Evaluation of the Effect of the OMT Exercises Education for Pain in Participants With Cervical Pain

Study Overview
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Brief Summary
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The purpose of this randomized pragmatic clinical trial is to assess the effectiveness of the association of the osteopathic manipulative treatment in individuals with chronic non-specific neck pain who receive a exercice program and pain neurocience education.

Detailed Description
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The purpose of this study is to determine whether osteopathic manipulative treatment associated exercises and pain neurocience education improves pain and function in individuals with chronic non-specific neck pain Design: a randomized single blind controlled pragmatic trial will be conducted trial. Patients (n=40) with non-specific neck pain will be randomized to receive 1) osteopathic manipulative treatment and exercise and and pain neurocience education (n=20) or 2) exercise alone and pain neurocience education (n=20). Participants will receive 8 treatments during 4 weeks. Clinical outcomes will be obtained at 1 week, four weeks and 24 weeks after end of treatment. Methods: The primary outcome will be pain measured by 11-point numerical pain rating scale. The secondary outcome will be disability measured by the Neck Disability Index, range of motion measured by Cervical Range of Motion device, Pressure pain threshold measured by electronic algometer, global perceived effect, Pain Self-Efficacy Questionnaire and pain catastrophizing scale

Official Title
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Evaluation of the Effects of the Association of the Osteopathic Manipulative Treatment to Exercises, Education for Pain in Participants With Cervical Pain - Pragmatic Clinical Trial Randomized

Conditions
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Neck Pain, Pain, Neck

Intervention / Treatment
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* Procedure: Exercises and PNE
* Procedure: Osteopathic manipulative treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Symptoms of chronic neck pain does not specify that persists for more than 3 months Pain at least 3 points on 0-10 numeric pain rating and at least 14% disability on Neck Disability Index Exclusion Criteria: individuals who report inflammatory previous surgery, spondylolisthesis, spinal stenosis, herniated disc, radiculopathy, fracture and musculoskeletal degenerative diseases. , Cancer, neurological diseases, pregnancy. They will be excluded participants who received some form of manipulative treatment in the last three months.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 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 |
| --- | --- |
| Active Comparator: Exercises and PNE<br>Individuals with neck pain will receive a exercises program and pain neuroscience education. Participants will receive treatments during 4 weeks, 1 treatment per week | Procedure: Exercises and PNE<br>* Exercise for stretching and strength for neck muscles and pain neuroscience education<br>|
| Experimental: Osteopathic manipulative treatment<br>Individuals with neck pain in this group will also receive a exercises program and pain neuroscience education and the participants will receive treatments during 4 weeks, 1 treatment per week associated with Osteopathic Manipulative Treatment (OMT) | Procedure: Osteopathic manipulative treatment<br>* Osteopathic manipulative treatment associated exercise for stretching and strength for neck muscles and pain neuroscience education<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity | measured by numeric rating scale | Measured pre and post treatment, 4 weeks after treatment and 8 weeks after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functionality and disability | measured by Neck Disability Scale | Measured pre and post treatment, 4 weeks after treatment and 8 weeks after treatment | 
| Range of motion | measured by CROM device | Measured pre and post treatment, 4 weeks after treatment and 8 weeks after treatment | 
| Pressure pain threshold | measured by electronic algometer | Measured pre and post treatment, 4 weeks after treatment and 8 weeks after treatment | 
| Global perceived effect | measured by global perceived rating scale | Measured pre and post treatment, 4 weeks after treatment and 8 weeks after treatment | 
| Self-efficacy | measured by The Pain Self-Efficacy Questionnaire | Measured pre and post treatment, 4 weeks after treatment and 8 weeks after treatment | 
| Catastrophizing | measure by pain catastrophizing scale | Measured pre and post treatment, 4 weeks after treatment and 8 weeks after treatment | 
| kinesiophobia | measure by TAMPA scale | Measured pre and post treatment, 4 weeks after treatment and 8 weeks after treatment | 
| McGuill | measure by Mcguill scale | Measured pre and post treatment, 4 weeks after treatment and 8 weeks after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neck pain