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

Not Applicable

Completed

• Conditions: Pain, Neck; Neck Pain
• Interventions: Procedure: Exercises and PNE; Procedure: Osteopathic manipulative treatment

• Registration Number: NCT03085355
• Lead Sponsor: Instituto Brasileiro de Osteopatia

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

Study Timeline

• Study First Submitted: 2017-03-19
• Study First Submitted QC: 2017-03-19
• Study First Posted: 2017-03-21
• Study Start: 2017-06-01
• Primary Completion: 2018-06-01
• Study Completion: 2018-12-01
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-02
• Last Update Posted: 2019-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercises and PNE	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
Osteopathic manipulative treatment	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)

Primary Outcome Measures

Name	Time	Method
Pain intensity	Measured pre and post treatment, 4 weeks after treatment and 8 weeks after treatment	measured by numeric rating scale

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Sandro Groisman; 🇧🇷 Porto Alegre, RS, Brazil