Education/Exercise and Chiropractic for Chronic Back Pain

Completed · Not applicable

Conditions studied: Low Back Pain

In brief

As a needed first step prior to a planned full-scale RCT, in order to assess the feasibility of the RCT and refine its design and protocols, we will perform a pilot study with the following objectives:1.To assess whether enough veterans with chronic LBP can be identified, meet eligibility criteria and be randomized to demonstrate that recruitment for a planned full-scale RCT is feasible. 2.To assess whether veterans with chronic LBP will adhere to protocol interventions per study protocol. 3.To assess whether veterans with chronic LBP will complete data collection per study protocol. 4.To obtain estimates of effect sizes and the corresponding standard errors of the primary efficacy outcome measures to estimate the required sample size of a planned full-scale RCT.

Key facts

Study ID

NCT00561652

Run by

US Department of Veterans Affairs

People needed

30

Starts

2008-04-01

Expected to finish

2009-07-01

Last updated by the study team

2015-02-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Veterans enrolled to receive VA medical care
• Current low back pain episode present > 6 weeks.
• LBP pain score > 3 on scale of 0-10.
• LBP classified using the Quebec Task Force (QTF) system as types 1-4 respectively, patients with LBP, stiffness or tenderness, without radiation; with radiation proximal to knee; with radiation distal to knee; or with radiation and >2 abnormal neurological exam findings.
• No change in past month in prescription medications affecting musculoskeletal pain.

You may not qualify if…

• Low back pain classified as QTF type 5-11
• Progressive neurologic deficits due to nerve root or spinal cord compression, including symptoms/signs of cauda equina syndrome.
• Previous lumbar spine surgery, by history and/or screening spine radiograph.
• Acute vertebral fracture, by history and spine radiograph
• Self-reported ongoing LBP treatment by other healthcare providers other than stable prescription medications affecting musculoskeletal pain.
• Infectious and noninfectious inflammatory destructive spine tissue changes, by spine radiograph
• Self-reported pending/current litigation pertaining to back pain, including workers compensation claims; or pending evaluation of VA service connected rating related to back pain.
• Clinically significant chronic inflammatory spinal arthritis
• Self-reported pregnancy
• Self-reported current substance abuse
• History of bleeding disorder
• Known arterial aneurysm near LBP area
• Possible/confirmed spinal/vertebral infection, by history and spine radiograph
• Primary or metastatic vertebral malignancy, by history and spine radiograph

Where it is running

• Minneapolis VA Health Care System — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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