Evaluation of the Effect of the OMT Exercises Education for Pain in Participants With Cervical Pain
Primary Purpose
Neck Pain, Pain, Neck
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Exercises and PNE
Osteopathic manipulative treatment
Sponsored by
About this trial
This is an interventional treatment trial for Neck Pain focused on measuring neck pain
Eligibility 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.
Sites / Locations
- Sandro Groisman
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Exercises and PNE
Osteopathic manipulative treatment
Arm Description
Individuals with neck pain will receive a exercises program and pain neuroscience education. Participants will receive treatments during 4 weeks, 1 treatment per week
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)
Outcomes
Primary Outcome Measures
Pain intensity
measured by numeric rating scale
Secondary Outcome Measures
Functionality and disability
measured by Neck Disability Scale
Range of motion
measured by CROM device
Pressure pain threshold
measured by electronic algometer
Global perceived effect
measured by global perceived rating scale
Self-efficacy
measured by The Pain Self-Efficacy Questionnaire
Catastrophizing
measure by pain catastrophizing scale
kinesiophobia
measure by TAMPA scale
McGuill
measure by Mcguill scale
Full Information
NCT ID
NCT03085355
First Posted
March 19, 2017
Last Updated
November 2, 2019
Sponsor
Instituto Brasileiro de Osteopatia
1. Study Identification
Unique Protocol Identification Number
NCT03085355
Brief Title
Evaluation of the Effect of the OMT Exercises Education for Pain in Participants With Cervical Pain
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
June 1, 2018 (Actual)
Study Completion Date
December 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Brasileiro de Osteopatia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain, Pain, Neck
Keywords
neck pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exercises and PNE
Arm Type
Active Comparator
Arm Description
Individuals with neck pain will receive a exercises program and pain neuroscience education. Participants will receive treatments during 4 weeks, 1 treatment per week
Arm Title
Osteopathic manipulative treatment
Arm Type
Experimental
Arm Description
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 Type
Procedure
Intervention Name(s)
Exercises and PNE
Intervention Description
Exercise for stretching and strength for neck muscles and pain neuroscience education
Intervention Type
Procedure
Intervention Name(s)
Osteopathic manipulative treatment
Intervention Description
Osteopathic manipulative treatment associated exercise for stretching and strength for neck muscles and pain neuroscience education
Primary Outcome Measure Information:
Title
Pain intensity
Description
measured by numeric rating scale
Time Frame
Measured pre and post treatment, 4 weeks after treatment and 8 weeks after treatment
Secondary Outcome Measure Information:
Title
Functionality and disability
Description
measured by Neck Disability Scale
Time Frame
Measured pre and post treatment, 4 weeks after treatment and 8 weeks after treatment
Title
Range of motion
Description
measured by CROM device
Time Frame
Measured pre and post treatment, 4 weeks after treatment and 8 weeks after treatment
Title
Pressure pain threshold
Description
measured by electronic algometer
Time Frame
Measured pre and post treatment, 4 weeks after treatment and 8 weeks after treatment
Title
Global perceived effect
Description
measured by global perceived rating scale
Time Frame
Measured pre and post treatment, 4 weeks after treatment and 8 weeks after treatment
Title
Self-efficacy
Description
measured by The Pain Self-Efficacy Questionnaire
Time Frame
Measured pre and post treatment, 4 weeks after treatment and 8 weeks after treatment
Title
Catastrophizing
Description
measure by pain catastrophizing scale
Time Frame
Measured pre and post treatment, 4 weeks after treatment and 8 weeks after treatment
Title
kinesiophobia
Description
measure by TAMPA scale
Time Frame
Measured pre and post treatment, 4 weeks after treatment and 8 weeks after treatment
Title
McGuill
Description
measure by Mcguill scale
Time Frame
Measured pre and post treatment, 4 weeks after treatment and 8 weeks after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
sandro Groisman
Organizational Affiliation
UFCSPA Federal University of Health Science of Porto Alegre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Geraldo Jotz, Phd
Organizational Affiliation
UFCSPA Federal University of Health Science of Porto Alegre
Official's Role
Study Director
Facility Information:
Facility Name
Sandro Groisman
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90130061
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of the Effect of the OMT Exercises Education for Pain in Participants With Cervical Pain
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