Low Back Pain, MechanicalNCT00135239
Study Care Versus Usual Care for Acute Mechanical Lower Back Pain
A study testing Study care in people with Low Back Pain, Mechanical, run by University of British Columbia at 1 site in Canada.
Trial summary
The most common work-related injury in British Columbia every year is a lower back injury. The many different treatment options that are available to workers with a back injury have often led to confusion and frustration. Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Low Back Pain, Mechanical
- What is being tested?
- Study care
- Type of treatment
- Surgery or procedure
- How many people
- 88 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2006to Jun 2008
- Phase
- Interventional
- 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 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Residents of British Columbia with mechanical lower back pain
- Acute lower back pain with symptoms lasting 2-4 weeks
- Satisfy the Quebec Task Force Classification of Spinal Disorders Categories 1 and 2
Who cannot join
- Other significant spinal pathology
- Pregnancy
- Patients with Workers' Compensation Board (WCB) claims
- Persistent pain in other areas of the spine
Trial locations and contacts
1 site in 1 country.
Canada1 site
Medical Rapid Access Spine Clinic
Vancouver, British Columbia, V5Z 3J5
About this study
The most common work-related injury in British Columbia every year is a lower back injury. The many different treatment options that are available to workers with a back injury have often led to confusion and frustration. New back pain research has shown which combinations of treatments are most helpful, but has also shown that many injured workers in British Columbia do not have these treatments made readily available to them. This research study is designed to accurately determine whether or not providing patients suffering from acute back injuries with a combination of all of these recommended treatments, will improve their function, quality of life and return to work.
Read the detailed description
Objectives:
To determine if evidence-based care (EBC) is more effective than usual care (UC) in improving the functional status of patients with acute mechanical lower back pain. Our secondary objectives are to determine if EBC is effective in improving patient quality of life or time to return to work.
Research Methodology:
Design: This is a two arm, parallel design, randomized trial. Eligibility: Inclusion criteria are residents of British Columbia with mechanical lower back pain (Quebec Task Force on Spinal Disorders Classification categories 1 or 2) of up to four weeks duration.
Recruitment:
All study patients will be recruited from the patient population currently referred for assessment at the Combined Neurosurgical and Orthopaedic Spine Program (CNOSP) outpatient clinic (OPC).
Randomisation:
Patients will be randomized to receive treatment in either the CNOSP outpatient clinic (EBC) or from their family physicians (UC).
Intervention:
All study patients will be assessed initially by a physician in the CNOSP outpatient clinic to confirm that they meet the inclusion/exclusion criteria of the study. Patients receiving the EBC intervention will then receive re-assurance, advice to avoid passive treatments, acetominophen (except where contraindicated) for a period of 2-4 weeks, a four week course of lumbar spine spinal manipulative therapy administered by a CNOSP Chiropractor and advice to return to work in some capacity within eight weeks following the start of treatment. Patients randomized to the UC treatment arm will undergo the treatment(s) recommended by their family physicians.
Outcomes of Interest:
Primary Outcome: Our primary outcome of interest is the difference in the mean changes in functional improvement at sixteen weeks after the start of treatment, defined as the change in modified Roland Disability (RDQ) scores, between the EBC and the UC patient groups.
Secondary Outcomes: Secondary outcomes of interest are the difference in the mean changes in functional improvement at eight weeks and twenty-four weeks after the start of treatment defined as change in modified Roland Disability (RDQ) scores, differences in time to return to work and differences in the 'Bodily Pain and 'Physical Functioning' domains of the SF-36 questionnaire, between the EBC and the UC patient groups.
Statistical Analysis:
The RDQ scores in the two groups will be compared using the Student's T Test. Analysis of co-variance will be used if necessary to adjust for a difference in baseline functional status using baseline RDQ scores as a co-variate. Time to return to work will be compared using Kaplan Meier survival analysis. A between group comparison of survival will be performed using the log-rank test. SF 36 scores will be normalized and the Bodily Pain" and Physical Functioning scales will be compared between the EBC and UC groups, again using an unpaired t-test and if necessary, analysis of covariance. Estimated sample size: 88 subjects are required based on a two-sided independent T Test. Power + 0.80, alpha + 0.05, mean difference + 3 points, standard deviation + 4.4 and allowing 25% for loss to follow-up.
Non-Scientific Summary:
The most common work-related injury in British Columbia every year is a lower back injury. The many different treatment options that are available to workers with a back injury have often led to confusion and frustration. New back pain research has shown which combinations of treatments are most helpful, but has also shown that many injured workers in British Columbia do not have these treatments made readily available to them. This research study is designed to accurately determine whether or not providing patients suffering from acute back injuries with a combination of all of these recommended treatments, will improve their function, quality of life and return to work.
Relevance:
- Why is this study a high priority for WCB funding?
Lower back injuries remain the single most common category of claim for loss made by injured workers. A recent study has shown that the majority of workers in British Columbia with lower back injuries are now receiving treatments that are inconsistent with internationally developed, evidence-based clinical practice guidelines. In addition, a preliminary research study has shown that many aspects of patient recovery from a lower back injury are enhanced by the use of guideline-recommended treatments when compared with guideline discordant treatments.
The proposed study will accurately determine the value of treating lower back-injured patients with a combination of evidence-based treatments. In addition, the results of this study have the potential to significantly impact many issues that are of key importance to the WCB including improving the quality of life of patients with acute lower back injuries, reducing the use of inappropriate treatments that may promote disability and reducing the costs associated with the treatment of these patients.
- What impact will research outcomes have on BC workplaces?
The outcomes of this research study will help clarify the uncertainty that currently exists with respect to which treatments or combination of treatments, are most helpful for lower back-injured workers. The results of this study have the potential to greatly improve the treatment and/or rehabilitation that these patients are currently receiving in British Columbia, and therefore reduce the disability that is associated with a work-related lower back injury.
- Conditions
- Low Back Pain, Mechanical
- Being tested
- Study care, Usual care
- Keywords
- back, Lower Mechanical Back Pain, Rehabilitation
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study careProcedure or surgery
All study patients will be assessed initially by a physician in the CNOSP outpatient clinic to confirm that they meet the inclusion/exclusion criteria of the study. Patients receiving the EBC intervention will then receive re-assurance, advice to avoid passive treatments, acetominophen (except where contraindicated) for a period of 2-4 weeks, a four week course of lumbar spine spinal manipulative therapy administered by a CNOSP Chiropractor and advice to return to work in some capacity within eight weeks following the start of treatment. Patients randomized to the UC treatment arm will undergo the treatment(s) recommended by their family physicians.
Usual careProcedure or surgery
Patients randomized to the UC treatment arm will undergo the treatment(s) recommended by their family physicians.
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine if study-based care (SC) is more effective than usual care (UC) in the treatment of patients with acute mechanical lower back pain after 16 weeks
Measured: 16 weeks
Secondary outcomes (1)
To determine if SC is more effective than UC in improving the functional status of patients with acute mechanical lower back pain at 8 weeks and 24 weeks.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2005 (estimated)
- Study startJan 2006
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Low Back Pain, MechanicalStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Investigators
- Dr. Paul Bishop, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00135239
- Sponsor's protocol ID
- C04-0588
- Status last verified
- Jun 2008
- First submitted
- 23 Aug 2005
- Last updated
- 17 Jun 2008
- Results posted
- No
Publications
1. Bigos, S.J.B., O.R.; Braen, G.R.; et al., Clinical practice guideline number 4: Acute low back problems in adults. 1994, Agency for Health Care Policy and Research, Public Service, US Department of Health and Human Services: Rockville, MD. p. 65-0642. 2. Spitzer, W.O., et al., Scientific approach to the assessment and management of activity-related spinal disorders. A monograph for clinicians. Report of the Quebec Task Force on Spinal Disorders. Spine, 1987. 12 (suppl)(7): p. S1-59. 3. Practitioners, R.C.o.G., Clinical guidelines for the management of low back pain. Accessed April 6, 2001. 4. Kendall, N.A., Linton, S.J., Main, C.J., Guide to assessing psychosocial yellow flags in acute low back pain: risk factors for long-term disability and work loss. 1997, Accident Rehabilitation and Compensation Insurance Corporation of New Zealand and the National Health Committee.: Wellington (NZ). 5. Abenhaim, L., et al., The role of activity in the therapeutic management of back pain. Report of the International Paris Task Force on Back Pain. Spine, 2000. 25(4 Suppl): p. 1S-33S. 6. Bogduk, N., Draft evidence based clinical guidelines for the management of acute low back pain. 2000, National Health and Medical Research Council: Australia. 7. (CBO), C.B.v.d.I.T., Consensus Lumbosacrale Radicular Syndrome. June 1995: Utrecht. 8. Ruckenschmerzen, H.-. Empfehlungen zur Therapie von Ruckenschmerzen, Artzneimittelkommission der deutschen Arzteschaft (Treatment guidelines - backache. Drug Committee of German Medical Society). Z Artztl Fortbild Qualitatssich. 1997(91): p. 457-460. 9. Hansen, T.M., Bendix, T., Bunger, C.D., et al., Laenderesmerter Klaringsrapport fra dansk selskap for intern medecin. Ugeskr Laeger, 1996. 158(14 (Suppl)): p. 1-18. 10. Keel, P., Perinin, C.H., Schutz-Petitjean, D., et al., Chronicisation des douleurs du dos: Problematique issues. Rapport final du Programme National de Recherche No. 26B. Bale Editions EULAR. 1996. 11. Manniche, C., ed. Low back pain: Frequency, management and prevention from HTA perspective. 1999, Danish Institute for Health Technology Assessment. 12. Borkan, J., Reis, S., Werner, S. et al., Guidelines for treating low back pain in primary care. 1996, The Israeli Low Back Pain Guideline Group. p. 130: 145-51. 13. Koes, B.W., et al., Clinical guidelines for the management of low back pain in primary care: an international comparison. Spine, 2001. 26(22): p. 2504-13; discussion 2513-4. 14. Hayward, R.S., et al., Canadian physicians' attitudes about and preferences regarding clinical practice guidelines. Cmaj, 1997. 156(12): p. 1715-23. 15. Hayward, R.S., Clinical practice guidelines on trial. Cmaj, 1997. 156(12): p. 1725-7. 16. Basinski, A.S., Evaluation of clinical practice guidelines. Cmaj, 1995. 153(11): p. 1575-81. 17. Steven, I.D. and R.D. Fraser, Clinical practice guidelines. Particular reference to the management of pain in the lumbosacral spine. Spine, 1996. 21(13): p. 1593-6. 18. Burton, A.K. and G. Waddell, Clinical guidelines in the management of low back pain. Baillieres Clin Rheumatol, 1998. 12(1): p. 17-35. 19. Hart, L.G., R.A. Deyo, and D.C. Cherkin, Physician office visits for low back pain. Frequency, clinical evaluation, and treatment patterns from a U.S. national survey. Spine, 1995. 20(1): p. 11-9. 20. Cherkin, D.C., et al., Physician views about treating low back pain. The results of a national survey. Spine, 1995. 20(1): p. 1-9; discussion 9-10. 21. Bishop, P.B. and P.C. Wing, Compliance with clinical practice guidelines in family physicians managing worker's compensation board patients with acute lower back pain. Spine J, 2003. 3(6): p. 442-50. 22. Gonzalez-Urzelai V, P.-E.L., Lopez-de-Munain J, Routine primary care management of acute lower back pain: adherence to guidelines. Eur Spine J, 2003. 12: p. 589-594. 23. Bishop, P., Badii, M., Wing, P., Implementation of clinical practice guidelines in workers compensation board patients with acute mechanical back pain: a prospective randomized trial. Proceedings of the North American Spine Society 17th Annual Meeting. Spine Journal, 2002. 2: p. 62-63S. 24. Bishop, P.W., PC, The Implementation of Clinical Practice Guidelines in Family Physicians Managing Workers' Compensation Board Patients with Acute Lower Back Pain Using Patient Specific Direct Physician to Physician Communication: A Prospective Randomized Trial. Spine, 2003. Submitted. 25. McGuirk, B., et al., Safety, efficacy, and cost effectiveness of evidence-based guidelines for the management of acute low back pain in primary care. Spine, 2001. 26(23): p. 2615-22.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Care Versus Usual Care for Acute Mechanical Lower Back Pain
- ClinicalTrials.gov ID
- NCT00135239
- Acronym / sponsor ID
- C04-0588
- Conditions
- Low Back Pain, Mechanical
- Keywords
- back, Lower Mechanical Back Pain, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 25 Aug 2005 (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 most common work-related injury in British Columbia every year is a lower back injury. The many different treatment options that are available to workers with a back injury have often led to confusion and frustration. New back pain research has shown which combinations of treatments are most helpful, but has also shown that many injured workers in British Columbia do not have these treatments made readily available to them. This research study is designed to accurately determine whether or not providing patients suffering from acute back injuries with a combination of all of these recommended treatments, will improve their function, quality of life and return to work.
Detailed description
Objectives:
To determine if evidence-based care (EBC) is more effective than usual care (UC) in improving the functional status of patients with acute mechanical lower back pain. Our secondary objectives are to determine if EBC is effective in improving patient quality of life or time to return to work.
Research Methodology:
Design: This is a two arm, parallel design, randomized trial. Eligibility: Inclusion criteria are residents of British Columbia with mechanical lower back pain (Quebec Task Force on Spinal Disorders Classification categories 1 or 2) of up to four weeks duration.
Recruitment:
All study patients will be recruited from the patient population currently referred for assessment at the Combined Neurosurgical and Orthopaedic Spine Program (CNOSP) outpatient clinic (OPC).
Randomisation:
Patients will be randomized to receive treatment in either the CNOSP outpatient clinic (EBC) or from their family physicians (UC).
Intervention:
All study patients will be assessed initially by a physician in the CNOSP outpatient clinic to confirm that they meet the inclusion/exclusion criteria of the study. Patients receiving the EBC intervention will then receive re-assurance, advice to avoid passive treatments, acetominophen (except where contraindicated) for a period of 2-4 weeks, a four week course of lumbar spine spinal manipulative therapy administered by a CNOSP Chiropractor and advice to return to work in some capacity within eight weeks following the start of treatment. Patients randomized to the UC treatment arm will undergo the treatment(s) recommended by their family physicians.
Outcomes of Interest:
Primary Outcome: Our primary outcome of interest is the difference in the mean changes in functional improvement at sixteen weeks after the start of treatment, defined as the change in modified Roland Disability (RDQ) scores, between the EBC and the UC patient groups.
Secondary Outcomes: Secondary outcomes of interest are the difference in the mean changes in functional improvement at eight weeks and twenty-four weeks after the start of treatment defined as change in modified Roland Disability (RDQ) scores, differences in time to return to work and differences in the 'Bodily Pain and 'Physical Functioning' domains of the SF-36 questionnaire, between the EBC and the UC patient groups.
Statistical Analysis:
The RDQ scores in the two groups will be compared using the Student's T Test. Analysis of co-variance will be used if necessary to adjust for a difference in baseline functional status using baseline RDQ scores as a co-variate. Time to return to work will be compared using Kaplan Meier survival analysis. A between group comparison of survival will be performed using the log-rank test. SF 36 scores will be normalized and the Bodily Pain" and Physical Functioning scales will be compared between the EBC and UC groups, again using an unpaired t-test and if necessary, analysis of covariance. Estimated sample size: 88 subjects are required based on a two-sided independent T Test. Power + 0.80, alpha + 0.05, mean difference + 3 points, standard deviation + 4.4 and allowing 25% for loss to follow-up.
Non-Scientific Summary:
The most common work-related injury in British Columbia every year is a lower back injury. The many different treatment options that are available to workers with a back injury have often led to confusion and frustration. New back pain research has shown which combinations of treatments are most helpful, but has also shown that many injured workers in British Columbia do not have these treatments made readily available to them. This research study is designed to accurately determine whether or not providing patients suffering from acute back injuries with a combination of all of these recommended treatments, will improve their function, quality of life and return to work.
Relevance:
- Why is this study a high priority for WCB funding?
Lower back injuries remain the single most common category of claim for loss made by injured workers. A recent study has shown that the majority of workers in British Columbia with lower back injuries are now receiving treatments that are inconsistent with internationally developed, evidence-based clinical practice guidelines. In addition, a preliminary research study has shown that many aspects of patient recovery from a lower back injury are enhanced by the use of guideline-recommended treatments when compared with guideline discordant treatments.
The proposed study will accurately determine the value of treating lower back-injured patients with a combination of evidence-based treatments. In addition, the results of this study have the potential to significantly impact many issues that are of key importance to the WCB including improving the quality of life of patients with acute lower back injuries, reducing the use of inappropriate treatments that may promote disability and reducing the costs associated with the treatment of these patients.
- What impact will research outcomes have on BC workplaces?
The outcomes of this research study will help clarify the uncertainty that currently exists with respect to which treatments or combination of treatments, are most helpful for lower back-injured workers. The results of this study have the potential to greatly improve the treatment and/or rehabilitation that these patients are currently receiving in British Columbia, and therefore reduce the disability that is associated with a work-related lower back injury.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Residents of British Columbia with mechanical lower back pain
- Acute lower back pain with symptoms lasting 2-4 weeks
- Satisfy the Quebec Task Force Classification of Spinal Disorders Categories 1 and 2
Key exclusion criteria (4 listed)
- Other significant spinal pathology
- Pregnancy
- Patients with Workers' Compensation Board (WCB) claims
- Persistent pain in other areas of the spine
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 |
|---|---|---|
| Study careAll study patients will be assessed initially by a physician in the CNOSP outpatient clinic to confirm that they meet the inclusion/exclusion criteria of the study. Patients receiving the EBC intervention will then receive re-assurance, advice to avoid passive treatments, acetominophen (except where contraindicated) for a period of 2-4 weeks, a four week course of lumbar spine spinal manipulative therapy administered by a CNOSP Chiropractor and advice to return to work in some capacity within eight weeks following the start of treatment. Patients randomized to the UC treatment arm will undergo the treatment(s) recommended by their family physicians. | Procedure or surgery | – |
| Usual carePatients randomized to the UC treatment arm will undergo the treatment(s) recommended by their family physicians. | Procedure or surgery | – |
Primary outcome
To determine if study-based care (SC) is more effective than usual care (UC) in the treatment of patients with acute mechanical lower back pain after 16 weeks
Time frame: 16 weeks
1 secondary outcome
To determine if SC is more effective than UC in improving the functional status of patients with acute mechanical lower back pain at 8 weeks and 24 weeks.
Time frame: 24 weeks
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 17 Jun 2008.
- Background1. Bigos, S.J.B., O.R.; Braen, G.R.; et al., Clinical practice guideline number 4: Acute low back problems in adults. 1994, Agency for Health Care Policy and Research, Public Service, US Department of Health and Human Services: Rockville, MD. p. 65-0642. 2. Spitzer, W.O., et al., Scientific approach to the assessment and management of activity-related spinal disorders. A monograph for clinicians. Report of the Quebec Task Force on Spinal Disorders. Spine, 1987. 12 (suppl)(7): p. S1-59. 3. Practitioners, R.C.o.G., Clinical guidelines for the management of low back pain. Accessed April 6, 2001. 4. Kendall, N.A., Linton, S.J., Main, C.J., Guide to assessing psychosocial yellow flags in acute low back pain: risk factors for long-term disability and work loss. 1997, Accident Rehabilitation and Compensation Insurance Corporation of New Zealand and the National Health Committee.: Wellington (NZ). 5. Abenhaim, L., et al., The role of activity in the therapeutic management of back pain. Report of the International Paris Task Force on Back Pain. Spine, 2000. 25(4 Suppl): p. 1S-33S. 6. Bogduk, N., Draft evidence based clinical guidelines for the management of acute low back pain. 2000, National Health and Medical Research Council: Australia. 7. (CBO), C.B.v.d.I.T., Consensus Lumbosacrale Radicular Syndrome. June 1995: Utrecht. 8. Ruckenschmerzen, H.-. Empfehlungen zur Therapie von Ruckenschmerzen, Artzneimittelkommission der deutschen Arzteschaft (Treatment guidelines - backache. Drug Committee of German Medical Society). Z Artztl Fortbild Qualitatssich. 1997(91): p. 457-460. 9. Hansen, T.M., Bendix, T., Bunger, C.D., et al., Laenderesmerter Klaringsrapport fra dansk selskap for intern medecin. Ugeskr Laeger, 1996. 158(14 (Suppl)): p. 1-18. 10. Keel, P., Perinin, C.H., Schutz-Petitjean, D., et al., Chronicisation des douleurs du dos: Problematique issues. Rapport final du Programme National de Recherche No. 26B. Bale Editions EULAR. 1996. 11. Manniche, C., ed. Low back pain: Frequency, management and prevention from HTA perspective. 1999, Danish Institute for Health Technology Assessment. 12. Borkan, J., Reis, S., Werner, S. et al., Guidelines for treating low back pain in primary care. 1996, The Israeli Low Back Pain Guideline Group. p. 130: 145-51. 13. Koes, B.W., et al., Clinical guidelines for the management of low back pain in primary care: an international comparison. Spine, 2001. 26(22): p. 2504-13; discussion 2513-4. 14. Hayward, R.S., et al., Canadian physicians' attitudes about and preferences regarding clinical practice guidelines. Cmaj, 1997. 156(12): p. 1715-23. 15. Hayward, R.S., Clinical practice guidelines on trial. Cmaj, 1997. 156(12): p. 1725-7. 16. Basinski, A.S., Evaluation of clinical practice guidelines. Cmaj, 1995. 153(11): p. 1575-81. 17. Steven, I.D. and R.D. Fraser, Clinical practice guidelines. Particular reference to the management of pain in the lumbosacral spine. Spine, 1996. 21(13): p. 1593-6. 18. Burton, A.K. and G. Waddell, Clinical guidelines in the management of low back pain. Baillieres Clin Rheumatol, 1998. 12(1): p. 17-35. 19. Hart, L.G., R.A. Deyo, and D.C. Cherkin, Physician office visits for low back pain. Frequency, clinical evaluation, and treatment patterns from a U.S. national survey. Spine, 1995. 20(1): p. 11-9. 20. Cherkin, D.C., et al., Physician views about treating low back pain. The results of a national survey. Spine, 1995. 20(1): p. 1-9; discussion 9-10. 21. Bishop, P.B. and P.C. Wing, Compliance with clinical practice guidelines in family physicians managing worker's compensation board patients with acute lower back pain. Spine J, 2003. 3(6): p. 442-50. 22. Gonzalez-Urzelai V, P.-E.L., Lopez-de-Munain J, Routine primary care management of acute lower back pain: adherence to guidelines. Eur Spine J, 2003. 12: p. 589-594. 23. Bishop, P., Badii, M., Wing, P., Implementation of clinical practice guidelines in workers compensation board patients with acute mechanical back pain: a prospective randomized trial. Proceedings of the North American Spine Society 17th Annual Meeting. Spine Journal, 2002. 2: p. 62-63S. 24. Bishop, P.W., PC, The Implementation of Clinical Practice Guidelines in Family Physicians Managing Workers' Compensation Board Patients with Acute Lower Back Pain Using Patient Specific Direct Physician to Physician Communication: A Prospective Randomized Trial. Spine, 2003. Submitted. 25. McGuirk, B., et al., Safety, efficacy, and cost effectiveness of evidence-based guidelines for the management of acute low back pain in primary care. Spine, 2001. 26(23): p. 2615-22.
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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.
Dr. Paul Bishop, MD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Study care in people with Low Back Pain, Mechanical, run by University of British Columbia 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 4 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 17 Jun 2008. 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?
To determine if study-based care (SC) is more effective than usual care (UC) in the treatment of patients with acute mechanical lower back pain after 16 weeks (time frame: 16 weeks). 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 NCT00135239, which also lists 1 linked publication.
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 17 Jun 2008.