Chronic Low Back Pain and Primary Health Care
|ClinicalTrials.gov Identifier: NCT01147120|
Recruitment Status : Completed
First Posted : June 22, 2010
Last Update Posted : June 4, 2014
|Condition or disease||Intervention/treatment||Phase|
|Low Back Pain||Behavioral: Progressive Muscle Relaxation (PMR) Procedure: Clinical Massage Therapy (CMT)||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||138 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||CAM Referral and Outcomes: Chronic Low Back Pain in Urban and Rural Primary Care|
|Study Start Date :||September 2009|
|Actual Primary Completion Date :||July 2013|
|Actual Study Completion Date :||July 2013|
|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.
- Oswestry Disability Index (ODI) [ Time Frame: Baseline, 12 Weeks, and 24 Weeks ]Survey completed at Baseline, 12 Weeks, and 24 Weeks
- Short Form 36 (SF-36) [ Time Frame: Baseline, 12 Weeks, and 24 Weeks ]Health related quality of life survey
- Faces Pain Scale - Revised (FPS-R) [ Time Frame: Baseline, 12 Weeks, and 24 Weeks ]Survey
- Pain Medication Questionnaire (PMQ) - subset [ Time Frame: Baseline, 12 Weeks, and 24 Weeks ]Survey
- Expectations for and Satisfaction with Therapies [ Time Frame: Baseline and 12 Weeks ]Survey
- Tampa Scale of Kinesiophobia (TSK) - Subset [ Time Frame: Baseline, 12 Weeks, and 24 Weeks ]Survey
- Patient Perceptions of CAM Therapy [ Time Frame: Baseline, 12 Weeks, and 24 Weeks ]Survey
- Physician Perceptions of CAM Therapy [ Time Frame: Baseline ]Survey
- Physician Point-of-Care Card [ Time Frame: 4 weeks per practice (Identify and screen for possible patients) ]CLBP visit description and reasons to recommend patients for this therapy study.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01147120
|United States, Kentucky|
|Department of Family and Community Medicine; University of Kentucky|
|Lexington, Kentucky, United States, 40536|
|Principal Investigator:||William G Elder, PhD||University of Kentucky|