Recruiting

Manual TherapyManual and Manipulative Therapy for Low Back Pain

Sponsor:

Samueli Institute for Information Biology

Code:

NCT00632060

Conditions

Low Back Pain

Eligibility Criteria

Sex: All

Age: 18 - 35

Healthy Volunteers: Not accepted

Interventions

Manual / Manipulative Therapy (M/MT)

Study Details

Brief summary:

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:

1. 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
2. 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

Conditions

Low Back Pain

Study ID

NCT00632060

Start date

Feb, 2008

Status verified date

Feb, 2008

Completion date

Jul, 2009

Anticipated

Primary completion date

Jul, 2009

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 35

Healthy Volunteers: Not accepted

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?"

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

Manual / Manipulative Therapy (M/MT)

Subjects will receive M/MT twice a week for 4 weeks

Primary outcome measure

Decreased pain [ Time Frame: Baseline, 2 weeks, 4 weeks ]

Central Contacts and Locations

Central contacts

Roxana Delgado, MS

915-569-3245/3245 roxana.delgado@amedd.army.mil

CPT Keith P Myers, MD

915-569-3245 keith.myers@amedd.army.mil

Locations

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

Contacts

Roxana Delgado, MS

915-569-2857 roxana.delgado@amedd.army.mil

Principal Investigator:

CPT Keith P Myers, MD

More Information

Sponsor

Samueli Institute for Information Biology

Last update posted

Mar 10, 2008

Last verified

Feb, 2008

Keywords

Low Back Pain
Manual / Manipulative Therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Samueli Institute for Information Biology on 2008-03-10.