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Chronic Low Back Pain and Primary Health Care

CompletedNot applicableNCT01147120
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study details

Official title
CAM Referral and Outcomes: Chronic Low Back Pain in Urban and Rural Primary Care
Conditions
Interventions
  • Behavioral: Progressive Muscle Relaxation (PMR)
  • Procedure: Clinical Massage Therapy (CMT)
Sponsor
William G Elder JR
Collaborators
National Institutes of Health (NIH); National Center for Complementary and Integrative Health (NCCIH)
Organization
University of Kentucky
Start date
2009-09
Primary completion
2013-07
Sex
All
Age range
from 21 Years
Results posted
No results posted in this snapshot
Countries
United States
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01147120