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

Neck Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03085355
• Other study ID #: 003
• Status: Completed
• Phase: N/A
• Start date: June 1, 2017
• Est. completion date: December 1, 2018

Study information

• Verified date: November 2019
• Source: Instituto Brasileiro de Osteopatia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 1, 2018
• Est. primary completion date: June 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Neck Pain
• Pain, Neck

Intervention

Procedure:
• Exercises and PNE
Exercise for stretching and strength for neck muscles and pain neuroscience education
• Osteopathic manipulative treatment
Osteopathic manipulative treatment associated exercise for stretching and strength for neck muscles and pain neuroscience education

Locations

Country	Name	City	State
Brazil	Sandro Groisman	Porto Alegre	RS

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Brasileiro de Osteopatia

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain intensity	measured by numeric rating scale	Measured pre and post treatment, 4 weeks after treatment and 8 weeks after treatment
Secondary	Functionality and disability	measured by Neck Disability Scale	Measured pre and post treatment, 4 weeks after treatment and 8 weeks after treatment
Secondary	Range of motion	measured by CROM device	Measured pre and post treatment, 4 weeks after treatment and 8 weeks after treatment
Secondary	Pressure pain threshold	measured by electronic algometer	Measured pre and post treatment, 4 weeks after treatment and 8 weeks after treatment
Secondary	Global perceived effect	measured by global perceived rating scale	Measured pre and post treatment, 4 weeks after treatment and 8 weeks after treatment
Secondary	Self-efficacy	measured by The Pain Self-Efficacy Questionnaire	Measured pre and post treatment, 4 weeks after treatment and 8 weeks after treatment
Secondary	Catastrophizing	measure by pain catastrophizing scale	Measured pre and post treatment, 4 weeks after treatment and 8 weeks after treatment
Secondary	kinesiophobia	measure by TAMPA scale	Measured pre and post treatment, 4 weeks after treatment and 8 weeks after treatment
Secondary	McGuill	measure by Mcguill scale	Measured pre and post treatment, 4 weeks after treatment and 8 weeks after treatment