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

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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

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.

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

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : June 1, 2017
Estimated Primary Completion Date : June 1, 2018
Estimated Study Completion Date : December 1, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
Procedure: Exercises and PNE
Exercise for stretching and strength for neck muscles and pain neuroscience education

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)
Procedure: Osteopathic manipulative treatment
Osteopathic manipulative treatment associated exercise for stretching and strength for neck muscles and pain neuroscience education




Primary Outcome Measures :
  1. Pain intensity [ Time Frame: Measured pre and post treatment, 4 weeks after treatment and 8 weeks after treatment ]
    measured by numeric rating scale


Secondary Outcome Measures :
  1. Functionality and disability [ Time Frame: Measured pre and post treatment, 4 weeks after treatment and 8 weeks after treatment ]
    measured by Neck Disability Scale

  2. Range of motion [ Time Frame: Measured pre and post treatment, 4 weeks after treatment and 8 weeks after treatment ]
    measured by CROM device

  3. Pressure pain threshold [ Time Frame: Measured pre and post treatment, 4 weeks after treatment and 8 weeks after treatment ]
    measured by electronic algometer

  4. 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

  5. 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

  6. Catastrophizing [ Time Frame: Measured pre and post treatment, 4 weeks after treatment and 8 weeks after treatment ]
    measure by pain catastrophizing scale

  7. kinesiophobia [ Time Frame: Measured pre and post treatment, 4 weeks after treatment and 8 weeks after treatment ]
    measure by TAMPA scale

  8. McGuill [ Time Frame: Measured pre and post treatment, 4 weeks after treatment and 8 weeks after treatment ]
    measure by Mcguill scale



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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older 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
  • 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.

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): NCT03085355


Contacts
Contact: Sandro Groisman sandrogroisman@gmail.com
Contact: Luciano Silva lssfisio@gmail.com

Locations
Brazil
Sandro Groisman Recruiting
Porto Alegre, RS, Brazil, 90130061
Contact: sandro Groisman, Ms    5505132324660    sandrogroisman@gmail.com   
Sponsors and Collaborators
Instituto Brasileiro de Osteopatia
Investigators
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

Responsible Party: Sandro Groisman, PT, DO, MSc, Master, Instituto Brasileiro de Osteopatia
ClinicalTrials.gov Identifier: NCT03085355     History of Changes
Other Study ID Numbers: 003
First Posted: March 21, 2017    Key Record Dates
Last Update Posted: February 22, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sandro Groisman, PT, DO, MSc, Instituto Brasileiro de Osteopatia:
neck pain

Additional relevant MeSH terms:
Neck Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms