Chronic Low Back Pain and Primary Health Care

NCT01147120 | Completed DMC

• 1 other identifier: 1R21AT004544-01A2
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (3)

• Oswestry Disability Index (ODI)

  Survey completed at Baseline, 12 Weeks, and 24 Weeks

  Baseline, 12 Weeks, and 24 Weeks

• Short Form 36 (SF-36)

  Health related quality of life survey

  Baseline, 12 Weeks, and 24 Weeks

• Faces Pain Scale - Revised (FPS-R)

  Survey

  Baseline, 12 Weeks, and 24 Weeks

Secondary Outcomes (6)

• Pain Medication Questionnaire (PMQ) - subset

  Baseline, 12 Weeks, and 24 Weeks

• Expectations for and Satisfaction with Therapies

  Baseline and 12 Weeks

• Tampa Scale of Kinesiophobia (TSK) - Subset

  Baseline, 12 Weeks, and 24 Weeks

• Patient Perceptions of CAM Therapy

  Baseline, 12 Weeks, and 24 Weeks

• Physician Perceptions of CAM Therapy

  Baseline

Study Arms (2)

Progressive Muscle Relaxation

ACTIVE COMPARATOR

Behavioral: Progressive Muscle Relaxation (PMR)

Clinical Massage Therapy

ACTIVE COMPARATOR

Procedure: Clinical Massage Therapy (CMT)

Interventions

Progressive Muscle Relaxation (PMR) BEHAVIORAL

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.

Progressive Muscle Relaxation

Clinical Massage Therapy (CMT) PROCEDURE

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.

Clinical Massage Therapy

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• William G Elder JR: lead
• National Institutes of Health (NIH): collaborator
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Department of Family and Community Medicine; University of Kentucky

Lexington, Kentucky, 40536, United States

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Autogenic Training

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hypnosis; Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• William G Elder, PhD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 30, 2010
• First Posted: June 22, 2010
• Study Start: September 1, 2009
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: June 4, 2014

Record last verified: 2014-06

Locations

US (1)