NCT02198677

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

July 15, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 24, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

January 7, 2016

Status Verified

January 1, 2016

Enrollment Period

2 years

First QC Date

July 15, 2014

Last Update Submit

January 5, 2016

Conditions

Neck Pain

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (4)

  • 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

  • Change in Numeric Pain Rating Scale

    Baseline and within 7 days after the intervention

  • Change in Neck Disability Index

    Baseline and 7 days after the intervention

  • Global rating of change

    Immediately after intervention

Study Arms (2)

AP

EXPERIMENTAL

Anterior to posterior pressures 5x10 seconds per set with 10 seconds rest between each set

Procedure: Anterior to posterior pressures

Lateral glides

EXPERIMENTAL

Lateral glides 5x10 seconds per set with 10 seconds rest between each set

Procedure: Lateral glide

Interventions

Anterior to posterior pressuresPROCEDURE

Anterior to posterior pressures

AP
Lateral glidePROCEDURE

Lateral glide

Lateral glides

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Physical Therapy Department

Azusa, California, 91784, United States

RECRUITING

Related Publications (12)

  • 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.

    PMID: 18758050BACKGROUND

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

    PMID: 843571BACKGROUND

  • 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.

    PMID: 20122805RESULT

  • 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.

    PMID: 15990659RESULT

  • 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.

    PMID: 11208222RESULT

  • 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.

    PMID: 21595633RESULT

  • 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.

    PMID: 22693997RESULT

  • 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.

    PMID: 22027398RESULT

  • 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.

    PMID: 11440535RESULT

  • 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.

    PMID: 22585595RESULT

  • 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.

    PMID: 17885341RESULT

  • 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.

    RESULT

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Michael Wong, DPT

    Azusa Pacific University

    PRINCIPAL INVESTIGATOR

  • Emmanuel Yung, DPT

    Sacred Heart University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Wong, DPT

CONTACT

909 379 5433mswong@apu.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 15, 2014

First Posted

July 24, 2014

Study Start

July 1, 2014

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

January 7, 2016

Record last verified: 2016-01

Locations

US(1)