The Effect of Osteopathic Treatment in Pain and Functionality Individuals With Chronic Neck Pain

Study Overview
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Brief Summary
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The purpose of this study is to determine whether manipulative osteopathic treatment associated exercises improves pain and function in individuals with chronic non-specific neck pain

Detailed Description
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The purpose of this study is to determine whether manipulative osteopathic treatment associated exercises improves pain and function in individuals with chronic non-specific neck pain Design: a randomized single blind placebo controlled trial will be conducted trial. Patients (n=40) with non-specific neck pain will be randomized to receive 1) osteopathic manipulative treatment and exercise (n=20) or 2) exercise alone (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.

Official Title
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The Effect of Osteopathic Manipulative Treatment in Pain and Functionality Individuals With Nonspecific Chronic Neck Pain: Randomized Clinical Trial

Conditions
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Neck Pain

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


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 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: 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 |
| --- | --- |
| Active Comparator: Exercises<br>Individuals with neck pain will receive a exercises program. Participants will receive treatments during 4 weeks, 1 treatments per week. | Procedure: Exercises<br>* Exercise for stretching and strength for neck muscles<br>|
| Experimental: Osteopathic manipulative treatment<br>Individuals with neck pain in this group will also receive a exercises program and the participants will receive treatments during 4 weeks, 1 treatments per week associated with Osteopathic Manipulative Treatment (OMT) | Procedure: Osteopathic manipulative treatment<br>* Osteopathic manipulative treatment delivered on pragmatic way.<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 | 30 days after end treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| range of motion | measured by CROM device | 30 days after end treatment | 
| Pressure pain threshold | measured by electronic algometer | 30 days after end treatment | 
| functionality and disability | measured by Neck Disability Scale | 30 days after end treatment |