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| Tracking Information | |||||
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| First Received Date ICMJE | October 9, 2003 | ||||
| Last Updated Date | August 16, 2006 | ||||
| Start Date ICMJE | September 2000 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00070915 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Massage, Meditation, and Tai Chi for Chronic Lower Back Pain | ||||
| Official Title ICMJE | Relaxation-Related CAM Therapies for Chronic Back Pain | ||||
| Brief Summary | This clinical trial is a preliminary study designed to prepare for a full-scale, randomized clinical trial of the effectiveness of tai chi, mediation, and therapeutic massage for chronic lower back pain in adults. |
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| Detailed Description | Despite the common use of complementary and alternative therapies for back pain, little is known about how such therapies compare with each other or with conventional medical therapies in terms of effectiveness and cost. This study will lay the groundwork for a full-scale trial that will evaluate the relative effectiveness and costs of three promising relaxation-related techniques (massage, tai chi, and meditation) that are appropriate for both younger and older adults with chronic lower back pain. The pilot study will identify and resolve unanticipated problems and estimate the sample sizes required for an adequately-powered, full-scale trial. Participants with chronic lower back pain will be randomly assigned to one of the following groups: tai chi, massage, meditation, or continued usual care (control group). The participants assigned to each intervention will be divided equally between persons under and over age 65. |
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| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Single Blind, Active Control, Factorial Assignment, Efficacy Study | ||||
| Condition ICMJE | Low Back Pain | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||
| 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 | 120 | ||||
| Completion Date | June 2003 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria
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| Gender | Both | ||||
| Ages | 20 Years to 64 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | |||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00070915 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | R01 AT000606-01 | ||||
| Study Sponsor ICMJE | National Center for Complementary and Alternative Medicine (NCCAM) | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | National Center for Complementary and Alternative Medicine (NCCAM) | ||||
| Verification Date | August 2006 | ||||
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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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