Cardiovascular Response to Two Manual Techniques for Neck Pain

NCT ID: NCT02198677

Last Updated: 2016-01-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2016-07-31

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.

Conditions

Neck Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

AP

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

Group Type: EXPERIMENTAL

Anterior to posterior pressures

Intervention Type: PROCEDURE

Anterior to posterior pressures

Lateral glides

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

Group Type: EXPERIMENTAL

Lateral glide

Intervention Type: PROCEDURE

Lateral glide

Interventions

Anterior to posterior pressures

Anterior to posterior pressures

Intervention Type: PROCEDURE

Lateral glide

Lateral glide

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azusa Pacific University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Wong, DPT

Role: PRINCIPAL_INVESTIGATOR

Azusa Pacific University

Emmanuel Yung, DPT

Role: PRINCIPAL_INVESTIGATOR

Sacred Heart University

Locations

Physical Therapy Department

Azusa, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Michael Wong, DPT

Role: CONTACT

mswong@apu.edu

909 379 5433

Facility Contacts

Michael Wong, DPT

Role: primary

References

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Reference Type: RESULT

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Other Identifiers

AP vs LAT

Identifier Type: -

Identifier Source: org_study_id