Cardiovascular Response to Two Manual Techniques for Neck Pain

Sponsor
Azusa Pacific University (Other)
Overall Status
Unknown status
CT.gov ID
NCT02198677
Collaborator
(none)
34
1
2
24
1.4

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Anterior to posterior pressures
  • Procedure: Lateral glide
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
34 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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 Start Date :
Jul 1, 2014
Anticipated Primary Completion Date :
Jul 1, 2016
Anticipated Study Completion Date :
Jul 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: AP

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

Procedure: Anterior to posterior pressures
Anterior to posterior pressures

Experimental: Lateral glides

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

Procedure: Lateral glide
Lateral glide

Outcome Measures

Primary Outcome Measures

  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 Outcome Measures

  1. 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]

  2. Change in Numeric Pain Rating Scale [Baseline and within 7 days after the intervention]

  3. Change in Neck Disability Index [Baseline and 7 days after the intervention]

  4. Global rating of change [Immediately after intervention]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Physical Therapy Department Azusa California United States 91784

Sponsors and Collaborators

  • Azusa Pacific University

Investigators

  • Principal Investigator: Michael Wong, DPT, Azusa Pacific University
  • Principal Investigator: Emmanuel Yung, DPT, Sacred Heart University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Azusa Pacific University
ClinicalTrials.gov Identifier:
NCT02198677
Other Study ID Numbers:
  • AP vs LAT
First Posted:
Jul 24, 2014
Last Update Posted:
Jan 7, 2016
Last Verified:
Jan 1, 2016
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 7, 2016