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

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.

Study Overview

• Status: Completed
• Conditions: Neck Pain; Pain, Neck
• Intervention / Treatment: Procedure: Exercises and PNE; Procedure: Osteopathic manipulative 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: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • RS
    • Porto Alegre, RS, Brazil, 90130061
      • Sandro Groisman

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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

Number of Arms

2

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	Procedure: Exercises and PNE; 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)	Procedure: Osteopathic manipulative treatment; 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	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	measured by Neck Disability Scale	Measured pre and post treatment, 4 weeks after treatment and 8 weeks after treatment
Range of motion	measured by CROM device	Measured pre and post treatment, 4 weeks after treatment and 8 weeks after treatment
Pressure pain threshold	measured by electronic algometer	Measured pre and post treatment, 4 weeks after treatment and 8 weeks after treatment
Global perceived effect	measured by global perceived rating scale	Measured pre and post treatment, 4 weeks after treatment and 8 weeks after treatment
Self-efficacy	measured by The Pain Self-Efficacy Questionnaire	Measured pre and post treatment, 4 weeks after treatment and 8 weeks after treatment
Catastrophizing	measure by pain catastrophizing scale	Measured pre and post treatment, 4 weeks after treatment and 8 weeks after treatment
kinesiophobia	measure by TAMPA scale	Measured pre and post treatment, 4 weeks after treatment and 8 weeks after treatment
McGuill	measure by Mcguill scale	Measured pre and post treatment, 4 weeks after treatment and 8 weeks after treatment

Collaborators and Investigators

• Sponsor: Instituto Brasileiro de Osteopatia
• 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): June 1, 2017
• Primary Completion (ACTUAL): June 1, 2018
• Study Completion (ACTUAL): December 1, 2018

Study Registration Dates

• First Submitted: March 19, 2017
• First Submitted That Met QC Criteria: March 19, 2017
• First Posted (ACTUAL): March 21, 2017

Study Record Updates

• Last Update Posted (ACTUAL): November 5, 2019
• Last Update Submitted That Met QC Criteria: November 2, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: neck pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Neck Pain
• Other Study ID Numbers: 003 (033)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No