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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02956863
Other study ID # 002
Secondary ID
Status Completed
Phase N/A
First received November 3, 2016
Last updated February 20, 2018
Start date December 2016
Est. completion date September 2017

Study information

Verified date February 2018
Source Instituto Brasileiro de Osteopatia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date September 2017
Est. primary completion date July 2017
Accepts healthy volunteers No
Gender All
Age group 20 Years to 55 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Osteopathic manipulative treatment
Osteopathic manipulative treatment delivered on pragmatic way.
Exercises
Exercise for stretching and strength for neck muscles

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 30 days after end treatment
Secondary range of motion measured by CROM device 30 days after end treatment
Secondary Pressure pain threshold measured by electronic algometer 30 days after end treatment
Secondary functionality and disability measured by Neck Disability Scale 30 days after end treatment
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