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The Effect of Osteopathic Treatment in Pain and Functionality Individuals With Chronic Neck Pain

Primary Purpose

Neck Pain

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Osteopathic manipulative treatment
Exercises
Sponsored by
Instituto Brasileiro de Osteopatia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain

Eligibility Criteria

20 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Symptoms of chronic neck pain does not specify that persists for more than 3 months

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.

Sites / Locations

  • Sandro Groisman

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Exercises

Osteopathic manipulative treatment

Arm Description

Individuals with neck pain will receive a exercises program. Participants will receive treatments during 4 weeks, 1 treatments per week.

Individuals with neck pain in this group will also receive a exercises program and the participants will receive treatments during 4 weeks, 1 treatments per week associated with Osteopathic Manipulative Treatment (OMT)

Outcomes

Primary Outcome Measures

Pain intensity
measured by numeric rating scale

Secondary Outcome Measures

range of motion
measured by CROM device
Pressure pain threshold
measured by electronic algometer
functionality and disability
measured by Neck Disability Scale

Full Information

First Posted
November 3, 2016
Last Updated
February 20, 2018
Sponsor
Instituto Brasileiro de Osteopatia
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1. Study Identification

Unique Protocol Identification Number
NCT02956863
Brief Title
The Effect of Osteopathic Treatment in Pain and Functionality Individuals With Chronic Neck Pain
Official Title
The Effect of Osteopathic Manipulative Treatment in Pain and Functionality Individuals With Nonspecific Chronic Neck Pain: Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
December 2016 (Actual)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
September 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Brasileiro de Osteopatia

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine whether manipulative osteopathic treatment associated exercises improves pain and function in individuals with chronic non-specific neck pain
Detailed Description
The purpose of this study is to determine whether manipulative osteopathic treatment associated exercises improves pain and function in individuals with chronic non-specific neck pain Design: a randomized single blind placebo controlled trial will be conducted trial. Patients (n=40) with non-specific neck pain will be randomized to receive 1) osteopathic manipulative treatment and exercise (n=20) or 2) exercise alone (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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercises
Arm Type
Active Comparator
Arm Description
Individuals with neck pain will receive a exercises program. Participants will receive treatments during 4 weeks, 1 treatments per week.
Arm Title
Osteopathic manipulative treatment
Arm Type
Experimental
Arm Description
Individuals with neck pain in this group will also receive a exercises program and the participants will receive treatments during 4 weeks, 1 treatments per week associated with Osteopathic Manipulative Treatment (OMT)
Intervention Type
Procedure
Intervention Name(s)
Osteopathic manipulative treatment
Intervention Description
Osteopathic manipulative treatment delivered on pragmatic way.
Intervention Type
Procedure
Intervention Name(s)
Exercises
Intervention Description
Exercise for stretching and strength for neck muscles
Primary Outcome Measure Information:
Title
Pain intensity
Description
measured by numeric rating scale
Time Frame
30 days after end treatment
Secondary Outcome Measure Information:
Title
range of motion
Description
measured by CROM device
Time Frame
30 days after end treatment
Title
Pressure pain threshold
Description
measured by electronic algometer
Time Frame
30 days after end treatment
Title
functionality and disability
Description
measured by Neck Disability Scale
Time Frame
30 days after end treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Symptoms of chronic neck pain does not specify that persists for more than 3 months 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandro Groisman, MS
Organizational Affiliation
IBO Brazilian Osteopathic Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sandro Groisman
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90130061
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Effect of Osteopathic Treatment in Pain and Functionality Individuals With Chronic Neck Pain

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