This pilot study will determine the feasibility of enrolling participants from different populations for a larger study of low back pain (LBP) treatment. In addition, this study will assess the effectiveness of data collection instruments and procedures as well as utilize feedback from participants to refine a future study.

Condition	Intervention
Low Back Pain	Behavior: Integrative care for low back pain  Behavior: Conventional treatment for low back pain

Further Study Details: 

Primary Outcomes: LBP symptoms
Secondary Outcomes: Feasibility of enrolling LBP patients from different populations; effectiveness of data collection instruments and procedures
Expected Total Enrollment:  60

Back pain is one of the most common health problems in the United States, afflicting up to 50% of adults each year. Back pain is the leading cause of visits to orthopedic surgeons and the second leading cause of visits to general practitioners. In the United States, the estimated annual cost of back pain, including medical costs and lost productivity, is between $50 and $100 billion. Unfortunately, conventional medical care has been largely ineffective in treating back pain of most people. An increasing number of people with back pain, particularly with LBP, are seeking relief from unconventional sources such as chiropractors and massage therapies. Although complementary and alternative medicine (CAM) therapies are being used to treat LBP, their effectiveness has not been thoroughly examined. Even less is known about the effectiveness of combining conventional medical care with CAM therapies to provide “integrative care.” This pilot study will recruit participants from three different patient populations to determine the effectiveness of integrative care in treating LBP symptoms.

This study will last 26 weeks and will comprise three participant populations: patients at an occupational health clinic, primary care patients at a medical clinic, and workers'''' compensation patients at the same medical clinic. At study start, participants will be interviewed about the care they have already received for LBP, any activities limited by their LBP, their attitudes toward CAM back pain treatments, job satisfaction, social support in the workplace, and medical history. Participants will also complete a self-report pain scale and a disability questionnaire. Participants will then be randomly assigned to either receive treatment for their LBP at an Integrative Care Center or continue to receive usual care provided by their medical or occupational health clinic.

Participants assigned to receive integrative care will be evaluated by both a medical doctor and a CAM clinician immediately after being interviewed. Following the evaluation, the two clinicians will meet and develop a treatment plan, which will include conventional medical care and some form of CAM such as acupuncture, chiropractic, exercise, massage, mind-body therapy, or nutritional counseling. Treatments will occur either once or twice weekly for the 12-week duration of treatment; clinicians may revise treatment plans during the study. LBP symptoms will be assessed through phone interviews at Weeks 2, 5, 12, and 26.

Ages Eligible for Study:  18 Years   -   70 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Low back pain beginning 3 to 6 weeks prior to study entry
• Patient of Partners Occupational Health Center or Harvard Vanguard Medical Associates (HVMA)
• Able to speak and understand English
• Willing and able to comply with all study requirements

Exclusion Criteria:

• History of back surgery within 3 years prior to study entry
• History of vertebral fracture or dislocation
• Progressive or severe neurological symptoms such as loss of bowel or bladder control, numbness in groin or rectal area, or extreme leg weakness
• Severe inflammation of the vertebrae, stiffening of the joints and ligaments, or scoliosis
• Pacemaker or implanted defibrillator
• Underlying systemic or visceral disease which might be causing back pain
• Osteoporosis
• Cancer within 5 years prior to study entry. Participants with non-melanoma skin cancer are not excluded.
• Unexplained weight loss or recent unexplained fever
• Bleeding disorder or current use of anticoagulant medication
• Any disabling medical condition
• Major organ transplantation
• Current use of systemic corticosteroids
• Current use of immunosuppressive medications
• Current use of intravenous drugs
• Pregnancy

Please refer to this study by ClinicalTrials.gov identifier  NCT00118859

Andrea Hrbek      617-384-8566    andrea_hrbek@hms.harvard.edu

Massachusetts
      Osher Institute, Harvard Medical School, Boston,  Massachusetts,  02215,  United States; Recruiting

Study chairs or principal investigators

David Eisenberg, PhD,  Principal Investigator,  Harvard Medical School   

Study ID Numbers:  RO1-AT00905; ICC
Record last reviewed:  July 2005
Last Updated:  July 18, 2005
Record first received:  July 11, 2005
ClinicalTrials.gov Identifier:  NCT00118859
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-07-26