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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercises and PNE | Active Comparator | Individuals with neck pain will receive a exercises program and pain neuroscience education. Participants will receive treatments during 4 weeks, 1 treatment per week |
|
| Osteopathic manipulative treatment | Experimental | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercises and PNE | Procedure | Exercise for stretching and strength for neck muscles and pain neuroscience education |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| sandro Groisman | UFCSPA Federal University of Health Science of Porto Alegre | Principal Investigator |
| Geraldo Jotz, Phd | UFCSPA Federal University of Health Science of Porto Alegre | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sandro Groisman | Porto Alegre | Rio Grande do Sul | 90130061 | Brazil |
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| ID | Term |
|---|---|
| D019547 | Neck Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| D026301 | Manipulation, Osteopathic |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| Osteopathic manipulative treatment | Procedure | Osteopathic manipulative treatment associated exercise for stretching and strength for neck muscles and pain neuroscience education |
|
| 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 |
| D026201 | Musculoskeletal Manipulations |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |