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Trial record 2 of 8 for:    chiropractic and exercise seniors low back pain

Education/Exercise and Chiropractic for Chronic Back Pain

This study has been completed.
Sponsor:
Collaborator:
Northwestern Health Sciences University
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00561652
First received: November 19, 2007
Last updated: September 23, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention
Low Back Pain
Behavioral: Education & Exercise
Procedure: Chiropractic treatment (plus Education & Exercise)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Education/Exercise and Chiropractic for Chronic Back Pain

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Feasibility of recruitment for future full-scale trial [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Participant compliance with education, exercise & chiropractic treatment protocol; Participant compliance with data collection; Estimation of variation in response in pain severity and disability for calculation of sample size for full-scale trial [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: April 2008
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm 1
Education and Exercise
Behavioral: Education & Exercise
Education & Exercise
Experimental: Arm 2
Chiropractic treatment (plus Education & Exercise)
Behavioral: Education & Exercise
Education & Exercise
Procedure: Chiropractic treatment (plus Education & Exercise)
Chiropractic treatment (plus Education & Exercise)

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 will attend 10 weekly exam/interview sessions so that their contact with providers is comparable to that received by participants who also receive chiropractic care. 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00561652

Locations
United States, Minnesota
Minneapolis VA Health Care System
Minneapolis, Minnesota, United States, 55417
Sponsors and Collaborators
Northwestern Health Sciences University
Investigators
Principal Investigator: Howard A. Fink, MD MPH Minneapolis VA Health Care System
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00561652     History of Changes
Other Study ID Numbers: B5027-R
Study First Received: November 19, 2007
Last Updated: September 23, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Low back pain
Chiropractic
Exercise
Veterans

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on November 20, 2014