Home
Search
Study Topics
Glossary
|
|
|
|
|
Tracking Information | |||||||||
---|---|---|---|---|---|---|---|---|---|
First Received Date † | December 21, 2005 | ||||||||
Last Updated Date | November 16, 2007 | ||||||||
Start Date † | October 2003 | ||||||||
Current Primary Outcome Measures † |
Patient-rated pain (0-11 box scale) [ Time Frame: short term = 12 weeks; long term = 52 weeks ] | ||||||||
Original Primary Outcome Measures † | Same as current | ||||||||
Change History | Complete list of historical versions of study NCT00269321 on ClinicalTrials.gov Archive Site | ||||||||
Current Secondary Outcome Measures † |
|
||||||||
Original Secondary Outcome Measures † | Same as current | ||||||||
Descriptive Information | |||||||||
Brief Title † | Chiropractic and Exercise for Seniors With Low Back Pain | ||||||||
Official Title † | Randomized Clinical Trial of Chiropractic Manual Therapy Plus Home Exercise, Supervised Exercise Plus Home Exercise and Home Exercise Alone For Individuals 65 and Over With Chronic Mechanical Low Back Pain | ||||||||
Brief Summary | The purpose of this randomized clincal trial is to assess the relative effectiveness of three conservative treatment approaches for seniors with chronic low back pain: 1) chiropractic manual treatment plus home exercise, 2) supervised exercise plus home exercise and 3) home exercise alone. |
||||||||
Detailed Description | Low back pain (LBP) is a significant health problem for both young and geriatric individuals. Of particular concern is that conditions associated with LBP, such as impaired strength and flexibility, can have very serious consequences for an older individual's independence and overall health. The broad, long-term objective of this research is to identify effective therapies for low back pain (LBP) and to discover the best methods for enhancing health and functional capacity in the elderly population. This study is a multi-methods clinical trial consisting of a randomized clinical trial (RCT), a cost-effectiveness study alongside the RCT, and a qualitative study nested in the RCT. This trial builds upon a previous study of chiropractic and exercise funded by HRSA, and focuses on elderly patients with sub-acute and chronic low back pain. PRIMARY AIMS
SECONDARY AIMS
|
||||||||
Study Phase | Phase II | ||||||||
Study Type † | Interventional | ||||||||
Study Design † | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study | ||||||||
Condition † | Low Back Pain | ||||||||
Intervention † |
|
||||||||
Study Arms / Comparison Groups | |||||||||
Publications * | Maiers MJ, Hartvigsen J, Schulz C, Schulz K, Evans RL, Bronfort G. Chiropractic and exercise for seniors with low back pain or neck pain: the design of two randomized clinical trials. BMC Musculoskelet Disord. 2007 Sep 18;8:94. | ||||||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
|||||||||
Recruitment Information | |||||||||
Recruitment Status † | Active, not recruiting | ||||||||
Enrollment † | 240 | ||||||||
Estimated Completion Date | March 2008 | ||||||||
Primary Completion Date | |||||||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
|
||||||||
Gender | Both | ||||||||
Ages | 65 Years and older | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts †† | |||||||||
Location Countries † | United States | ||||||||
Expanded Access Status | |||||||||
Administrative Information | |||||||||
NCT ID † | NCT00269321 | ||||||||
Responsible Party | |||||||||
Secondary IDs †† | |||||||||
Study Sponsor † | Northwestern Health Sciences University | ||||||||
Collaborators †† |
|
||||||||
Investigators † |
|
||||||||
Information Provided By | Northwestern Health Sciences University | ||||||||
Verification Date | November 2007 | ||||||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |