Cardiovascular Response to Two Manual Techniques for Neck Pain

Neck Pain Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02198677
• Other study ID #: AP vs LAT
• Status: Recruiting
• Phase: N/A
• First received: July 15, 2014
• Last updated: January 5, 2016
• Start date: July 2014
• Est. completion date: July 2016

Study information

• Verified date: January 2016
• Source: Azusa Pacific University
• Contact: Michael Wong, DPT
• Phone: 909 379 5433
• Email: mswong[@]apu.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 34
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neck Pain

Intervention

Procedure:
• Anterior to posterior pressures
Anterior to posterior pressures
• Lateral glide
Lateral glide

Locations

Country	Name	City	State
United States	Physical Therapy Department	Azusa	California

Sponsors (1)

Lead Sponsor	Collaborator
Azusa Pacific University

Country where clinical trial is conducted

United States, 

References & Publications (12)

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. Ep — View 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. Epub 2008 Sep 1. Erratum in: J Orthop Sports Phys Ther. 2009 Apr;39(4):297. — View 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.

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. — View 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. — View 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. — View Citation

Landis JR, Koch GG. The measurement of observer agreement for categorical data. Biometrics. 1977 Mar;33(1):159-74. — View Citation

Lidegaard Ø, Løkkegaard 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. — View Citation

Lidegaard Ø, Nielsen LH, Skovlund CW, Skjeldestad FE, Løkkegaard 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 — View 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. — View Citation

Puentedura EJ, Cleland JA, Landers MR, Mintken PE, Louw A, Fernández-de-Las-Peñas 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 — View 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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in heart rate		7 minutes before, 5 minutes before, During first set, During fifth set, 2 minutes after time point 4, 4 minutes after time point 4	Yes
Secondary	Change in blood pressure		7 minutes before, 5 minutes before, During first set, During fifth set, 2 minutes after time point 4, 4 minutes after time point 4	Yes
Secondary	Change in Numeric Pain Rating Scale		Baseline and within 7 days after the intervention	Yes
Secondary	Change in Neck Disability Index		Baseline and 7 days after the intervention	Yes
Secondary	Global rating of change		Immediately after intervention	Yes