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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | November 19, 2007 | ||||
| Last Updated Date | July 1, 2009 | ||||
| Start Date ICMJE | April 2008 | ||||
| Primary Completion Date | July 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Feasibility of recruitment for future full-scale trial [ Time Frame: 26 weeks ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Feasibility of recruitment for future full-scale trial [ Time Frame: 26 weeks ] | ||||
| Change History | Complete list of historical versions of study NCT00561652 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Participant compliance with education, exercise & chiropractic treatment protocol; Participant compliance with data collection; Estimation of variation in response in pain severity and disability for calculation of sample size for full-scale trial [ Time Frame: 26 weeks ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE |
Participant compliance with education, exercise & chiropractic treatment protocol; Participant compliance with data collection; Estimation of variation in response in pain severity and disability for calculation of sample size for full-scale trial [ Time Frame: 26 weeks ] | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Education/Exercise and Chiropractic for Chronic Back Pain | ||||
| Official Title ICMJE | Education/Exercise and Chiropractic for Chronic Back Pain | ||||
| Brief Summary | As a needed first step prior to a planned full-scale RCT, in order to assess the feasibility of the RCT and refine its design and protocols, we will perform a pilot study with the following objectives:1.To assess whether enough veterans with chronic LBP can be identified, meet eligibility criteria and be randomized to demonstrate that recruitment for a planned full-scale RCT is feasible. 2.To assess whether veterans with chronic LBP will adhere to protocol interventions per study protocol. 3.To assess whether veterans with chronic LBP will complete data collection per study protocol. 4.To obtain estimates of effect sizes and the corresponding standard errors of the primary efficacy outcome measures to estimate the required sample size of a planned full-scale RCT. |
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| Detailed Description | Chronic low back pain (LBP) is associated with poor health, lower quality of life, high costs, and is highly prevalent in veterans. Both chiropractic care and exercise have modestly reduced pain and/or improved function in randomized controlled trials (RCTs) of patients with chronic LBP. However, effects may not apply similarly to all populations. For example, there are no RCT data on chiropractic care for older (age >70) patients with chronic LBP, though with increased spinal arthritis, comorbidities and frailty, such patients may require modified chiropractic techniques and likely differ in response to chiropractic treatment. While a recent systematic review of RCTs predicted that a home exercise program that was individualized, high-dose, therapist-directed, and incorporated stretching and strengthening would be a meaningful treatment for chronic LBP, it also could provide a robust comparison group for other chronic LBP treatments. The combination of such a regimen and chiropractic care is predicted to have additive benefits for chronic LBP but this premise hasn't been directly tested. To further our aim of improving the health of chronic LBP patients, we plan an RCT in veterans with chronic LBP, to compare the effectiveness, cost-effectiveness and cost-utility of a tailored education/exercise (E/E) intervention alone vs. E/E plus chiropractic care. The demographics and medical complexity of the veteran population provide a great opportunity to test the appropriate role of chiropractic care for such patients with chronic LBP and to advance chronic LBP research and clinicalcare. Subjects will be recruited primarily from patients attending Minneapolis VAMC clinics with complaints of chronic LBP. Thirty eligible veterans will be randomized to E/E alone vs. E/E plus chiropractic care. All participants will receive E/E instruction in four 1-hr individual sessions over 8 weeks, including an individually designed, high dose, therapist-directed home exercise program. Chiropractic care will be delivered by chiropractors and follow standard protocols, with up to 12 sessions over 12 weeks. Participants randomized to E/E alone will attend 10 weekly exam/interview sessions so that their contact with providers is comparable to that received by participants who also receive chiropractic care. The recruitment goal is to generate the potential to randomize 6-10 participants/month. Recruitment feasibility will be assessed by tracking the number of patients who make initial inquiries, undergo screening and in-clinic evaluation, and are randomized. Further, reasons for nonparticipation and disqualification will be examined and described. Participant adherence to interventions will be defined as completing >3 of 4 education sessions, >20 hrs of home exercise, and >80% of recommended chiropractic visits or nonchiropractic follow-up exam/interviews. Adherence with clinic visits will be assessed with provider treatment logs. Home exercise compliance will be tracked by questionnaire. Participant adherence to data collection will be defined as >90% follow-up rates at each time point and assessed by tracking questionnaire completion rates. Descriptive data for the distributions of the primary and main secondary efficacy outcome measures will be used to calculate sample size and generate power tables for the full-scale trial. |
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| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study | ||||
| Condition ICMJE | Low Back Pain | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups |
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| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 30 | ||||
| Completion Date | July 2009 | ||||
| Primary Completion Date | July 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00561652 | ||||
| Responsible Party | Fink, Howard - Principal Investigator, Department of Veterans Affairs | ||||
| Study ID Numbers ICMJE | B5027R | ||||
| Study Sponsor ICMJE | Department of Veterans Affairs | ||||
| Collaborators ICMJE | Northwestern Health Sciences University | ||||
| Investigators ICMJE |
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| Information Provided By | Department of Veterans Affairs | ||||
| Verification Date | July 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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