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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

December 10, 2010
June 9, 2011
November 2010
January 2011   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01258543 on ClinicalTrials.gov Archive Site
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Osteopathic Evaluation on Patients With Non-specific Back Pain: An Inter-examiner Reliability Study
Osteopathic Evaluation on Patients With Non-specific Back Pain: An Observational Inter-examiner Reliability Study

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.

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.
Observational
Observational Model: Case-Only
Time Perspective: Cross-Sectional
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Not Provided
Non-Probability Sample

Community Sample
  • Inter-examiner Reliability
  • Location and Nature of Restriction or Lesion
  • 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
Non-specific back pain
Intervention: Other: General Osteopathic Evaluation

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
January 2011
January 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01258543
JAK-OST-1
Yes
Jaime Kirnan, Unaffiliated
Kirnan, Jaime
Not Provided
Study Director: René Pelletier, MSc., D.O
Study Director: Sabrina Silla, BSc., PT, DO
Principal Investigator: Jaime Kirnan, BSc., CAT(c)
Kirnan, Jaime
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP