Cardiovascular Response to Two Manual Techniques for Neck Pain
Primary Purpose
Neck Pain
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Anterior to posterior pressures
Lateral glide
Sponsored by
About this trial
This is an interventional treatment trial for Neck Pain
Eligibility Criteria
Inclusion Criteria:
- Unilateral, non-traumatic, non-chronic mechanical neck pain
- Numeric pain rating scale between 0-5/10 as the most painful neck movement (with passive scapular elevation)
- Neck Disability Index between 16-50/100 percent
- Resting blood pressure between 90/60 and 138/88 mmHg
- Resting heart rate between 60 and 90 beats per minute
Exclusion Criteria:
- Current smoker
- Under 18 years and over 50 years of age
- History of fainting spells or loss of consciousness
- Currently on blood thinners
- Taking medications for or have a history of diabetes mellitus, neurologic or cardiovascular disease
- History of spinal surgery
- Has neck pain classified or associated headache, arm pain, trauma/whiplash
Sites / Locations
- Physical Therapy DepartmentRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
AP
Lateral glides
Arm Description
Anterior to posterior pressures 5x10 seconds per set with 10 seconds rest between each set
Lateral glides 5x10 seconds per set with 10 seconds rest between each set
Outcomes
Primary Outcome Measures
Change in heart rate
Secondary Outcome Measures
Change in blood pressure
Change in Numeric Pain Rating Scale
Change in Neck Disability Index
Global rating of change
Full Information
NCT ID
NCT02198677
First Posted
July 15, 2014
Last Updated
January 5, 2016
Sponsor
Azusa Pacific University
1. Study Identification
Unique Protocol Identification Number
NCT02198677
Brief Title
Cardiovascular Response to Two Manual Techniques for Neck Pain
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.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Unknown status
Study Start Date
July 2014 (undefined)
Primary Completion Date
July 2016 (Anticipated)
Study Completion Date
July 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Azusa Pacific University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 90/60 and 138/88, 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
34 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
AP
Arm Type
Experimental
Arm Description
Anterior to posterior pressures 5x10 seconds per set with 10 seconds rest between each set
Arm Title
Lateral glides
Arm Type
Experimental
Arm Description
Lateral glides 5x10 seconds per set with 10 seconds rest between each set
Intervention Type
Procedure
Intervention Name(s)
Anterior to posterior pressures
Intervention Description
Anterior to posterior pressures
Intervention Type
Procedure
Intervention Name(s)
Lateral glide
Intervention Description
Lateral glide
Primary Outcome Measure Information:
Title
Change in heart rate
Time Frame
7 minutes before, 5 minutes before, During first set, During fifth set, 2 minutes after time point 4, 4 minutes after time point 4
Secondary Outcome Measure Information:
Title
Change in blood pressure
Time Frame
7 minutes before, 5 minutes before, During first set, During fifth set, 2 minutes after time point 4, 4 minutes after time point 4
Title
Change in Numeric Pain Rating Scale
Time Frame
Baseline and within 7 days after the intervention
Title
Change in Neck Disability Index
Time Frame
Baseline and 7 days after the intervention
Title
Global rating of change
Time Frame
Immediately after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Unilateral, non-traumatic, non-chronic mechanical neck pain
Numeric pain rating scale between 0-5/10 as the most painful neck movement (with passive scapular elevation)
Neck Disability Index between 16-50/100 percent
Resting blood pressure between 90/60 and 138/88 mmHg
Resting heart rate between 60 and 90 beats per minute
Exclusion Criteria:
Current smoker
Under 18 years and over 50 years of age
History of fainting spells or loss of consciousness
Currently on blood thinners
Taking medications for or have a history of diabetes mellitus, neurologic or cardiovascular disease
History of spinal surgery
Has neck pain classified or associated headache, arm pain, trauma/whiplash
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Wong, DPT
Phone
909 379 5433
Email
mswong@apu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Wong, DPT
Organizational Affiliation
Azusa Pacific University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Emmanuel Yung, DPT
Organizational Affiliation
Sacred Heart University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Physical Therapy Department
City
Azusa
State/Province
California
ZIP/Postal Code
91784
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Wong, DPT
First Name & Middle Initial & Last Name & Degree
Michael Wong, DPT
12. IPD Sharing Statement
Citations:
PubMed Identifier
18758050
Citation
Childs JD, Cleland JA, Elliott JM, Teyhen DS, Wainner RS, Whitman JM, Sopky BJ, Godges JJ, Flynn TW; American Physical Therapy Association. Neck pain: Clinical practice guidelines linked to the International Classification of Functioning, Disability, and Health from the Orthopedic Section of the American Physical Therapy Association. J Orthop Sports Phys Ther. 2008 Sep;38(9):A1-A34. doi: 10.2519/jospt.2008.0303. Epub 2008 Sep 1. Erratum In: J Orthop Sports Phys Ther. 2009 Apr;39(4):297.
Results Reference
background
PubMed Identifier
843571
Citation
Landis JR, Koch GG. The measurement of observer agreement for categorical data. Biometrics. 1977 Mar;33(1):159-74.
Results Reference
background
PubMed Identifier
20122805
Citation
Bruehl S, Dengler-Crish CM, Smith CA, Walker LS. Hypoalgesia related to elevated resting blood pressure is absent in adolescents and young adults with a history of functional abdominal pain. Pain. 2010 Apr;149(1):57-63. doi: 10.1016/j.pain.2010.01.009. Epub 2010 Feb 1.
Results Reference
result
PubMed Identifier
15990659
Citation
Hurwitz EL, Morgenstern H, Vassilaki M, Chiang LM. Frequency and clinical predictors of adverse reactions to chiropractic care in the UCLA neck pain study. Spine (Phila Pa 1976). 2005 Jul 1;30(13):1477-84. doi: 10.1097/01.brs.0000167821.39373.c1.
Results Reference
result
PubMed Identifier
11208222
Citation
Knutson GA. Significant changes in systolic blood pressure post vectored upper cervical adjustment vs resting control groups: a possible effect of the cervicosympathetic and/or pressor reflex. J Manipulative Physiol Ther. 2001 Feb;24(2):101-9. doi: 10.1067/mmt.2001.112564.
Results Reference
result
PubMed Identifier
21595633
Citation
Krediet CT, Jardine DL, Wieling W. Dissection of carotid sinus hypersensitivity: the timing of vagal and vasodepressor effects and the effect of body position. Clin Sci (Lond). 2011 Nov;121(9):389-96. doi: 10.1042/CS20100607.
Results Reference
result
PubMed Identifier
22693997
Citation
Lidegaard O, Lokkegaard E, Jensen A, Skovlund CW, Keiding N. Thrombotic stroke and myocardial infarction with hormonal contraception. N Engl J Med. 2012 Jun 14;366(24):2257-66. doi: 10.1056/NEJMoa1111840.
Results Reference
result
PubMed Identifier
22027398
Citation
Lidegaard O, Nielsen LH, Skovlund CW, Skjeldestad FE, Lokkegaard E. Risk of venous thromboembolism from use of oral contraceptives containing different progestogens and oestrogen doses: Danish cohort study, 2001-9. BMJ. 2011 Oct 25;343:d6423. doi: 10.1136/bmj.d6423.
Results Reference
result
PubMed Identifier
11440535
Citation
McGuiness J, Vicenzino B, Wright A. Influence of a cervical mobilization technique on respiratory and cardiovascular function. Man Ther. 1997 Nov;2(4):216-220. doi: 10.1054/math.1997.0302.
Results Reference
result
PubMed Identifier
22585595
Citation
Puentedura EJ, Cleland JA, Landers MR, Mintken PE, Louw A, Fernandez-de-Las-Penas C. Development of a clinical prediction rule to identify patients with neck pain likely to benefit from thrust joint manipulation to the cervical spine. J Orthop Sports Phys Ther. 2012 Jul;42(7):577-92. doi: 10.2519/jospt.2012.4243. Epub 2012 May 14.
Results Reference
result
PubMed Identifier
17885341
Citation
Van Dillen LR, McDonnell MK, Susco TM, Sahrmann SA. The immediate effect of passive scapular elevation on symptoms with active neck rotation in patients with neck pain. Clin J Pain. 2007 Oct;23(8):641-7. doi: 10.1097/AJP.0b013e318125c5b6.
Results Reference
result
Citation
Egwu MO. Relative therapeutic efficacy of some vertebral mobilization techniques in the management of unilateral cervical spondylosis: a comparative study. Journal of Physical Therapy and Science. 2008;20:103-8.
Results Reference
result
Learn more about this trial
Cardiovascular Response to Two Manual Techniques for Neck Pain
We'll reach out to this number within 24 hrs