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

NCT ID: NCT03085355

Last Updated: 2019-11-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-01
• Study Completion Date: 2018-12-01

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

Conditions

Neck Pain; Pain, Neck

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Exercises and PNE

Intervention Type: PROCEDURE

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

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)

Group Type: EXPERIMENTAL

Osteopathic manipulative treatment

Intervention Type: PROCEDURE

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

Interventions

Exercises and PNE

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

Intervention Type: PROCEDURE

Osteopathic manipulative treatment

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

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto Brasileiro de Osteopatia

OTHER

Sponsor Role: lead

Responsible Party

Sandro Groisman, PT, DO, MSc

Master

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

sandro Groisman

Role: PRINCIPAL_INVESTIGATOR

UFCSPA Federal University of Health Science of Porto Alegre

Geraldo Jotz, Phd

Role: STUDY_DIRECTOR

UFCSPA Federal University of Health Science of Porto Alegre

Locations

Sandro Groisman

Porto Alegre, Rio Grande do Sul, Brazil

Countries

Brazil

Other Identifiers

003

Identifier Type: -

Identifier Source: org_study_id