Full Text PA-97-058
 
RESEARCH ON LOW BACK PAIN AND COMMON SPINAL DISORDERS
 
NIH GUIDE, Volume 26, Number 16, May 16, 1997
 
PA NUMBER:  PA-97-058
 
P.T. 34

Keywords: 
  Musculoskeletal System 
  0715184 
  Communicative Disorders, Hearing 

 
National Institute of Arthritis and Musculoskeletal and Skin Diseases
National Institute of Child Health and Human Development
National Institute of Neurological Disorders and Stroke
National Institute for Occupational Safety and Health, CDC
 
PURPOSE
 
This initiative invites applications directed to the study of the
pathogenesis, epidemiology, prevention, and treatment of three common
causes of low back pain:  (1) herniated nucleus pulposus; (2) spinal
stenosis; and (3) idiopathic low back pain.
 
HEALTHY PEOPLE 2000
 
The Public Health Service (PHS) is committed to achieving the health
promotion and disease prevention objectives of "Healthy People 2000,"
a PHS-led national activity for setting priority areas.  This PA, Low
Back Pain, is related to the priority area of chronic disabling
conditions.  Potential applicants may obtain a copy of "Healthy
People 2000" (Full Report:  Stock No. 017- 001-00474-0 or Summary
Report:  Stock No. 017-001-00473-1) through the Superintendent of
Documents, Government Printing Office, Washington, DC 20402- 9325
(telephone 202-512-1800).
 
ELIGIBILITY REQUIREMENTS
 
Applications may be submitted by foreign and domestic, for-profit and
non-profit organizations, public and private, such as universities,
colleges, hospitals, laboratories, units of State and local
governments, and eligible agencies of the Federal government.
Foreign institutions or organizations in foreign countries are not
eligible for First Independent Research Support and Transition (R29)
awards.  Applications from for minority individuals, women, and
persons with disabilities are encouraged.
 
MECHANISM OF SUPPORT
 
The support mechanisms for grants in this area will be the individual
investigator-initiated research grant (R01) and the First Independent
Research Support and Transition (FIRST) Award (R29).
 
Applicants or collaborators from institutions that have a General
Clinical Research Center (GCRC) funded by the National Center for
Research Resources may wish to identify the GCRC as a resource for
conducting the proposed research.  If so, a letter of agreement from
the GCRC program director should be included with the application.
 
RESEARCH OBJECTIVES
 
Background
 
Low back pain continues to be a significant public health problem.
Seventy to 85% of all people have back pain at some time in life,
with the annual prevalence of back pain ranging from 15-45%. Back
pain is the most frequent cause of activity limitation in people
below 45 years and is a common reason for visiting a health care
provider.  Symptoms are most common in middle-aged adults, with back
pain equally common in men and women; however, back pain secondary to
disc disorders is more common in men.  Reported rates of low back
pain are generally higher for Whites than Blacks or other racial
groups.
 
The recurrence rate of low back pain is very high.  Indeed,
recurrences appear to be part of the natural history.  One year
recurrence rates have been reported ranging from 20-44%.  Lifetime
recurrences of 85% have been reported.  Fortunately, most patients
with back pain recover quickly and without residual functional loss.
Typically, 60-70% recover by 6 weeks and 80-90% by 12 weeks.  After
12 weeks, further recovery is slow.
 
Each year, about 2% of the work force have back injuries covered by
workman's compensation.  The total annual direct cost of treating
this subgroup of low back pain patients rose from $4.6 billion in
1977 to $11.4 billion in 1994.  Typically, 25% or fewer of low back
cases are responsible for 75% or more of the cost.
 
There continues to be great variability in health care service
utilization for low back pain.  From 1979 to 1987, U.S. rates of back
surgery increased 49-55%, while the rate of non-surgical
hospitalization decreased 33%.  Marked geographic variation in the
rate of back surgery (twice as high in the South as compared to the
Northeast) has been reported.  The increase in surgical rates was
especially marked for fusions, which increased 100% from 1979 to
1990.  In addition, there is marked international variation in rates
of back surgery.  A recent study comparing the rates of back surgery
in thirteen countries and provinces revealed that the rate of back
surgery in the U.S. was 40% higher than in any other country or
province.  These differences in surgical rates were not felt to be
due to underlying differences in the prevalence of low back pain.
Complicating this variability in service utilization is the reality
that only a small number of the commonly used non- operative and
operative treatments have been scientifically validated for their
effectiveness/outcomes.
 
This PA is an outgrowth of a workshop sponsored by the NIAMS and the
American Academy of Orthopaedic Surgeons on "New Horizons in Low Back
Pain" in November 1995.  A primary objective of the workshop was to
develop suggestions for future research directions in the
pathogenesis and treatment of common spinal disorders.  A more
detailed description of the proceedings and suggested research topics
is available in Low Back Pain:  A Scientific and Clinical Overview,
edited by J. N. Weinstein and S. L. Gordon, American Academy of
Orthopae dic Surgeons, Chicago, 1996.
 
Scope
 
Through the use of this PA, the NIAMS, the NICHD, the NINDS, and the
NIOSH anticipate the receipt of a broad range of basic science
studies to better understand the pathogenesis, epidemiology, and
prevention of common low back disorders.  In addition, we encourage
the development of patient oriented studies that address:  (1) the
efficacy of current physical examination methods and diagnostic
imaging studies; and (2) the apparent lack of scientific validation
of efficacy/effectiveness/ outcomes of commonly used non-operative
and operative treatments for three of the most common low back
disorders:  herniated nucleus pulposus (ruptured disc), spinal
stenosis, and idiopathic low back pain (low back pain of unknown
etiology).
 
The following are examples of research topics that are appropriate
for this PA; however, they are not to be considered as exclusive or
limiting:
 
o  Studies of the natural history of these common low back
conditions/disorders.
 
o  The roles of cytokines and other inflammatory mediators in the
development and maintenance of acute and chronic pain, and in nerve
root injury.
 
o  A better understanding of the neurophysiology of low back pain in
these disorders.
 
o  Studies to test the hypothesis that clinical spinal instability
relates the spinal derangement or loss of stability to pain.
Identify the important factor(s) associated with clinical instability
in low back pain.
 
o  A better understanding of the contribution of proteoglycans,
and/or their degradation products, as a cause of low back pain.
 
o  A better understanding of the material properties of the annulus
fibrosis, nucleus pulposus, and cartilage end-plate loading modes.
 
o  Develop and/or validate model(s) that mimic the clinical diagnosis
of spinal stenosis.  It is recommended that such models induce
compression by narrowing the spinal canal, rather than by the
introduction of foreign material.
 
o  Study of the pathophysiology of low back pain.  This should
include study of normal physiologic aging of the spine and its
related soft tissues, and how this may relate to the pathophysiology
of low back pain.
 
o  Studies relating deconditioning/loss of muscle strength and/or
coordination to the onset  and/or prolongation of low back pain.
 
o  Studies to further clarify the role of diagnostic testing in
patients with low back pain.  This includes validation of physical
examination techniques, electrodiagnostic techniques (EMG-NCV), and
the timing and effectiveness of commonly used imaging studies (e.g.,
routine xrays, CT scan, MRI).
 
o  Prospective, randomized, controlled, clinical trials of the more
common non-operative and operative treatments currently in use for
these common low back disorders.
 
o  Study of the role of occupational factors in the development,
prognosis, and recovery from low back pain.  Occupational factors
include, but are not limited to, biomechanical stressors, muscle
fatigue, and work organizational factors.
 
o  Studies investigating the incidence, diagnosis, treatment, and
prevention of low back pain  in persons with pre-existing severe
disability (e.g., brain injury, stroke, spinal cord injury,
amputation, cerebral palsy).
 
Applications are encouraged in any scientifically meritorious
research area related to low back pain in these spinal disorders.
Research applications are encouraged from all basic science
disciplines pertinent to this area, as well as the medical
specialties providing health care for these patients, including, but
not limited to:  orthopaedic and neurosurgeons, occupational medicine
physicians, internists and family practitioners, rheumatologists,
physiatrists, chiropractic and osteopathic practitioners, and allied
health providers.
 
INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN
SUBJECTS
 
It is the policy of the NIH that women and members of minority groups
and their subpopulations must be included in all NIH supported
biomedical and behavioral research projects involving human subjects,
unless a clear and compelling rationale and justification is provided
that inclusion is inappropriate with respect to the health of the
subjects or the purpose of the research.  This policy results from
the NIH Revitalization Act of 1993 (Section 492B of Public Law
103-43).
 
All investigators proposing research involving human subjects should
read the "NIH Guidelines for Inclusion of Women and Minorities as
Subjects in Clinical Research," which have been published in the
Federal Register of March 28,1994 (FR 59 14508-14513), and reprinted
in the NIH Guide for Grants and Contract, Volume 23, Number 11, March
18, 1994.
 
APPLICATION PROCEDURES
 
Applications are to be submitted on the grant application form PHS
398 (rev. 5/95) and will be accepted at the standard application
deadlines as indicated in the application kit.  Applications kits are
available at most institutional offices of sponsored research and may
be obtained from the Division of Extramural Outreach and Information
Resources, National Institutes of Health, 6701 Rockledge Drive, MSC
7910, Bethesda, MD 20892-7910, telephone 301/710-0267, email:
[email protected].  The title and number of the program
announcement must be typed in Section 2 on the face page of the
application.
 
Applications for the FIRST Award (R29) must include at least three
sealed letters of reference attached to the face page of the original
application.  FIRST Award (R29) applications submitted without the
required number of reference letters will be considered incomplete
and will be returned without review.
 
The completed original application and five legible copies must be
sent or delivered to:
 
DIVISION OF RESEARCH GRANTS
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710
BETHESDA, MD  20892-7710
BETHESDA, MD  20817 (for express/courier service)
 
REVIEW CONSIDERATIONS
 
Upon receipt, applications will be reviewed for completeness by the
DRG. Incomplete applications will be returned to the applicant
without further consideration.
 
Applications will be assigned on the basis of established Public
Health Service referral guidelines. Applications will be reviewed for
scientific and technical merit by  an appropriate peer review group
convened in accordance with NIH peer review procedures.  As part of
the initial merit review, all applications will receive a written
critique and may undergo a process in which only those applications
deemed to have the highest scientific merit, generally the top half
of all applications under review, will be discussed, assigned a
priority score, and receive a second level review by the appropriate
national advisory council or board.
 
Review Criteria
 
o  Scientific, technical, or medical significance and originality of
proposed research;
 
o  Appropriateness and adequacy of the experimental approach and
methodology proposed to carry out the research;
 
o  Qualifications and research experience of the Principal
Investigator and staff, particularly, but not exclusively, in the
area of the proposed research;
 
o  Availability of the resources necessary to perform the research;
 
o  Appropriateness of the proposed budget and duration in relation to
the proposed research; and
 
o  Adequacy of plans to include both genders and minorities and their
subgroups as appropriate for the scientific goals of the research.
Plans for the recruitment and retention of subjects will also be
evaluated.
 
The Initial Review Group will also examine the provisions for the
protection of human subjects and animal welfare and the safety of the
research environment.
 
AWARD CRITERIA
 
Applications will compete for available funds with all other approved
applications assigned to NIAMS and NINDS.  The following will be
considered in making funding decisions:
 
o  Quality of the proposed project as determined by peer review
o  Availability of funds
o  Program relevance and balance among research areas of the
announcement
 
INQUIRIES
 
Written and telephone inquiries are encouraged.  The opportunity to
clarify any issues or questions from potential applicants is welcome.
 
For scientific programmatic inquiries contact:
 
James S. Panagis, M.D., M.P.H.
Orthopaedics Program
National Institute of Arthritis and Musculoskeletal and Skin Diseases
45 Center Drive, Room 5AS-37K, MSC 4500
Bethesda, MD  20892-6500
Telephone:  (301) 594-5055
FAX:  (301) 480-4543
Email:  [email protected]
 
Stephen M. Tuel, MSE, MD
National Center for Medical and Rehabilitation Research
National Institute of Child Health and Human Development
Building 61E, Room 2A03
Bethesda, MD  20892-7510
Telephone:  (301) 402-2242
FAX:  (301) 402-0832
Email:  [email protected]
 
Mary Ellen Cheung, Ph.D.
Division of Stroke, Trauma, and Neurodegenerative Disorders
National Institute of Neurological Disorders and Stroke
7550 Wisconsin Avenue, Room 8A13
Bethesda, MD  20892-9155
Telephone:  (301) 496-4226
FAX:  (301) 480-1080
Email:  [email protected]
 
Larry Fine, MD, DrP.H.
Division of Surveillance, Hazard Evaluations and Field Studies
National Institute for Occupational Safety and Health, CDC
4676 Columbia Parkway, Mail Stop R-12
Cincinnati, OH  45226-1998
Telephone:  (513) 841-4428
FAX: (513) 841-4483
Email:  [email protected]
 
Direct inquiries regarding fiscal matters to:
 
Vicki Maurer
Grants Management Branch
National Institute of Arthritis and Musculoskeletal and Skin Diseases
45 Center Drive, Room 5AS-49A, MSC 4500
Bethesda, MD  20892-6500
Telephone:  (301) 594-3504
FAX:  (301) 480-5450
Email:  [email protected]
 
Mary Ellen Colvin
Grants Management Branch
National Institute of Child Health and Human Development
Building 61E, Room 8A017
Bethesda, MD  20892-7510
Telephone:  (301) 496-1303
FAX:  (301) 402-0915
Email:  [email protected]
 
Gladys Melendez-Bohler
Grants Management Branch
National Institute of Neurological Disorders and Stroke
7550 Wisconsin Avenue, Room 1004
Bethesda, MD  20892-9190
Telephone:  (301) 496-9231
FAX:  (301) 402-0219
Email:  [email protected]
 
Roy Fleming
Grants Management Branch
National Institute for Occupational Safety and Health
1600 Cliffton Road, N.E., Building 1
Mail Stop D30
Atlanta, GA  30333
Telephone:  (404) 639-2810
FAX:  (404) 639-2196
Email:  [email protected]
 
AUTHORITY AND REGULATIONS
 
Awards made in this program are described in the Catalog of Federal
Domestic Assistance No. 93.846, Arthritis, Musculoskeletal and Skin
Diseases Research, the National Institute of Arthritis and
Musculoskeletal and Skin Diseases,  No. 98.853, Clinical Research
Related to Neurological Disorders, and No. 93.854, Biological Basis
Research in the Neurosciences, the National Institute of Neurological
Disorders and Stroke.  Awards will be made under the authority of the
Public Health Service Act, Title III, Section 301 (Public Law 410,
78th Congress, as amended, 42 USC 241) and administered under PHS
grant policies and Federal regulations 42 CFR Part 52 and 45 CFR Part
74. This program is not subject to intergovernmental review
requirements of Executive Order 12372 or Health Systems Agency
review.
 
The PHS strongly encourages all grant and contract recipients to
provide a smoke-free workplace and promote the non-use of all tobacco
products.  In addition, Public Law 103-227, the Pro-Children Act of
1994, prohibits smoking in certain facilities (or in some cases, any
portion of a facility) in which regular or routine education,
library, day care, health care or early childhood development
services are provided to children.  This is consistent with the PHS
mission to protect and advance the physical and mental health of the
American people.
 
.

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