Comparison of Two Spinal Manipulation Treatments in Patients With Chronic Mechanical Neck Pain

Study Overview
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Brief Summary
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There is enough evidence to suggest that the spinal manipulation of the upper cervical spine and cervicothoracic spine are effective in decreasing neck pain. Therefore, the purpose of this randomized controlled trial is to compare the effects of an isolated application of upper cervical spine thrust joint manipulation with the application of a full combination of cervical, cervico-thoracic and thoracic spine thrust joint manipulation on neck pain, disability and cervical range of motion in individuals with chronic mechanical neck pain.

Official Title
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A Comparative Study Between Cervicothoracic and Upper Cervical Spine Manipulation in Patients With Chronic Mechanical Neck Pain: a Randomized Controlled Trial

Conditions
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Neck Pain

Intervention / Treatment
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* Other: Spinal manipulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Symptom persistence for more than 12 weeks. Age from 18 to 55 years. Localized pain in the cervical spine. Symptoms are caused by cervical movement or sustained postures. Exclusion Criteria: Stage acute of symptoms. Any contraindication to cervical spinal manipulation (fracture, osteoporosis, joint infections or vertebrobasilar insufficiency). Patients with previous neck trauma or cervical spine surgery. Patients diagnosed with cervical radiculopathy. Patients diagnosed with fibromyalgia. Have been treated with manual therapy in the last 3 months. Receiving other treatment during the course of the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Upper cervical spine manipulation group<br>Spinal thrust joint manipulation on the atlantoaxial joint | Other: Spinal manipulation<br>* Application of upper cervical spine thrust joint manipulation or application of a full combination of cervical, cervico-thoracic and thoracic spine thrust joint manipulation.<br>|
| Active Comparator: Cervicothoracic spine manipulations group<br>Different spinal thrust joint manipulations on the thoracic spine (T6), mid-cervical spine (C3-C4) and cervicothoracic junction (C7-T1). | Other: Spinal manipulation<br>* Application of upper cervical spine thrust joint manipulation or application of a full combination of cervical, cervico-thoracic and thoracic spine thrust joint manipulation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in neck pain at rest: Numeric Pain Rating Scale (0-10) | Neck pain at rest. Measured with the Numeric Pain Rating Scale (0 = ''no pain'' and 10 = ''worst imaginable pain). | Baseline and 15 days post-treatment | 
| Change in neck pain in flexion: Numeric Pain Rating Scale (0-10) | Pain in the cervical flexion movement. Measured with the Numeric Pain Rating Scale (0 = ''no pain'' and 10 = ''worst imaginable pain). | Baseline and 15 days post-treatment | 
| Change in neck pain in extension: Numeric Pain Rating Scale (0-10) | Pain in the cervical extension movement. Measured with the Numeric Pain Rating Scale (0 = ''no pain'' and 10 = ''worst imaginable pain). | Baseline and 15 days post-treatment | 
| Change in neck pain in right lateral flexion: Numeric Pain Rating Scale (0-10) | Pain in the cervical right lateral flexion movement. Measured with the Numeric Pain Rating Scale (0 = ''no pain'' and 10 = ''worst imaginable pain). | Baseline and 15 days post-treatment | 
| Change in neck pain in left lateral flexion: Numeric Pain Rating Scale (0-10) | Pain in the cervical left lateral flexion movement. Measured with the Numeric Pain Rating Scale (0 = ''no pain'' and 10 = ''worst imaginable pain). | Baseline and 15 days post-treatment | 
| Change in neck pain in right rotation: Numeric Pain Rating Scale (0-10) | Pain in the cervical right rotation movement. Measured with the Numeric Pain Rating Scale (0 = ''no pain'' and 10 = ''worst imaginable pain). | Baseline and 15 days post-treatment | 
| Change in neck pain in left rotation: Numeric Pain Rating Scale (0-10) | Pain in the cervical left rotation movement. Measured with the Numeric Pain Rating Scale (0 = ''no pain'' and 10 = ''worst imaginable pain). | Baseline and 15 days post-treatment | 
| Change in neck disability: Neck Disability Index (0-50) | Neck disability is measured with Neck Disability Index (10 items). A higher score indicates greater disability. | Baseline and 15 days post-treatment | 
| Change in flexion movement: Cervical Range of Motion device | Range of cervical motion in flexion. Measured with a Cervical Range of Motion (CROM) device | Baseline and 15 days post-treatment | 
| Change in extension movement: Cervical Range of Motion device | Range of cervical motion in extension. Measured with a Cervical Range of Motion (CROM) device | Baseline and 15 days post-treatment | 
| Change in right lateral flexion movement: Cervical Range of Motion device | Range of cervical motion in right lateral flexion. Measured with a Cervical Range of Motion (CROM) device | Baseline and 15 days post-treatment | 
| Change in left lateral flexion movement: Cervical Range of Motion device | Range of cervical motion in left lateral flexion. Measured with a Cervical Range of Motion (CROM) device | Baseline and 15 days post-treatment | 
| Change in right rotation movement: Cervical Range of Motion device | Range of cervical motion in right rotation. Measured with a Cervical Range of Motion (CROM) device | Baseline and 15 days post-treatment | 
| Change in left rotation movement: Cervical Range of Motion device | Range of cervical motion in left rotation. Measured with a Cervical Range of Motion (CROM) device | Baseline and 15 days post-treatment |