Manual and Manipulative Therapy for Low Back Pain

Status unconfirmed · Not applicable

Conditions studied: Low Back Pain

In brief

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

Key facts

Study ID

NCT00632060

Run by

Samueli Institute for Information Biology

People needed

100

Starts

2008-02-01

Expected to finish

2009-07-01

Last updated by the study team

2008-03-10

Who can join

Age: 18 and older, up to 35. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Active Duty
• Aged 18-35
• New episode of low back pain (LBP) or a reoccurence of a past episode of low back pain

You may not qualify if…

• 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?"

Where it is running

• Center for Integrative Medicine (CIM) at William Beaumont Army Medical Center; Soldier Family Medical Clinic (SFMC) at Ft. Bliss, TX — El Paso, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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