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Completed

NCT Number: NCT03085355

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

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.

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Key information

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sandro Groisman

Porto Alegre, Rio Grande do Sul, 90130061, Brazil

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Exercises and PNE

Procedure

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

Osteopathic Manipulative Treatment

Procedure

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Instituto Brasileiro de Osteopatia

Other

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 21, 2017
Registry last updated
Nov 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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