Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03085355
Recruitment Status : Recruiting
First Posted : March 21, 2017
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 March 19, 2017
First Posted Date  ICMJE March 21, 2017
Last Update Posted Date February 22, 2018
Actual Study Start Date  ICMJE June 1, 2017
Estimated Primary Completion Date June 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 19, 2017)
Pain intensity [ Time Frame: Measured pre and post treatment, 4 weeks after treatment and 8 weeks after treatment ]
measured by numeric rating scale
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03085355 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 19, 2017)
  • Functionality and disability [ Time Frame: Measured pre and post treatment, 4 weeks after treatment and 8 weeks after treatment ]
    measured by Neck Disability Scale
  • Range of motion [ Time Frame: Measured pre and post treatment, 4 weeks after treatment and 8 weeks after treatment ]
    measured by CROM device
  • Pressure pain threshold [ Time Frame: Measured pre and post treatment, 4 weeks after treatment and 8 weeks after treatment ]
    measured by electronic algometer
  • Global perceived effect [ Time Frame: Measured pre and post treatment, 4 weeks after treatment and 8 weeks after treatment ]
    measured by global perceived rating scale
  • Self-efficacy [ Time Frame: Measured pre and post treatment, 4 weeks after treatment and 8 weeks after treatment ]
    measured by The Pain Self-Efficacy Questionnaire
  • Catastrophizing [ Time Frame: Measured pre and post treatment, 4 weeks after treatment and 8 weeks after treatment ]
    measure by pain catastrophizing scale
  • kinesiophobia [ Time Frame: Measured pre and post treatment, 4 weeks after treatment and 8 weeks after treatment ]
    measure by TAMPA scale
  • McGuill [ Time Frame: Measured pre and post treatment, 4 weeks after treatment and 8 weeks after treatment ]
    measure by Mcguill scale
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of the Effect of the OMT Exercises Education for Pain in Participants With Cervical Pain
Official Title  ICMJE 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
Brief Summary 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

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

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
  • Pain, Neck
Intervention  ICMJE
  • Procedure: Exercises and PNE
    Exercise for stretching and strength for neck muscles and pain neuroscience education
  • Procedure: Osteopathic manipulative treatment
    Osteopathic manipulative treatment associated exercise for stretching and strength for neck muscles and pain neuroscience education
Study Arms  ICMJE
  • Active Comparator: Exercises and PNE
    Individuals with neck pain will receive a exercises program and pain neuroscience education. Participants will receive treatments during 4 weeks, 1 treatment per week
    Intervention: Procedure: Exercises and PNE
  • Experimental: Osteopathic manipulative treatment
    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)
    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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 19, 2017)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 1, 2018
Estimated Primary Completion Date June 1, 2018   (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
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Sandro Groisman sandrogroisman@gmail.com
Contact: Luciano Silva lssfisio@gmail.com
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03085355
Other Study ID Numbers  ICMJE 003
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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 UFCSPA Federal University of Health Science of Porto Alegre
Study Director: Geraldo Jotz, Phd UFCSPA Federal University of Health Science of Porto Alegre
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