Manual Therapy Versus Exercise on Knee Osteoarthritis
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ClinicalTrials.gov Identifier: NCT00988468 |
Recruitment Status
:
Terminated
(Study failed to recruit a sufficient number of subjects in the time anticipated.)
First Posted
: October 2, 2009
Last Update Posted
: November 16, 2010
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Sponsor:
Texas Tech University Health Sciences Center
Information provided by:
Texas Tech University Health Sciences Center
Tracking Information | ||||
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First Submitted Date ICMJE | September 30, 2009 | |||
First Posted Date ICMJE | October 2, 2009 | |||
Last Update Posted Date | November 16, 2010 | |||
Study Start Date ICMJE | October 2009 | |||
Actual Primary Completion Date | May 2010 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Suprapatellar effusion measured via diagnostic ultrasound [ Time Frame: Outcome measure will be measured 1 minute prior to intervention and 1 minute after intervention. ] | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | Complete list of historical versions of study NCT00988468 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Manual Therapy Versus Exercise on Knee Osteoarthritis | |||
Official Title ICMJE | Effects of Manual Therapy Versus Therapeutic Exercise on Knee Osteoarthritis: A Randomized Control Trial | |||
Brief Summary | Earlier research has shown that exercising while receiving manual therapy improves function and reduces pain in people with knee osteoarthritis. However, very little is known about the mechanisms by which manual therapy and exercise reduce pain and improve function. This study will ask subjects with knee osteoarthritis to receive one of the following interventions: (1) no treatment, (2) exercise only, or (3) manual therapy only. Measures will be taken of the patient's knee range of motion, knee swelling and pain before and after receiving the intervention. These measures will be analyzed to determine what effect exercise and manual therapy applied to the knee have on improving knee range of motion and reducing knee pain and swelling. Swelling will be measured using an ultrasound device which is used to take pictures inside the knee. This type of ultrasound measurement is painless and harmless. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Knee Osteoarthritis | |||
Intervention ICMJE |
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Study Arms |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Terminated | |||
Actual Enrollment ICMJE |
1 | |||
Original Estimated Enrollment ICMJE |
60 | |||
Actual Study Completion Date | August 2010 | |||
Actual Primary Completion Date | May 2010 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 89 Years (Adult, Senior) | |||
Accepts Healthy Volunteers | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00988468 | |||
Other Study ID Numbers ICMJE | L10-004 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Daniel R. Poulsen, II/Assistant Professor, Texas Tech University Health Sciences Center | |||
Study Sponsor ICMJE | Texas Tech University Health Sciences Center | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Texas Tech University Health Sciences Center | |||
Verification Date | November 2010 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |