- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03085355
Evaluation of the Effect of the OMT Exercises Education for Pain in Participants With Cervical Pain
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 Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
RS
-
Porto Alegre, RS, Brazil, 90130061
- Sandro Groisman
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / 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
|
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)
|
Osteopathic manipulative treatment associated exercise for stretching and strength for neck muscles and pain neuroscience education
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain intensity
Time Frame: Measured pre and post treatment, 4 weeks after treatment and 8 weeks after treatment
|
measured by numeric rating scale
|
Measured pre and post treatment, 4 weeks after treatment and 8 weeks after treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Functionality and disability
Time Frame: Measured pre and post treatment, 4 weeks after treatment and 8 weeks after treatment
|
measured by Neck Disability Scale
|
Measured pre and post treatment, 4 weeks after treatment and 8 weeks after treatment
|
Range of motion
Time Frame: Measured pre and post treatment, 4 weeks after treatment and 8 weeks after treatment
|
measured by CROM device
|
Measured pre and post treatment, 4 weeks after treatment and 8 weeks after treatment
|
Pressure pain threshold
Time Frame: Measured pre and post treatment, 4 weeks after treatment and 8 weeks after treatment
|
measured by electronic algometer
|
Measured pre and post treatment, 4 weeks after treatment and 8 weeks after treatment
|
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
|
Measured pre and post treatment, 4 weeks after treatment and 8 weeks after treatment
|
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
|
Measured pre and post treatment, 4 weeks after treatment and 8 weeks after treatment
|
Catastrophizing
Time Frame: Measured pre and post treatment, 4 weeks after treatment and 8 weeks after treatment
|
measure by pain catastrophizing scale
|
Measured pre and post treatment, 4 weeks after treatment and 8 weeks after treatment
|
kinesiophobia
Time Frame: Measured pre and post treatment, 4 weeks after treatment and 8 weeks after treatment
|
measure by TAMPA scale
|
Measured pre and post treatment, 4 weeks after treatment and 8 weeks after treatment
|
McGuill
Time Frame: Measured pre and post treatment, 4 weeks after treatment and 8 weeks after treatment
|
measure by Mcguill scale
|
Measured pre and post treatment, 4 weeks after treatment and 8 weeks after treatment
|
Collaborators and Investigators
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
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 003 (NuSkin International)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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