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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01258543
Recruitment Status : Completed
First Posted : December 13, 2010
Last Update Posted : June 13, 2011
Information provided by:
Kirnan, Jaime

Brief Summary:
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 or disease Intervention/treatment
Inter-examiner Reliability Location and Nature of Restriction or Lesion Non-specific Back Pain Other: General Osteopathic Evaluation

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.

Study Type : Observational
Actual Enrollment : 20 participants
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
Study Start Date : November 2010
Primary Completion Date : January 2011
Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain
U.S. FDA Resources

Group/Cohort Intervention/treatment
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

Primary Outcome Measures :
  1. Inter-examiner reliability [ Time Frame: Day 1 ]
    Inter-examiner reliability between two evaluators for nature and location of primary restriction(s), lesion(s) found during a global osteopathic evaluation

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Community Sample

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01258543

Canada, Quebec
Concordia Physio Sport
Brossard, Quebec, Canada, J4Z 1A7
Sponsors and Collaborators
Kirnan, Jaime
Study Director: René Pelletier, MSc., D.O
Study Director: Sabrina Silla, BSc., PT, DO
Principal Investigator: Jaime Kirnan, BSc., CAT(c)

Comeaux, Z., Eland, D., Chila, A., Pheley, A., & Tate, M. (2001). Measurement challenges in physical diagnosis: refining inter-rater palpation, perception and communication. Journal of Bodywork and Movement Therapies; 5(4): 245-253
Freyer, G., McPherson, H. C., & O'Keefe, P. (2005). The effect of training on the inter-examiner and intra-examiner reliability of the seated flexion test and assessment of pelvic anatomical landmarks with palpation. International Journal of Osteopathic Medicine; 8: 131-138.
Ghoukassian, M., Nicholls, B., & McLaughlin, P. (2001). Inter-examiner reliability of the Johnson and Friedman percussion scan of the thoracic spine. Journal of Osteopathic Medicine; 4(1): 15-20
Huijbregts, P. A. (2002). Spinal motion palpation: a review of reliability studies. Manipulative and Physiological Therapeutics; 10(1): 24-39
Seffinger, M., Adams, A., Najm, W., Dickerson, V., Mishra, S. I., Reinsch, S., & Murphy, L. (2003). Spinal palpatory diagnostic procedures utilized by practitioners of spinal manipulation: annotated bibliography of content validity and reliability studies. Journal of the Canadian Chiropractic Association; 47(2): 93-109
Vincent-Smith, B., & Gibbons, P. (1999). Inter-examiner and intra-examiner reliability of the standing forward flexion test. Manual Therapy; 10: 256-269

Responsible Party: Jaime Kirnan, Unaffiliated Identifier: NCT01258543     History of Changes
Other Study ID Numbers: JAK-OST-1
First Posted: December 13, 2010    Key Record Dates
Last Update Posted: June 13, 2011
Last Verified: June 2011

Keywords provided by Kirnan, Jaime:
Global osteopathic evaluation
Non-specific back pain
Inter-examiner reliability

Additional relevant MeSH terms:
Back Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms