Therapy Modalities; Therapeutics; Rehabilitation

Study Officials

• Everett Lohman, Dsc

  Loma Linda University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Dean for Graduate Academic & Research Affairs Professor

Study Record Dates

• First Submitted: May 28, 2021
• First Posted: June 3, 2021
• Study Start: June 17, 2021
• Primary Completion: January 10, 2023
• Study Completion: January 10, 2023
• Last Updated: January 20, 2023

Record last verified: 2023-01

Locations

US (1)