Clinical trial NCT01147120: Chronic Low Back Pain and Primary Health Care
Official title: CAM Referral and Outcomes: Chronic Low Back Pain in Urban and Rural Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2010-06-22
Enrollment: 138
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Kentucky ranks 2nd in disability among states, with chronic low back pain (CLBP) as a major disability, especially in the investigators rural areas. Kentucky and U.S. health care providers need alternative and effective treatments. Following NCCAM strategic research recommendations, this study will investigate health services outcomes of complementary and alternative medicine (CAM) therapies in an existing primary care practice-based research network (PBRN). The Patients with CLBP are often willing to try therapeutic options outside the conventional medical spectrum. Massage and relaxation therapies have demonstrated fairly good efficacy in controlled trials but their effectiveness in the "real world" of primary care is only beginning to be evaluated. The long-term goal of the proposed project builds on the foundation of these two established therapies to improve treatment of chronic low back pain (CLBP) in primary care practices. Two alternative (CAM) therapies, progressive muscle relaxation (PMR) and clinical massage therapy (CMT), will be studied. The short-term objectives of the proposed project are to: (1) examine outcomes of CAM for patients with CLBP referred from primary care practices, and (2) better understand physician decision-making to recommend CAM therapy for CLBP. Specific Aim 1 will evaluate improvement in health-related outcomes for patients with CLBP when referred to PMR or CMT from primary care. Specific Aim 2 will explore selected factors in primary care physicians' decisions to recommend CAM therapy to these patients. The proposed study is unique in that it addresses "real life" clinical situations and decision-making in both urban and rural clinical practices within an existing PBRN. Should such CAM referral prove successful for ameliorating CLBP, it would provide relatively low cost, non-addictive treatment options for inclusion in the repertoire of primary care physicians.

Detailed description: The proposed study will investigate health related outcomes of two CAM treatments recommended by primary care physicians for CLBP, and explore selected elements in the decision process to recommend or not recommend one of two CAM treatments.

Patients and primary care physicians (PCPs) will participate from metropolitan and nonmetropolitan central Kentucky practices of the Kentucky Ambulatory Network (KAN), Kentucky's statewide primary care practice-based research network (PBRN). Each practice will have a patient participant enrollment period of four weeks. Patients with CLBP who have a visit during the enrollment period in a practice may be eligible to participate in the study, and participating PCPs will be invited to recommend as many eligible patients as they feel comfortable. During patient visits, the PCP may offer a recommendation to the patient to receive PMR or CMT. Patients who agree will be recruited by the KAN/CAM project team staff. Patients who enroll in the CAM recommendation study will receive a 12-week course of PMR or CMT treatments. Outcomes will be measured at three time points: baseline, 12 weeks, and 24 weeks.

Eligibility criteria: Inclusion Criteria:

* Have a visit with the physician during the 4-week study referral period for that practice
* Be 21 years of age or older on the date of the visit
* According to the physician, currently have CLBP
* Have been a patient in the practice for at least 3 months
* Have a life expectancy of 6 months or more

Exclusion Criteria:

* Not have a current or past history of psychosis
* Not be pregnant

Primary outcomes:
measure: Oswestry Disability Index (ODI)
timeFrame: Baseline, 12 Weeks, and 24 Weeks
measure: Short Form 36 (SF-36)
timeFrame: Baseline, 12 Weeks, and 24 Weeks
measure: Faces Pain Scale - Revised (FPS-R)
timeFrame: Baseline, 12 Weeks, and 24 Weeks
Secondary outcomes:
measure: Pain Medication Questionnaire (PMQ) - subset
timeFrame: Baseline, 12 Weeks, and 24 Weeks
measure: Expectations for and Satisfaction with Therapies
timeFrame: Baseline and 12 Weeks
measure: Tampa Scale of Kinesiophobia (TSK) - Subset
timeFrame: Baseline, 12 Weeks, and 24 Weeks
measure: Patient Perceptions of CAM Therapy
timeFrame: Baseline, 12 Weeks, and 24 Weeks
measure: Physician Perceptions of CAM Therapy
timeFrame: Baseline
measure: Physician Point-of-Care Card
timeFrame: 4 weeks per practice (Identify and screen for possible patients)
Other outcomes:
Locations:
city: Lexington
country: United States
facility: Department of Family and Community Medicine; University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: William G Elder, PhD
role: PRINCIPAL_INVESTIGATOR
References: