Neck PainNCT04911608
Neuroendocrine Changes in Cervical Spinal Manipulation and Mobilization Non-specific Mechanical Neck Pain
A study testing cervical spinal manipulation and cervical spinal mobilization in people with Neck Pain, run by Loma Linda University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Neck Pain
- What is being tested?
- cervical spinal manipulation and cervical spinal mobilization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jun 2021to 10 Jan 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- . 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.
Who cannot join
- . 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neuroendocrine Changes After Cervical Spinal Manipulation and Mobilization in Subjects With 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.
Read the 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.
- Conditions
- Neck Pain
- Being tested
- cervical spinal manipulation, cervical spinal mobilization
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cervical spinal manipulationOther
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 mobilizationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neck Disability Index
Survey used to assess self-rated disability in patients with neck pain.
Measured: change between baseline and 2 days
Secondary outcomes (3)
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).
Measured: change between baseline and 2 days
Global Ratio of Change
This is a 15-point scale to rate the patient's own perception of improved or deteriorated function.
Measured: change between baseline and 2 days
Salivary Biomarkers
Salivary oxytocin, cortisol and dehydroepiandrosterone (DHEA) will be collected for each participant.
Measured: change between baseline and 15, 30 and 60 minutes after intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2021
- Study start17 Jun 2021
- Primary completion10 Jan 2023
- Study completion10 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Everett Lohman, Loma Linda University
- Investigators
- Everett Lohman, Dsc, Principal investigator, Loma Linda University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04911608
- Sponsor's protocol ID
- 5210211
- Status last verified
- Jan 2023
- First submitted
- 28 May 2021
- Last updated
- 20 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroendocrine Changes After Cervical Spinal Manipulation and Mobilization in Subjects With Non-specific Mechanical Neck Pain
- ClinicalTrials.gov ID
- NCT04911608
- Acronym / sponsor ID
- 5210211
- Conditions
- Neck Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- 17 Jun 2021 (actual)
- Primary completion
- 10 Jan 2023 (actual)
- Study completion
- 10 Jan 2023 (actual)
- First posted
- 3 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| cervical manipulation | Experimental | Other: cervical spinal manipulationThe 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. |
| cervical mobilization | Experimental | Other: cervical spinal mobilizationThe 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. |
| postural correction education | No intervention | –Participants will be presented with a standardized educational short video regarding the importance of postural correction movements. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- . 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.
Key exclusion criteria (7 listed)
- . 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cervical spinal manipulationHigh-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. | Other | cervical manipulation |
| cervical spinal mobilizationParticipant 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. | Other | cervical mobilization |
Primary outcome
Neck Disability Index
Time frame: change between baseline and 2 days
Survey used to assess self-rated disability in patients with neck pain.
3 secondary outcomes
Numeric Pain Rating Scale
Time frame: change between baseline and 2 days
Global Ratio of Change
Time frame: change between baseline and 2 days
Salivary Biomarkers
Time frame: change between baseline and 15, 30 and 60 minutes after intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Everett Lohman, Dsc principal investigator
Loma Linda University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cervical spinal manipulation and cervical spinal mobilization in people with Neck Pain, run by Loma Linda University 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 20 Jan 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?
Neck Disability Index (time frame: change between baseline and 2 days). 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 20 Jan 2023.