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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
Instituto Brasileiro de Osteopatia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain focused on measuring neck pain

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
March 19, 2017
Last Updated
November 2, 2019
Sponsor
Instituto Brasileiro de Osteopatia
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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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