Manual and Manipulative Therapy for Low Back Pain
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
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
|
- Study Details
- Tabular View
- Results Submitted
- Disclaimer
- How to Read a Study Record
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 |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Arm | Intervention/treatment |
---|---|
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.
|
|
Experimental: 2
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 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 35 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Active Duty
- Aged 18-35
- New episode of low back pain (LBP) or a reoccurence of a past episode of low back pain
Exclusion Criteria:
- LBP from other somatic tissues as determined by history, examination, and course (i.e. pain referred from visceral conditions)
- Radicular pain worse than back pain
- Co-morbid pathology or poor health conditions that may directly impact spinal pain. Patients who have case histories and physical examination findings indicating other than average health will be excluded from the study
- Bone and joint pathology contraindicating patient for M/MT. Patients with spinal fracture, tumors, infections, inflammatory arthropathies and significant osteoporosis will be referred for appropriate care and will be excluded from the study
- Other contraindications for M/MT of the lumbar spine and pelvis (i.e. bleeding disorders or anticoagulant therapy)
- Pregnancy (all potential female participants will undergo pregnancy testing)
- Use of manipulative care for any reason within the past month
- Unable to follow course of care for four weeks
- Unable to give informed consent for any reason
- Unable to confirm that they will not be deployed during the course of the study: "Will you be deployed, receiving orders for a distant temporary active duty assignment, attending training at a distant sight, or otherwise absent from Ft. Bliss over the next 6 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, MS | 915-569-3245/3245 | roxana.delgado@amedd.army.mil | |
Contact: CPT Keith P Myers, MD | 915-569-3245 | keith.myers@amedd.army.mil |
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 roxana.delgado@amedd.army.mil | |
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 |
Responsible Party: | CPT Keith P. Myers, MC / Chief, WBAMC Physical Medicine and Rehabilitation, William Beaumont Army Medical Center (WBAMC) |
ClinicalTrials.gov Identifier: | NCT00632060 |
Other Study ID Numbers: |
1 EA-0000055 WBAMC #06/05; USUHS TX781-AX-2 |
First Posted: | March 10, 2008 Key Record Dates |
Last Update Posted: | March 10, 2008 |
Last Verified: | February 2008 |
Low Back Pain Manual / Manipulative Therapy |
Back Pain Low Back Pain Pain Neurologic Manifestations |