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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

Tracking Information
First Submitted Date  ICMJE November 3, 2016
First Posted Date  ICMJE November 6, 2016
Last Update Posted Date February 22, 2018
Actual Study Start Date  ICMJE December 2016
Actual Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 3, 2016)
Pain intensity [ Time Frame: 30 days after end treatment ]
measured by numeric rating scale
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 4, 2016)
  • range of motion [ Time Frame: 30 days after end treatment ]
    measured by CROM device
  • Pressure pain threshold [ Time Frame: 30 days after end treatment ]
    measured by electronic algometer
  • functionality and disability [ Time Frame: 30 days after end treatment ]
    measured by Neck Disability Scale
Original Secondary Outcome Measures  ICMJE
 (submitted: November 3, 2016)
  • range of motion [ Time Frame: 30 days after end treatment ]
    measured by CROM device
  • Pressure pain threshold [ Time Frame: 30 days after end treatment ]
    measured by electronic algometer
  • functionality and disability [ Time Frame: 30 days after end treatment ]
    measured by NDI scale
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Osteopathic Treatment in Pain and Functionality Individuals With Chronic Neck Pain
Official Title  ICMJE The Effect of Osteopathic Manipulative Treatment in Pain and Functionality Individuals With Nonspecific Chronic Neck Pain: Randomized Clinical Trial
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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Neck Pain
Intervention  ICMJE
  • Procedure: Osteopathic manipulative treatment
    Osteopathic manipulative treatment delivered on pragmatic way.
  • Procedure: Exercises
    Exercise for stretching and strength for neck muscles
Study Arms  ICMJE
  • Active Comparator: Exercises
    Individuals with neck pain will receive a exercises program. Participants will receive treatments during 4 weeks, 1 treatments per week.
    Intervention: Procedure: Exercises
  • 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)
    Intervention: Procedure: Osteopathic manipulative treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 3, 2016)
40
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2017
Actual Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02956863
Other Study ID Numbers  ICMJE 002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Sandro Groisman, PT, DO, MSc, Instituto Brasileiro de Osteopatia
Study Sponsor  ICMJE Instituto Brasileiro de Osteopatia
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sandro Groisman, MS IBO Brazilian Osteopathic Institute
PRS Account Instituto Brasileiro de Osteopatia
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP