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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03085355
Enrollment
70
Registered
2017-03-21
Start date
2017-06-01
Completion date
2018-12-01
Last updated
2019-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neck Pain, Pain, Neck

Keywords

neck pain

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

Interventions

PROCEDUREExercises and PNE

Exercise for stretching and strength for neck muscles and pain neuroscience education

PROCEDUREOsteopathic manipulative treatment

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

Sponsors

Instituto Brasileiro de Osteopatia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Pain intensityMeasured pre and post treatment, 4 weeks after treatment and 8 weeks after treatmentmeasured by numeric rating scale

Secondary

MeasureTime frameDescription
Functionality and disabilityMeasured pre and post treatment, 4 weeks after treatment and 8 weeks after treatmentmeasured by Neck Disability Scale
Range of motionMeasured pre and post treatment, 4 weeks after treatment and 8 weeks after treatmentmeasured by CROM device
Pressure pain thresholdMeasured pre and post treatment, 4 weeks after treatment and 8 weeks after treatmentmeasured by electronic algometer
kinesiophobiaMeasured pre and post treatment, 4 weeks after treatment and 8 weeks after treatmentmeasure by TAMPA scale
Self-efficacyMeasured pre and post treatment, 4 weeks after treatment and 8 weeks after treatmentmeasured by The Pain Self-Efficacy Questionnaire
CatastrophizingMeasured pre and post treatment, 4 weeks after treatment and 8 weeks after treatmentmeasure by pain catastrophizing scale
McGuillMeasured pre and post treatment, 4 weeks after treatment and 8 weeks after treatmentmeasure by Mcguill scale
Global perceived effectMeasured pre and post treatment, 4 weeks after treatment and 8 weeks after treatmentmeasured by global perceived rating scale

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026