- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01147120
Chronic Low Back Pain and Primary Health Care
CAM Referral and Outcomes: Chronic Low Back Pain in Urban and Rural Primary Care
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Kentucky
-
Lexington, Kentucky, United States, 40536
- Department of Family and Community Medicine; University of Kentucky
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Progressive Muscle Relaxation
|
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
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Oswestry Disability Index (ODI)
Time Frame: Baseline, 12 Weeks, and 24 Weeks
|
Survey completed at Baseline, 12 Weeks, and 24 Weeks
|
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
|
Baseline, 12 Weeks, and 24 Weeks
|
Faces Pain Scale - Revised (FPS-R)
Time Frame: Baseline, 12 Weeks, and 24 Weeks
|
Survey
|
Baseline, 12 Weeks, and 24 Weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain Medication Questionnaire (PMQ) - subset
Time Frame: Baseline, 12 Weeks, and 24 Weeks
|
Survey
|
Baseline, 12 Weeks, and 24 Weeks
|
Expectations for and Satisfaction with Therapies
Time Frame: Baseline and 12 Weeks
|
Survey
|
Baseline and 12 Weeks
|
Tampa Scale of Kinesiophobia (TSK) - Subset
Time Frame: Baseline, 12 Weeks, and 24 Weeks
|
Survey
|
Baseline, 12 Weeks, and 24 Weeks
|
Patient Perceptions of CAM Therapy
Time Frame: Baseline, 12 Weeks, and 24 Weeks
|
Survey
|
Baseline, 12 Weeks, and 24 Weeks
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Physician Perceptions of CAM Therapy
Time Frame: Baseline
|
Survey
|
Baseline
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Physician Point-of-Care Card
Time Frame: 4 weeks per practice (Identify and screen for possible patients)
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CLBP visit description and reasons to recommend patients for this therapy study.
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4 weeks per practice (Identify and screen for possible patients)
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: William G Elder, PhD, University of Kentucky
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1R21AT004544-01A2 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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