The Effect of Osteopathic Treatment in Pain and Functionality Individuals With Chronic Neck Pain
The Effect of Osteopathic Manipulative Treatment in Pain and Functionality Individuals With Nonspecific Chronic Neck Pain: Randomized Clinical Trial
1 other identifier
interventional
40
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2016
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 3, 2016
CompletedFirst Posted
Study publicly available on registry
November 7, 2016
CompletedStudy Start
First participant enrolled
December 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2017
CompletedFebruary 22, 2018
February 1, 2018
7 months
November 3, 2016
February 20, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Pain intensity
measured by numeric rating scale
30 days after end treatment
Secondary Outcomes (3)
range of motion
30 days after end treatment
Pressure pain threshold
30 days after end treatment
functionality and disability
30 days after end treatment
Study Arms (2)
Exercises
ACTIVE COMPARATORIndividuals with neck pain will receive a exercises program. Participants will receive treatments during 4 weeks, 1 treatments per week.
Osteopathic manipulative treatment
EXPERIMENTALIndividuals 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)
Interventions
Osteopathic manipulative treatment delivered on pragmatic way.
Eligibility Criteria
You may qualify if:
- Symptoms of chronic neck pain does not specify that persists for more than 3 months
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sandro Groisman
Porto Alegre, Rio Grande do Sul, 90130061, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sandro Groisman, MS
IBO Brazilian Osteopathic Institute
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- DO Ms
Study Record Dates
First Submitted
November 3, 2016
First Posted
November 7, 2016
Study Start
December 1, 2016
Primary Completion
July 1, 2017
Study Completion
September 1, 2017
Last Updated
February 22, 2018
Record last verified: 2018-02
Data Sharing
- IPD Sharing
- Will not share