Manual and Manipulative Therapy for Low Back Pain
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|ClinicalTrials.gov Identifier: NCT00632060|
Recruitment Status : Unknown
Verified February 2008 by Samueli Institute for Information Biology.
Recruitment status was: Recruiting
First Posted : March 10, 2008
Last Update Posted : March 10, 2008
The specific aims of this research project are to determine feasibility of, and the comparative treatment effect size for, conducting a larger clinical trial of Manual/Manipulative Therapy (M/MT) in restoring peak performance in military personnel in operational environments and to evaluate the ability of the addition of M/MT to standard care to decrease pain and increase function for patients with low back pain.
The following two hypotheses will guide the data collection:
- The primary hypothesis is that the addition of acourse of M/MT to standard care for low back pain will decrease pain at 4 weeks when compared to standard care alone
- In addition, the secondary hypothesis will be that the addition of a course of M/MT to standard care for low back pain will decrease pain and increase function over 2 and 4 weeks when compared to standard care alone
|Condition or disease||Intervention/treatment||Phase|
|Low Back Pain||Procedure: Manual / Manipulative Therapy (M/MT)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Efficacy of Manual and Manipulative Therapy for Low Back Pain in Military Active Duty Personnel: A Feasibility Study|
|Study Start Date :||February 2008|
|Estimated Primary Completion Date :||July 2009|
|Estimated Study Completion Date :||July 2009|
No Intervention: 1
Standard Care Control Group - Participants randomized to the standard care group will continue their use of non-prescription or prescription medication and reduced duty loads, as prescribed by the credentialed medical provider.
Manual / Manipulative Therapy Group: Participants randomized to the M/MT group will receive a course of M/MT along with standard care. The patient will see the chiropractor twice a week for the entire course of the study, regardless of manipulation or not.
Procedure: Manual / Manipulative Therapy (M/MT)
Subjects will receive M/MT twice a week for 4 weeks
Other Name: M/MT
- Decreased pain [ Time Frame: Baseline, 2 weeks, 4 weeks ]
- Increased function [ Time Frame: Baseline, 2 weeks, 4 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00632060
|Contact: Roxana Delgado, MSemail@example.com|
|Contact: CPT Keith P Myers, MDfirstname.lastname@example.org|
|United States, Texas|
|Center for Integrative Medicine (CIM) at William Beaumont Army Medical Center; Soldier Family Medical Clinic (SFMC) at Ft. Bliss, TX||Recruiting|
|El Paso, Texas, United States, 79920|
|Contact: Roxana Delgado, MS 915-569-2857 email@example.com|
|Principal Investigator: CPT Keith P Myers, MD|
|Sub-Investigator: LTC Richard Petri, Jr., MD|
|Principal Investigator:||CPT Keith P Myers, MD||William Beaumont Army Medical Center|