Osteopathic Evaluation on Patients With Non-specific Back Pain: An Inter-examiner Reliability Study

This study has been completed.

Sponsor:

Information provided by:

Kirnan, Jaime

ClinicalTrials.gov Identifier:

NCT01258543

First received: December 10, 2010

Last updated: June 9, 2011

Last verified: June 2011

History of Changes

Purpose

The purpose of this study is to determine whether two osteopathic evaluators with less than 5 years experience will be able to determine the same location and nature of the primary lesion(s) or restriction(s)in patients with chronic non-specific back pain using a global osteopathic evaluation approach.

Condition	Intervention
Inter-examiner Reliability Location and Nature of Restriction or Lesion Non-specific Back Pain	Other: General Osteopathic Evaluation

Study Type:	Observational
Study Design:	Observational Model: Case-Only Time Perspective: Cross-Sectional
Official Title:	Osteopathic Evaluation on Patients With Non-specific Back Pain: An Observational Inter-examiner Reliability Study

Resource links provided by NLM:

MedlinePlus related topics: Back Pain

U.S. FDA Resources

Further study details as provided by Kirnan, Jaime:

Primary Outcome Measures:

Inter-examiner reliability [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
Inter-examiner reliability between two evaluators for nature and location of primary restriction(s), lesion(s) found during a global osteopathic evaluation

Enrollment:	20
Study Start Date:	November 2010
Study Completion Date:	January 2011
Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Non-specific back pain	Other: General Osteopathic Evaluation 2 general osteopathic evaluations of approximately 1 hour in duration done consecutively on the same day with a 15 minute break between evaluations

Detailed Description:

Back pain is one of the leading causes of consultation for rehabilitation. Establishing a diagnosis in the initial patient assessment is essential to choosing a specific treatment plan for that patient, regardless of the type of therapy the patient chooses to pursue. Evidence based medicine is the current gold standard for most manual-therapy professions, and there has been a great deal of research performed in an attempt to give credibility to the one tool that all manual therapy professions share in common: palpation. Few studies have been able to demonstrate an acceptable rate of inter-examiner reliability for palpation. This study will combine a global testing regime, consensus training for evaluators, and access to history of injury with symptomatic subjects to verify the inter-examiner reliability of an osteopathic evaluation on patients with chronic, non-specific low back pain.

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Community Sample

Criteria

Inclusion Criteria:

Men and women ages 18-60
Must have a history of non-specific back pain (not due to any known pathology eg. disc herniation or disc degenerative disease) that is currently not irritated and has not been, in the past 8 weeks
Must be available for 3 consecutive hour

Exclusion Criteria:

Patients with a known cause for their back pain
Patients who have had a flare up of symptoms within the last 8 weeks
Patients who are currently undergoing any rehabilitation or who have received manual treatment in the last 8 weeks.
Patients who are taking daily medications for pain
Pregnant women
Major medical conditions: fractures, degenerative arthritis, inflammatory disorders, ankylosing spondylitis, multiple sclerosis, cancer, paralysis stroke or recent concussion history
Any other conditions that would prevent the participant from completing the evaluation

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01258543

Locations

Canada, Quebec
Concordia Physio Sport
Brossard, Quebec, Canada, J4Z 1A7

Sponsors and Collaborators

Kirnan, Jaime

Investigators

Study Director:	René Pelletier, MSc., D.O
Study Director:	Sabrina Silla, BSc., PT, DO
Principal Investigator:	Jaime Kirnan, BSc., CAT(c)

More Information

Publications:

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Responsible Party:	Jaime Kirnan, Unaffiliated
ClinicalTrials.gov Identifier:	NCT01258543 History of Changes
Other Study ID Numbers:	JAK-OST-1
Study First Received:	December 10, 2010
Last Updated:	June 9, 2011
Health Authority:	Canada: Comité central d'éthique de la recherche du ministre de la Santé et des Services sociaux

Keywords provided by Kirnan, Jaime:

Global osteopathic evaluation
Non-specific back pain
Inter-examiner reliability

Additional relevant MeSH terms:

Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 21, 2013

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