- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01258543
Osteopathic Evaluation on Patients With Non-specific Back Pain: An Inter-examiner Reliability Study
June 9, 2011 updated by: Kirnan, Jaime
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Enrollment (Actual)
20
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Quebec
-
Brossard, Quebec, Canada, J4Z 1A7
- Concordia Physio Sport
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Community Sample
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Non-specific back pain
|
2 general osteopathic evaluations of approximately 1 hour in duration done consecutively on the same day with a 15 minute break between evaluations
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Day 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: René Pelletier, MSc., D.O
- Study Director: Sabrina Silla, BSc., PT, DO
- Principal Investigator: Jaime Kirnan, BSc., CAT(c)
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
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- Walter SD, Eliasziw M, Donner A. Sample size and optimal designs for reliability studies. Stat Med. 1998 Jan 15;17(1):101-10. doi: 10.1002/(sici)1097-0258(19980115)17:13.0.co;2-e.
- Licciardone JC, Brimhall AK, King LN. Osteopathic manipulative treatment for low back pain: a systematic review and meta-analysis of randomized controlled trials. BMC Musculoskelet Disord. 2005 Aug 4;6:43. doi: 10.1186/1471-2474-6-43.
- Chou R, Qaseem A, Snow V, Casey D, Cross JT Jr, Shekelle P, Owens DK; Clinical Efficacy Assessment Subcommittee of the American College of Physicians; American College of Physicians; American Pain Society Low Back Pain Guidelines Panel. Diagnosis and treatment of low back pain: a joint clinical practice guideline from the American College of Physicians and the American Pain Society. Ann Intern Med. 2007 Oct 2;147(7):478-91. doi: 10.7326/0003-4819-147-7-200710020-00006. Erratum In: Ann Intern Med. 2008 Feb 5;148(3):247-8.
- Stochkendahl MJ, Christensen HW, Hartvigsen J, Vach W, Haas M, Hestbaek L, Adams A, Bronfort G. Manual examination of the spine: a systematic critical literature review of reproducibility. J Manipulative Physiol Ther. 2006 Jul-Aug;29(6):475-85, 485.e1-10. doi: 10.1016/j.jmpt.2006.06.011.
- Vroomen PC, de Krom MC, Wilmink JT, Kester AD, Knottnerus JA. Diagnostic value of history and physical examination in patients suspected of lumbosacral nerve root compression. J Neurol Neurosurg Psychiatry. 2002 May;72(5):630-4. doi: 10.1136/jnnp.72.5.630.
- Degenhardt BF, Snider KT, Snider EJ, Johnson JC. Interobserver reliability of osteopathic palpatory diagnostic tests of the lumbar spine: improvements from consensus training. J Am Osteopath Assoc. 2005 Oct;105(10):465-73.
- Beal MC, Patriquin DA. Interexaminer agreement on palpatory diagnosis and patient self-assessment of disability: a pilot study. J Am Osteopath Assoc. 1995 Feb;95(2):97-100, 103-6.
- Bertilson BC, Grunnesjo M, Strender LE. Reliability of clinical tests in the assessment of patients with neck/shoulder problems-impact of history. Spine (Phila Pa 1976). 2003 Oct 1;28(19):2222-31. doi: 10.1097/01.BRS.0000089685.55629.2E.
- Christensen HW, Vach W, Vach K, Manniche C, Haghfelt T, Hartvigsen L, Hoilund-Carlsen PF. Palpation of the upper thoracic spine: an observer reliability study. J Manipulative Physiol Ther. 2002 Jun;25(5):285-92. doi: 10.1067/mmt.2002.124424. Erratum In: J Manipulative Physiol Ther 2002 Jul-Aug;25(6):425.
- Cleland JA, Childs JD, Fritz JM, Whitman JM. Interrater reliability of the history and physical examination in patients with mechanical neck pain. Arch Phys Med Rehabil. 2006 Oct;87(10):1388-95. doi: 10.1016/j.apmr.2006.06.011.
- 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
- French SD, Green S, Forbes A. Reliability of chiropractic methods commonly used to detect manipulable lesions in patients with chronic low-back pain. J Manipulative Physiol Ther. 2000 May;23(4):231-8. doi: 10.1067/mmt.2000.106101.
- Fritz JM, Delitto A, Vignovic M, Busse RG. Interrater reliability of judgments of the centralization phenomenon and status change during movement testing in patients with low back pain. Arch Phys Med Rehabil. 2000 Jan;81(1):57-61. doi: 10.1016/s0003-9993(00)90222-3.
- 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
- Haas M. Interexaminer reliability for multiple diagnostic test regimens. J Manipulative Physiol Ther. 1991 Feb;14(2):95-103.
- Haas M. Statistical methodology for reliability studies. J Manipulative Physiol Ther. 1991 Feb;14(2):119-32.
- Haas M. The reliability of reliability. J Manipulative Physiol Ther. 1991 Mar-Apr;14(3):199-208.
- Hall H, McIntosh G, Boyle C. Effectiveness of a low back pain classification system. Spine J. 2009 Aug;9(8):648-57. doi: 10.1016/j.spinee.2009.04.017. Epub 2009 Jun 4.
- Hestbaek L, Leboeuf-Yde C. Are chiropractic tests for the lumbo-pelvic spine reliable and valid? A systematic critical literature review. J Manipulative Physiol Ther. 2000 May;23(4):258-75. doi: 10.1067/mmt.2000.106097.
- Hicks GE, Fritz JM, Delitto A, Mishock J. Interrater reliability of clinical examination measures for identification of lumbar segmental instability. Arch Phys Med Rehabil. 2003 Dec;84(12):1858-64. doi: 10.1016/s0003-9993(03)00365-4.
- Horneij E, Hemborg B, Johnsson B, Ekdahl C. Clinical tests on impairment level related to low back pain: a study of test reliability. J Rehabil Med. 2002 Jul;34(4):176-82. doi: 10.1080/16501970213235.
- Huijbregts, P. A. (2002). Spinal motion palpation: a review of reliability studies. Manipulative and Physiological Therapeutics; 10(1): 24-39
- Jull G, Zito G, Trott P, Potter H, Shirley D. Inter-examiner reliability to detect painful upper cervical joint dysfunction. Aust J Physiother. 1997;43(2):125-129. doi: 10.1016/s0004-9514(14)60406-2.
- Keating JC Jr, Bergmann TF, Jacobs GE, Finer BA, Larson K. Interexaminer reliability of eight evaluative dimensions of lumbar segmental abnormality. J Manipulative Physiol Ther. 1990 Oct;13(8):463-70.
- Kokmeyer DJ, Van der Wurff P, Aufdemkampe G, Fickenscher TC. The reliability of multitest regimens with sacroiliac pain provocation tests. J Manipulative Physiol Ther. 2002 Jan;25(1):42-8. doi: 10.1067/mmt.2002.120418.
- Laslett M, Williams M. The reliability of selected pain provocation tests for sacroiliac joint pathology. Spine (Phila Pa 1976). 1994 Jun 1;19(11):1243-9. doi: 10.1097/00007632-199405310-00009.
- Leboeuf-Yde C, Kyvik KO. Is it possible to differentiate people with or without low-back pain on the basis of test of lumbopelvic dysfunction? J Manipulative Physiol Ther. 2000 Mar-Apr;23(3):160-7. doi: 10.1016/s0161-4754(00)90245-8.
- Maher C, Adams R. Reliability of pain and stiffness assessments in clinical manual lumbar spine examination. Phys Ther. 1994 Sep;74(9):801-9; discussion 809-11. doi: 10.1093/ptj/74.9.801.
- Meijne W, van Neerbos K, Aufdemkampe G, van der Wurff P. Intraexaminer and interexaminer reliability of the Gillet test. J Manipulative Physiol Ther. 1999 Jan;22(1):4-9. doi: 10.1016/s0161-4754(99)70098-9.
- Mior SA, McGregor M, Schut B. The role of experience in clinical accuracy. J Manipulative Physiol Ther. 1990 Feb;13(2):68-71.
- Murphy DR, Hurwitz EL, Nelson CF. A diagnosis-based clinical decision rule for spinal pain part 2: review of the literature. Chiropr Osteopat. 2008 Aug 11;16:7. doi: 10.1186/1746-1340-16-7.
- Perreault N, Brisson C, Dionne CE, Montreuil S, Punnett L. Agreement between a self-administered questionnaire on musculoskeletal disorders of the neck-shoulder region and a physical examination. BMC Musculoskelet Disord. 2008 Mar 17;9:34. doi: 10.1186/1471-2474-9-34.
- Pool JJ, Hoving JL, de Vet HC, van Mameren H, Bouter LM. The interexaminer reproducibility of physical examination of the cervical spine. J Manipulative Physiol Ther. 2004 Feb;27(2):84-90. doi: 10.1016/j.jmpt.2003.12.002.
- Robinson HS, Brox JI, Robinson R, Bjelland E, Solem S, Telje T. The reliability of selected motion- and pain provocation tests for the sacroiliac joint. Man Ther. 2007 Feb;12(1):72-9. doi: 10.1016/j.math.2005.09.004. Epub 2006 Jul 12.
- Schneider M, Erhard R, Brach J, Tellin W, Imbarlina F, Delitto A. Spinal palpation for lumbar segmental mobility and pain provocation: an interexaminer reliability study. J Manipulative Physiol Ther. 2008 Jul-Aug;31(6):465-73. doi: 10.1016/j.jmpt.2008.06.004.
- Seffinger MA, Najm WI, Mishra SI, Adams A, Dickerson VM, Murphy LS, Reinsch S. Reliability of spinal palpation for diagnosis of back and neck pain: a systematic review of the literature. Spine (Phila Pa 1976). 2004 Oct 1;29(19):E413-25. doi: 10.1097/01.brs.0000141178.98157.8e.
- 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
- Smedmark V, Wallin M, Arvidsson I. Inter-examiner reliability in assessing passive intervertebral motion of the cervical spine. Man Ther. 2000 May;5(2):97-101. doi: 10.1054/math.2000.0234.
- Viikari-Juntura E. Interexaminer reliability of observations in physical examinations of the neck. Phys Ther. 1987 Oct;67(10):1526-32. doi: 10.1093/ptj/67.10.1526.
- Vincent-Smith B, Gibbons P. Inter-examiner and intra-examiner reliability of the standing flexion test. Man Ther. 1999 May;4(2):87-93. doi: 10.1054/math.1999.0173.
- Wainner RS, Fritz JM, Irrgang JJ, Boninger ML, Delitto A, Allison S. Reliability and diagnostic accuracy of the clinical examination and patient self-report measures for cervical radiculopathy. Spine (Phila Pa 1976). 2003 Jan 1;28(1):52-62. doi: 10.1097/00007632-200301010-00014.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2010
Primary Completion (Actual)
January 1, 2011
Study Completion (Actual)
January 1, 2011
Study Registration Dates
First Submitted
December 10, 2010
First Submitted That Met QC Criteria
December 10, 2010
First Posted (Estimate)
December 13, 2010
Study Record Updates
Last Update Posted (Estimate)
June 13, 2011
Last Update Submitted That Met QC Criteria
June 9, 2011
Last Verified
June 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- JAK-OST-1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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