N/A
N=30
Education/Exercise and Chiropractic for Chronic Back Pain
Low Back Pain
Bottom Line
View on ClinicalTrials.gov: NCT00561652 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Feb 2015
Primary outcome: Primary: Participant Adherence With Education + Exercise Visits — 9; 19 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Education & Exercise (Behavioral); Chiropractic treatment (plus Education & Exercise) (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- US Department of Veterans Affairs
- Primary completion
- Jul 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participant Adherence With Education + Exercise Visits |
9; 19 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00561652). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.