Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01258543
Other study ID # JAK-OST-1
Secondary ID
Status Completed
Phase N/A
First received December 10, 2010
Last updated June 9, 2011
Start date November 2010
Est. completion date January 2011

Study information

Verified date June 2011
Source Kirnan, Jaime
Contact n/a
Is FDA regulated No
Health authority Canada: Comité central d'éthique de la recherche du ministre de la Santé et des Services sociaux
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date January 2011
Est. primary completion date January 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 60 Years
Eligibility 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 Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Canada Concordia Physio Sport Brossard Quebec

Sponsors (1)

Lead Sponsor Collaborator
Kirnan, Jaime

Country where clinical trial is conducted

Canada, 

References & Publications (43)

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. — View Citation

Bertilson BC, Grunnesjö 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. — View Citation

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. Erratum in: Ann Intern Med. 2008 Feb 5;148(3):247-8. — View Citation

Christensen HW, Vach W, Vach K, Manniche C, Haghfelt T, Hartvigsen L, Høilund-Carlsen PF. Palpation of the upper thoracic spine: an observer reliability study. J Manipulative Physiol Ther. 2002 Jun;25(5):285-92. Erratum in: J Manipulative Physiol Ther 2002 Jul-Aug;25(6):425. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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.

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. — View Citation

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. — View Citation

Haas M. Statistical methodology for reliability studies. J Manipulative Physiol Ther. 1991 Feb;14(2):119-32. — View Citation

Haas M. The reliability of reliability. J Manipulative Physiol Ther. 1991 Mar-Apr;14(3):199-208. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Landis JR, Koch GG. The measurement of observer agreement for categorical data. Biometrics. 1977 Mar;33(1):159-74. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Mior SA, McGregor M, Schut B. The role of experience in clinical accuracy. J Manipulative Physiol Ther. 1990 Feb;13(2):68-71. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2006 Jul 12. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

Viikari-Juntura E. Interexaminer reliability of observations in physical examinations of the neck. Phys Ther. 1987 Oct;67(10):1526-32. — View Citation

Vincent-Smith, B., & Gibbons, P. (1999). Inter-examiner and intra-examiner reliability of the standing forward flexion test. Manual Therapy; 10: 256-269

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. — View Citation

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. — View Citation

Walter SD, Eliasziw M, Donner A. Sample size and optimal designs for reliability studies. Stat Med. 1998 Jan 15;17(1):101-10. — View Citation

* Note: There are 43 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Inter-examiner reliability Inter-examiner reliability between two evaluators for nature and location of primary restriction(s), lesion(s) found during a global osteopathic evaluation Day 1 No
See also
  Status Clinical Trial Phase
Completed NCT04388007 - Non-specific Back Pain and Spinal Manipulation