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

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ClinicalTrials.gov Identifier: NCT02956863
Recruitment Status : Completed
First Posted : November 6, 2016
Last Update Posted : February 22, 2018
Sponsor:
Information provided by (Responsible Party):
Sandro Groisman, PT, DO, MSc, Instituto Brasileiro de Osteopatia

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Neck Pain Procedure: Osteopathic manipulative treatment Procedure: Exercises Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Osteopathic Manipulative Treatment in Pain and Functionality Individuals With Nonspecific Chronic Neck Pain: Randomized Clinical Trial
Actual Study Start Date : December 2016
Actual Primary Completion Date : July 2017
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Exercises
Individuals with neck pain will receive a exercises program. Participants will receive treatments during 4 weeks, 1 treatments per week.
Procedure: Exercises
Exercise for stretching and strength for neck muscles

Experimental: Osteopathic manipulative treatment
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
Osteopathic manipulative treatment delivered on pragmatic way.




Primary Outcome Measures :
  1. Pain intensity [ Time Frame: 30 days after end treatment ]
    measured by numeric rating scale


Secondary Outcome Measures :
  1. range of motion [ Time Frame: 30 days after end treatment ]
    measured by CROM device

  2. Pressure pain threshold [ Time Frame: 30 days after end treatment ]
    measured by electronic algometer

  3. functionality and disability [ Time Frame: 30 days after end treatment ]
    measured by Neck Disability Scale



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02956863


Locations
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Brazil
Sandro Groisman
Porto Alegre, RS, Brazil, 90130061
Sponsors and Collaborators
Instituto Brasileiro de Osteopatia
Investigators
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Principal Investigator: Sandro Groisman, MS IBO Brazilian Osteopathic Institute
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Responsible Party: Sandro Groisman, PT, DO, MSc, DO Ms, Instituto Brasileiro de Osteopatia
ClinicalTrials.gov Identifier: NCT02956863    
Other Study ID Numbers: 002
First Posted: November 6, 2016    Key Record Dates
Last Update Posted: February 22, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Neck Pain
Pain
Neurologic Manifestations