Clinical trial NCT02198677: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Neck Pain
Lead sponsor: Azusa Pacific University
Sponsor class: OTHER
First posted: 2014-07-24
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in heart rate
timeFrame: 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:
measure: Change in blood pressure
timeFrame: 7 minutes before, 5 minutes before, During first set, During fifth set, 2 minutes after time point 4, 4 minutes after time point 4
measure: Change in Numeric Pain Rating Scale
timeFrame: Baseline and within 7 days after the intervention
measure: Change in Neck Disability Index
timeFrame: Baseline and 7 days after the intervention
measure: Global rating of change
timeFrame: Immediately after intervention
Other outcomes:
Locations:
city: Azusa
country: United States
facility: Physical Therapy Department
state: California
Study officials:
affiliation: Azusa Pacific University
name: Michael Wong, DPT
role: PRINCIPAL_INVESTIGATOR
affiliation: Sacred Heart University
name: Emmanuel Yung, DPT
role: PRINCIPAL_INVESTIGATOR
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