Ignite Creation Date:
2024-05-06 @ 3:04 AM
Last Modification Date:
2024-10-26 @ 11:28 AM
Study NCT ID:
NCT02198677
Status:
UNKNOWN
Last Update Posted:
2016-01-07
First Post:
2014-07-15
Brief Title:
Cardiovascular Response to Two Manual Techniques for Neck Pain
Sponsor:
Azusa Pacific University
Organization:
Azusa Pacific University
Study Overview
Official Title:
Randomized Trial of Cardiovascular Response to Two Manual Techniques Non-thrust Joint Manipulation of the Cervical Spine in Patients With Non-traumatic Mechanical Neck Pain
Status:
UNKNOWN
Status Verified Date:
2016-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of the investigators study is to investigate whether posteriorly directed AP pressures and laterally directed LAT glides cause blood pressure and heart rate elevation or lowering in patients with neck pain The answer will advance the investigators understanding of why manual therapy works
Detailed Description:
To be included in the study these subjects with unilateral non-traumatic non-chronic neck pain operationally defined as neck pain with mobility deficits lasting less than 3 months shall have numeric pain rating scale NPRS of between 0 and 5 out of 10 as the most painful neck movement even with passive scapular elevation neck disability index NDI of between 16 and 50 out of 100 resting systolic and diastolic blood pressure between 9060 and 13888 and resting heart rate between 60 and 90 Subjects are excluded if they are current smoker over 50 years of age has a history of fainting spells or loss of consciousness is on blood thinners is taking medications for or have a history of diabetes mellitus neurologic or cardiovascular disease has a history of spinal surgeries and has neck pain classified or associated with headache radiating pain and movement coordination impairments A convenience sample of subjects will be randomly allocated to 1 of 2 groups Both Group 1 AP and Group 2 LAT will receive posterior pressures and lateral glides respectively to one hypomobile segment Baseline NPRS and NDI will be collected at the initial visit Systolic blood pressure SBP and heart rate HR will be measured with a OMRON automatic monitor recording time points 1 5 minutes and 2 7 minutes after lying supine 3 during the 1st set 4 5th set of one of the glides 5 2 minutes after time point 4 and 6 4 minutes after time point 4 After time point 6 a global rating of change GROC will immediately be collected based on the most painful neck movement A finger pulse oximeter will be placed on the subjects index finger to constantly monitor their pulse rate for slowing heart rate or asystole The primary author will perform one of the techniques on all subjects After one visit a follow-up NPRS and NDI will be collected again
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None