Chronic Low Back Pain and Primary Health Care

This study has been completed.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
William G Elder JR, University of Kentucky
ClinicalTrials.gov Identifier:
NCT01147120
First received: March 30, 2010
Last updated: June 3, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Low Back Pain
Behavioral: Progressive Muscle Relaxation (PMR)
Procedure: Clinical Massage Therapy (CMT)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: CAM Referral and Outcomes: Chronic Low Back Pain in Urban and Rural Primary Care

Resource links provided by NLM:


Further study details as provided by University of Kentucky:

Primary Outcome Measures:
  • Oswestry Disability Index (ODI) [ Time Frame: Baseline, 12 Weeks, and 24 Weeks ] [ Designated as safety issue: No ]
    Survey completed at Baseline, 12 Weeks, and 24 Weeks

  • Short Form 36 (SF-36) [ Time Frame: Baseline, 12 Weeks, and 24 Weeks ] [ Designated as safety issue: No ]
    Health related quality of life survey

  • Faces Pain Scale - Revised (FPS-R) [ Time Frame: Baseline, 12 Weeks, and 24 Weeks ] [ Designated as safety issue: No ]
    Survey


Secondary Outcome Measures:
  • Pain Medication Questionnaire (PMQ) - subset [ Time Frame: Baseline, 12 Weeks, and 24 Weeks ] [ Designated as safety issue: No ]
    Survey

  • Expectations for and Satisfaction with Therapies [ Time Frame: Baseline and 12 Weeks ] [ Designated as safety issue: No ]
    Survey

  • Tampa Scale of Kinesiophobia (TSK) - Subset [ Time Frame: Baseline, 12 Weeks, and 24 Weeks ] [ Designated as safety issue: No ]
    Survey

  • Patient Perceptions of CAM Therapy [ Time Frame: Baseline, 12 Weeks, and 24 Weeks ] [ Designated as safety issue: No ]
    Survey

  • Physician Perceptions of CAM Therapy [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Survey

  • Physician Point-of-Care Card [ Time Frame: 4 weeks per practice (Identify and screen for possible patients) ] [ Designated as safety issue: No ]
    CLBP visit description and reasons to recommend patients for this therapy study.


Enrollment: 138
Study Start Date: September 2009
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Progressive Muscle Relaxation Behavioral: Progressive Muscle Relaxation (PMR)
Progressive Muscle Relaxation (PMR) will be recorded on PDAs integrated with EMA software and offered to patients who will be instructed in the techniques and PDA use by study coordinators. They will be instructed to practice 25 minutes/day the first two weeks, 35 minutes/day weeks 3 and 4, and 45 minutes/day weeks 5 through 12. These time periods (25/35/45 minute) were selected to allow a more gradual acclimation to PMR.
Active Comparator: Clinical Massage Therapy Procedure: Clinical Massage Therapy (CMT)
PCPs will have the opportunity to refer patients with CLBP to local Licensed Massage Therapists (LMTs) to receive up to 10 clinical massage sessions over a 12-week period. CMT will be provided at no cost to the patients. At their first two sessions, the LMT will evaluate the patient and, with the patient, estimate the number of sessions and determine treatment goals. Based on previous literature, 10 sessions are anticipated over an average 12-week period. However, treatment will vary depending on assessment and progress. At the end of the treatment period, the patients will receive a list of all participating LMTs to facilitate patients' continued or future participation in massage therapy.

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

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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: NCT01147120

Locations
United States, Kentucky
Department of Family and Community Medicine; University of Kentucky
Lexington, Kentucky, United States, 40536
Sponsors and Collaborators
William G Elder JR
Investigators
Principal Investigator: William G Elder, PhD University of Kentucky
  More Information

No publications provided

Responsible Party: William G Elder JR, Principal Investigator, University of Kentucky
ClinicalTrials.gov Identifier: NCT01147120     History of Changes
Other Study ID Numbers: 1R21AT004544-01A2, 1R21AT004544-01A2
Study First Received: March 30, 2010
Last Updated: June 3, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 18, 2014