Education/Exercise and Chiropractic for Chronic Back Pain

NCT ID: NCT00561652

Last Updated: 2015-02-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2009-07-31

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.

Conditions

Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Education + exercise

Education was provided in four, 1-hour sessions to improve patients' understanding of their back problem, reduce unwarranted concern about serious outcomes, \& empower them to maintain normal activities \& reduce risk of future back problems. Patients were taught that recovery depends on moving \& restoring normal function \& fitness. Patients were shown stretching \& strengthening exercises to perform daily at home to enhance mobility \& increase trunk endurance while minimizing spinal load. At follow-up, therapists reviewed exercise form \& adherence. Participants allocated to no chiropractic care also were scheduled for 10 weekly 10-15 minute sessions to equalize provider attention vs. the group also receiving chiropractic care \& not to provide education, exercise instruction, or therapy.

Group Type: ACTIVE_COMPARATOR

Education & Exercise

Intervention Type: BEHAVIORAL

Education \& Exercise

Education + exercise + chiropractic

In addition to education \& exercise, all participants in this arm will be assigned chiropractic treatment. A minimum of 4 \& up to 12 treatments will be provided over 6 weeks, based on patient response (i.e. treatments stopped if symptoms resolve). Each treatment visit will last 10-20 minutes. After 6 weeks, if the treating chiropractor determined that the patient's LBP was continuing to improve but hadn't reached therapy goals defined at baseline, the patient could receive up to 12 additional treatments over the next 6 weeks. Chiropractic treatment was delivered following standardized protocols. Treatment consisted of manual therapies, including SMT and mobilization techniques, with the assistance of light soft tissue techniques as indicated to facilitate the SMT.

Group Type: EXPERIMENTAL

Education & Exercise

Intervention Type: BEHAVIORAL

Education \& Exercise

Chiropractic treatment (plus Education & Exercise)

Intervention Type: PROCEDURE

Chiropractic treatment (plus Education \& Exercise)

Interventions

Education & Exercise

Education \& Exercise

Intervention Type: BEHAVIORAL

Chiropractic treatment (plus Education & Exercise)

Chiropractic treatment (plus Education \& Exercise)

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Northwestern Health Sciences University

OTHER

Sponsor Role: collaborator

US Department of Veterans Affairs

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Howard A. Fink, MD MPH

Role: PRINCIPAL_INVESTIGATOR

Minneapolis Veterans Affairs Medical Center

Locations

Minneapolis VA Health Care System

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

B5027-R

Identifier Type: -

Identifier Source: org_study_id