GRANTS AWARDED BY FCER/NCMIC, NOVEMBER 1996:

1. 96-03-12

David M. Eisenberg, M.D.

Harvard Medical School / Beth Israel Hospital

Should Patients with Acute Low Back Pain be Offered Chiropractic Acupuncture and Massage Therapy as "Expanded Benefits"? A Randomized Trial Involving a Managed Care Population

$100,000

The Principal Investigator proposes a pilot study which would evaluate the feasibility of a full study to determine the outcomes, satisfaction, and cost-effectiveness of providing either standard care or "expanded benefits [EB]" care to patients of a large managed care organization. The pilot study would enroll 60 low-back pain patients into the trial, 20 randomized into the standard care group and 40 into the EB group. The EB group would be given the choice of regular care, chiropractic care, acupuncture, or massage therapy for their low back pain problem.

Subjects randomized into the EB arm would receive up to 10 treatments [2 per week] over a 5-week period, the treatments typically being available within 48 hours after randomization and provided by licensed chiropractors, acupuncturists and massage therapists practicing in the study subjects' geographic vicinity. Symptom relief, functional status, restricted activity days, use of health care, and patient and provider satisfaction will be assessed at 2, 5, and 12 weeks after initiation of treatment.

It is hypothesized that patients offered the EB will be more satisfied with their care. The impact on clinical outcomes and overall costs is less predictable, but suspected to favor chiropractic. The results of this study will provide patients, health care providers, managed care systems and insurers with key information on patients' preferences, willingness to comply with commonly used treatments for low back pain, and the costs associated with each treatment. The study represents a unique collaboration between a managed care organization and an academic research center supported by the NIH's Office of Complementary and Alternative Medicine.

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GRANTS AWARDED BY FCER/NCMIC, SEPTEMBER 1996:

1. 96-03-09

Meridel I. Gatterman, M.A., D.C.

New York Chiropractic College

Outlines for Utilization of Chiropractic Procedures in the Treatment of Low-Back Pain

$48,600

This proposal seeks to develop guidelines for the standard application of common chiropractic techniques for the treatment of low-back pain. It will seek to do so by progressing through the following steps:

a. Conduct a literature search to screen for appropriate articles from the chiropractic, osteopathic, and medical literature pertaining to manipulative techniques in managing low-back pain;

b. Appraise the articles retrieved, using forms used by the Quebec Task Force and assessment criteria [procedure ratings, quality of evidence, strength of ratings, and safety and effectiveness] following the ratings used in the Mercy Guidelines; and

c. Convene expert panels to perform nominal and delphi group consensus exercises to rate recommendations.

The process is expected to take one year, with the final draft of the guidelines to be submitted for publication. In addition to promoting inclusion of chiropractic procedures in the changing health care system, it should reduce inappropriate care indications for trials of alternative chiropractic techniques, utilize health care resources more effectively, and offer standardization of care in the patient's interest.

2. 96-03-14

Jeff Balon, D.C., M.D.

A Randomized Controlled Trial of Chiropractic Care for Chronic Childhood Asthma

$34,350

This proposal requests a 6-month extension of a randomized controlled clinical trial which compares standard chiropractic care to sham manipulation for 100 children aged 8-16 years with mild to severe chronic asthma who are on a stable medical regimen. A total of 28 treatments are applied over a 4-month period after a baseline period of 3-4 weeks. The primary outcome measure is peak expiratory flow rate [PEFR], while secondary outcomes are spirometry results, symptoms, medication use, inflammatory reaction, and hospital or emergency department visits. In its study of asthma, this proposal is addressed to the most common chronic disease of childhood.

Dr. Balon's research is built upon the results of published case reports and retrospective chart reviews, using a rationale for care that is hypothesized to exercise its effects through reflex neurological pathways and/or biomechanical effects. It is proposed that chiropractic care may lessen medication needs in pediatric asthmatics and improve their overall quality of life.

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GRANTS AWARDED BY FCER/NCMIC, JULY 1996:

1. Deb Callahan

Foundation for Chiropractic Education and Research

Chiropractic Patient Satisfaction with Treatment of Conditions other than Low Back Pain

$15,000

Patient satisfaction continues to be an important measure of treatment efficacy. A number of studies have been completed on chiropractic patient satisfaction, the majority of which have focused on satisfaction relating to the treatment of low back pain. This monograph will use data compiled from two previously funded NCMIC reports to discuss patient satisfaction with chiropractic treatment of conditions other than low back pain.

To conduct this study, the project team will 1) manipulate the data variables from the two previous studies to a) illustrate what is anticipated to be a high degree of patient satisfaction with other than low back pain treatment, b) reiterate the use of chiropractic services for more than low back pain, and 2) draw on the existing literature addressed to patient satisfaction and chiropractic utilization data.

As a sidebar to the above, the project team will implement a small-scale satisfaction survey of chiropractic patients who have been specifically identified as 1) using chiropractic care for other than low back pain, and/or 2) referred to their chiropractor for services that are considered primary care in nature [nutritional, exercise counseling; general health screening, etc]. The purpose of this would be to collect some subjective data that would be used to enhance the commentary in the monograph.

The result of this research effort will be the production of a monograph that demonstrates patient satisfaction with treatment for other than low back pain conditions.

2. Gerald Celente

Trends Research Institute

Trend Intelligence Report for the Chiropractic Profession

$120,000

The Trends Research Institute, founded in 1980, has utilized its 25-member interdisciplinary task force in providing early forecasts of the pitfalls and opportunities in various marketplaces, whether economic or political. It is to prepare a proprietary report that would forecast newly emerging trends affecting the personal health of the general population, identifying specific health care services and products needed to satisfy the public demand and which are not currently being met. In so doing, it will identify how chiropractors can proactively position themselves as primary providers under these circumstances. At the same time, it hopes to expand the public's current narrow perception of chiropractic's contributions to health care and thus provide chiropractors with strategies on how to expand their patient base.

3. Brian Nook, D.C.

Atlanta Sports Chiropractic Committee

"Athletic Data Collection and Analysis"

$5,000

This project extends the NCMIC grant originally awarded to Dr. Nook in September 1995, and will document the performance and extent of chiropractic management at the 1996 Olympic Games in Atlanta. A group of chiropractic doctors are to provide services to the Atlanta Sports Chiropractic Committee; their data should stimulate further research and clinical care regarding chiropractic health management in the field of sports medicine.

4. Sue A. Blevins

Institute for Health Freedom

"Americans' Freedom to Choose Their Health Care Provider and Treatments under Various Health Insurance Plans/Systems"

$35,000

With an extensive background in the study of managed care and health insurance at the CATO Institute, Ms. Blevins in her new affiliation will assess both the capabilities for, and barriers to, the American public's access to health care in the current marketplace. It should provide useful information for integrating chiropractic services in the rapidly growing arena of managed care.

5. Clemont Bezold, Ph.D.

Institute for Alternative Futures

"The Future of Alternative Therapies and Chiropractic Health Care"

$280,000

Having received recent major attention in The New England Journal of Medicine, alternative therapies have reached a critical point in their evolution within American health care. At the same time, chiropractic health care as the most popular of these alternative therapies itself faces a great deal of uncertainty. The future of both these classifications of health care comprises a three-part study by the Institute of Alternative Futures.

The first phase of this research is to assemble an advisory committee composed of international leaders in the fields of health care and alternative therapy to direct the project and interact with the NCMIC Board of Directors.

The second phase of the study is to produce a report on the future of alternative therapies in U.S. health care. It will explore two aspects: [i] trends in managed care, health care financing, alternative therapy, the health professions, self care, healthy communities, and systems and technologies; and [ii] the major categories of alternative therapy, including who is using them and who is funding them, concluding with an analysis of the role that alternative remedies are playing and will play in managed care.

The final phase of this research will assess the role that chiropractic health care might play in providing health gains in the context of differing health care scenarios. Several aspects are to be explored, including [i] the role of chiropractic in connection with alternative therapies generally, [ii] the role of chiropractic in managed care, [iii] the evolving nature of licensure and credentialling in relation to outcome measurement, [iv] the preferences and strategies of chiropractors themselves, and [v] the responses of consumers to chiropractic now and in the years ahead. Ten focus groups are to assist in the provision of data for this particular report, half from either the Los Angeles or San Fracisco Bay Area of California and the other from a region [such as Minneapolis, the mid-Atlantic East Coast, or the South] with a different managed care culture.

6. Patricia Brennan, Ph.D.

National College of Chiropractic

"Prostaglandins in Dysmenorrhea: Effect of Manipulation"

$10,000

This stipend represents a supplement to the grant originally awarded by NCMIC to Dr. Brennan for this project in 1993. It will be used to develop at least three manuscripts from the research described above [p. 8]: [i] the results of the primary and secondary outcomes; [ii] the demographics of the patients who chose not to participate; and [iii] the recruitment and accrual of patients to a chirorpactic setting for a study in which the condition under investigation is not musculoskeletal.