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Project Title: Effectiveness Research — CAM Interventions and Chronic Back Pain

Council Date: September 12, 2008

Program Officer:
Partap S. Khalsa, D.C., Ph.D.
Phone: 301-496-4792
Email: khalsap@mail.nih.gov

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Overall Goals

The focus of this proposed program is to promote research that will rigorously examine the contribution of CAM interventions, as employed in complementary "real-world" practice settings, to the treatment of chronic back pain.

Background

• The Scope and Burden of Chronic Pain: Chronic pain and the morbidity and disability associated with it are major health problems around the world. In spite of huge expenditures on care (e.g., annual U.S. expenditures for back pain alone are estimated at $50B to $100B annually), available treatment options and approaches are less than fully satisfactory by any measure. Several recent reports underscore the considerable scope and importance of chronic pain, and the potential value of broad research approaches.
• Back Pain and the Role of CAM Interventions in Its Management
• According to the most recent NHIS data, pain far exceeds any other health condition as a reason for CAM use among adults. For example, pain is the predominant symptom of 4 of the top 5 conditions for which CAM was used.
• "Back pain," cited by 17.1% of NHIS CAM users, topped this list and was cited 3 times more frequently than any other condition.
• A report by the Agency for Healthcare Research and Quality (AHRQ) on utilization of CAM therapies for back pain found that the three most utilized interventions were spinal manipulation, massage, and acupuncture (in that order).
• A reasonable body of evidence suggests that some CAM interventions may be useful additions to the armamentarium of options for care for some chronic painful conditions exists. For example, the American College of Physicians and the American Pain Society recently issued guidelines for treatment of back pain. These guidelines identify several CAM interventions that should be considered by physicians when treating patients.
• Defining the Research Need: The evidence base for such interventions is limited, however. For instance, the ACP/APS guidelines are based to a great extent on comparisons of CAM interventions to sham or placebo or wait list controls in highly restrictive clinical trial settings (efficacy trials), not as these therapies might be practiced in the "real world." The absence of direct comparisons between various CAM therapies and best conventional care is another limitation of the ACP/APS back pain guidelines. Thus, there is a compelling need for effectiveness research on potentially useful CAM interventions, especially as they are administered and utilized in real-world settings, across a broad range of outcome measures meaningful to patients and their health care providers.

Purpose of the Proposed Initiative

The overarching goal of this proposed program is to promote research that will rigorously examine the contribution of highly promising CAM interventions, as they are employed in complementary "real-world" practice settings, to the treatment of chronic pain conditions. The initial line of work supported by the program will focus on back pain. Responsive research might employ a number approaches including effectiveness clinical trials or observational studies. Outcome measures should include conventional clinical endpoints commonly used to assess pain therapies as well as other measures of effectiveness that are meaningful to patients and/or result in improved health or well-being (e.g., reduced utilization of narcotic analgesics and other more expensive or problematic treatment options, patient satisfaction, personal preferences, or functional abilities).

In the context of such studies, ancillary research which seeks to develop patient-reported or patient-oriented outcome measures for health-related quality of life would be encouraged. Studies of highly promising interventions with a reasonable evidence base of efficacy would be encouraged. Specific research proposals would originate with the investigative community.

In pursuing this concept, NCCAM will help to strengthen the quality of the evidence base regarding CAM approaches to alleviation of chronic back pain. In the process we will also explore the feasibility of extending this line of research into other chronic painful conditions. Finally, this program will serve as an important focal point for NIH efforts to coordinate interdisciplinary pain research.