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| ID | Type | Description | Link |
|---|---|---|---|
| WBAMC #06/05; USUHS TX781-AX-2 |
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| Name | Class |
|---|---|
| Palmer Center for Chiropractic Research (PCCR) | OTHER |
| William Beaumont Army Medical Center | FED |
| United States Army Fort Bliss | UNKNOWN |
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:
Musculoskeletal injuries are among the highest frequency injuries in military personnel(1). These may result from training exercises, normal job duties, or recreational activities (2). Such injuries may cause reduced levels of performance and therefore decrease military readiness (1). This prospective, randomized, clinical trial compares manual/manipulative therapy (M/MT) and standard care to standard care alone for episodes of low back pain. Patients will be randomized to standard care or standard care plus M/MT. Standard care consists of medication prescribed by the credentialed medical provider; M/MT will be delivered by the chiropractor physician. The trial time period will be 4 weeks with outcome measurements at intake, 2 weeks, and 4 weeks. Outcome measures include the Visual Analogue Scale (VAS) for pain, Roland-Morris Low Back Pain and Disability Questionnaire (RDQ), the Back Pain Functional Scale for assessing function (3), Global Improvement Questionnaire for patient perception regarding improvement in function, Patient Expectation and Patient Satisfaction Questionnaires to examine patient expectations toward care and reception of that care, and drug use and profiles. The SF-36 will be used to measure the general health component and quality of life of our sample (4). This will be a pragmatic study that will allow us the opportunity to develop further investigations leading to a larger scale and more robust clinical trial. In addition, this study will provide information on the challenges and opportunities involved in conducting clinical research concerning M/MT in a military setting and may lead to additional studies at a wider number of bases throughout the US.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | No Intervention | 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. | |
| 2 | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Manual / Manipulative Therapy (M/MT) | Procedure | Subjects will receive M/MT twice a week for 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Decreased pain | Baseline, 2 weeks, 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Increased function | Baseline, 2 weeks, 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Roxana Delgado, MS | Contact | 915-569-3245/3245 | roxana.delgado@amedd.army.mil | |
| CPT Keith P Myers, MD | Contact | 915-569-3245 | keith.myers@amedd.army.mil |
| Name | Affiliation | Role |
|---|---|---|
| CPT Keith P Myers, MD | William Beaumont Army Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Integrative Medicine (CIM) at William Beaumont Army Medical Center; Soldier Family Medical Clinic (SFMC) at Ft. Bliss, TX | Recruiting | El Paso | Texas | 79920 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23060056 | Derived | Goertz CM, Long CR, Hondras MA, Petri R, Delgado R, Lawrence DJ, Owens EF, Meeker WC. Adding chiropractic manipulative therapy to standard medical care for patients with acute low back pain: results of a pragmatic randomized comparative effectiveness study. Spine (Phila Pa 1976). 2013 Apr 15;38(8):627-34. doi: 10.1097/BRS.0b013e31827733e7. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 29, 2013 | |
| Reset | Jul 25, 2013 | |
| Release | Aug 28, 2013 | |
| Reset | Oct 31, 2013 | |
| Release | May 20, 2014 | |
| Reset | Jun 18, 2014 | |
| Release | May 10, 2016 | |
| Reset | Jun 14, 2016 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 29, 2013 | Jul 25, 2013 | |||
| Aug 28, 2013 |
| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D026201 | Musculoskeletal Manipulations |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
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| Oct 31, 2013 |
| May 20, 2014 | Jun 18, 2014 |
| May 10, 2016 | Jun 14, 2016 |
| D013568 |
| Pathological Conditions, Signs and Symptoms |