Clinical trial NCT00561652: Education/Exercise and Chiropractic for Chronic Back Pain
Official title: Education/Exercise and Chiropractic for Chronic Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: Low back pain
Chiropractic
Exercise
Veterans
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: Northwestern Health Sciences University
First posted: 2007-11-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Chronic low back pain (LBP) is associated with poor health, lower quality of life, high costs, and is highly prevalent in veterans. Both chiropractic care and exercise have modestly reduced pain and/or improved function in randomized controlled trials (RCTs) of patients with chronic LBP. However, effects may not apply similarly to all populations. For example, there are no RCT data on chiropractic care for older (age \>70) patients with chronic LBP, though with increased spinal arthritis, comorbidities and frailty, such patients may require modified chiropractic techniques and likely differ in response to chiropractic treatment. While a recent systematic review of RCTs predicted that a home exercise program that was individualized, high-dose, therapist-directed, and incorporated stretching and strengthening would be a meaningful treatment for chronic LBP, it also could provide a robust comparison group for other chronic LBP treatments. The combination of such a regimen and chiropractic care is predicted to have additive benefits for chronic LBP but this premise hasn't been directly tested. To further our aim of improving the health of chronic LBP patients, we plan an RCT in veterans with chronic LBP, to compare the effectiveness, cost-effectiveness and cost-utility of a tailored education/exercise (E/E) intervention alone vs. E/E plus chiropractic care. The demographics and medical complexity of the veteran population provide a great opportunity to test the appropriate role of chiropractic care for such patients with chronic LBP and to advance chronic LBP research and clinicalcare.

Subjects will be recruited primarily from patients attending Minneapolis VAMC clinics with complaints of chronic LBP. Thirty eligible veterans will be randomized to E/E alone vs. E/E plus chiropractic care. All participants will receive E/E instruction in four 1-hr individual sessions over 8 weeks, including an individually designed, high dose, therapist-directed home exercise program. Chiropractic care will be delivered by chiropractors and follow standard protocols, with up to 12 sessions over 12 weeks. Participants randomized to E/E alone also will attend 10 weekly "time and attention" visits so that their contact with providers is comparable to that received by participants who also receive chiropractic care. Each "time and attention" session involved a 5 minute exam, 5 minutes of hot pack application to the low back, and 5 minutes of light massage to the low back. During these visits, participants did not receive SMT, mobilization or other active chiropractic treatment. The recruitment goal is to generate the potential to randomize 6-10 participants/month. Recruitment feasibility will be assessed by tracking the number of patients who make initial inquiries, undergo screening and in-clinic evaluation, and are randomized. Further, reasons for nonparticipation and disqualification will be examined and described. Participant adherence to interventions will be defined as completing \>3 of 4 education sessions, \>20 hrs of home exercise, and \>80% of recommended chiropractic visits or nonchiropractic follow-up exam/interviews. Adherence with clinic visits will be assessed with provider treatment logs. Home exercise compliance will be tracked by questionnaire. Participant adherence to data collection will be defined as \>90% follow-up rates at each time point and assessed by tracking questionnaire completion rates. Descriptive data for the distributions of the primary and main secondary efficacy outcome measures will be used to calculate sample size and generate power tables for the full-scale trial.

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

Primary outcomes:
measure: Participant Adherence With Education + Exercise Visits
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
measure: Participant Adherence With Chiropractic Visits
timeFrame: 12 weeks
measure: Participant Adherence With "Time and Attention" Visits
timeFrame: 12 weeks
measure: Participant Adherence With Prescribed Home Exercise
timeFrame: 12 weeks
measure: Participant Adherence With Week 6 Follow-up Questionnaire
timeFrame: 6 weeks
measure: Participant Adherence With Week 12 Follow-up Questionnaire
timeFrame: 12 weeks
measure: Participant Adherence With Week 26 Follow-up Questionnaire
timeFrame: 26 weeks
Locations:
city: Minneapolis
country: United States
facility: Minneapolis VA Health Care System
state: Minnesota
Study officials:
affiliation: Minneapolis Veterans Affairs Medical Center
name: Howard A. Fink, MD MPH
role: PRINCIPAL_INVESTIGATOR
References: