Inter-examiner ReliabilityNCT01258543
Osteopathic Evaluation on Patients With Non-specific Back Pain: An Inter-examiner Reliability Study
An observational study of Inter-examiner Reliability and Location and Nature of Restriction or Lesion, run by Kirnan, Jaime at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Inter-examiner Reliability, Location and Nature of Restriction or Lesion, Non-specific Back Pain
- What is being tested?
- General Osteopathic Evaluation
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2010to Jan 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Community Sample
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Inter-examiner Reliability, Location and Nature of Restriction or Lesion, Non-specific Back Pain
- Being tested
- General Osteopathic Evaluation
- Keywords
- Global osteopathic evaluation, Non-specific back pain, Inter-examiner reliability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
General Osteopathic EvaluationOther
2 general osteopathic evaluations of approximately 1 hour in duration done consecutively on the same day with a 15 minute break between evaluations
| Study group | Role | What they receive |
|---|---|---|
| Non-specific back pain | Not described Receives: Other: General Osteopathic Evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2010 (estimated)
- Study startNov 2010
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (43)Papers the sponsor has linked to this study.
- Other trials for Inter-examiner ReliabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kirnan, Jaime
- Investigators
- René Pelletier, MSc., D.O, Study directorSabrina Silla, BSc., PT, DO, Study directorJaime Kirnan, BSc., CAT(c), Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01258543
- Sponsor's protocol ID
- JAK-OST-1
- Status last verified
- Jun 2011
- First submitted
- 10 Dec 2010
- Last updated
- 13 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 7890559Bertilson 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.
PubMed 14520035Chou 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.
PubMed 17909209Christensen 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.
PubMed 12072848Cleland 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.
PubMed 17023251Comeaux, 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.
PubMed 16314679French 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.
PubMed 10820295Fritz 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.
PubMed 10638877Freyer, 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.
PubMed 2019826Haas M. Statistical methodology for reliability studies. J Manipulative Physiol Ther. 1991 Feb;14(2):119-32.
PubMed 2019821Haas M. The reliability of reliability. J Manipulative Physiol Ther. 1991 Mar-Apr;14(3):199-208.
PubMed 2045731Hall 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.
PubMed 19501026
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Osteopathic Evaluation on Patients With Non-specific Back Pain: An Observational Inter-examiner Reliability Study
- ClinicalTrials.gov ID
- NCT01258543
- Acronym / sponsor ID
- JAK-OST-1
- Conditions
- Inter-examiner Reliability, Location and Nature of Restriction or Lesion, Non-specific Back Pain
- Keywords
- Global osteopathic evaluation, Non-specific back pain, Inter-examiner reliability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Kirnan, Jaime
- Study start
- Nov 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 13 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-specific back pain | – | Other: General Osteopathic Evaluation |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Community Sample
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| General Osteopathic Evaluation2 general osteopathic evaluations of approximately 1 hour in duration done consecutively on the same day with a 15 minute break between evaluations | Other | Non-specific back pain |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2011.
- Background: PubMed 7890559Beal 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.
- Background: PubMed 14520035Bertilson 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.
- Background: PubMed 17909209Chou 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.
- Background: PubMed 12072848Christensen 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.
- Background: PubMed 17023251Cleland 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.
- BackgroundComeaux, 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
- Background: PubMed 16314679Degenhardt 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.
- Background: PubMed 10820295French 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.
- Background: PubMed 10638877Fritz 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.
- BackgroundFreyer, 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.
- BackgroundGhoukassian, 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
- Background: PubMed 2019826Haas M. Interexaminer reliability for multiple diagnostic test regimens. J Manipulative Physiol Ther. 1991 Feb;14(2):95-103.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
René Pelletier, MSc., D.O study director
Sabrina Silla, BSc., PT, DO study director
Jaime Kirnan, BSc., CAT(c) principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inter-examiner Reliability and Location and Nature of Restriction or Lesion, run by Kirnan, Jaime at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inter-examiner reliability (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01258543, which also lists 43 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2011.