John D. Childs, PhD, PT; Julie M. Fritz, PhD, PT; Timothy W. Flynn, PhD, PT; James J. Irrgang, PhD, PT; Kevin K. Johnson; Guy R. Majkowski; Anthony Delitto, PhD, PT
The trial will be registered in Current Controlled Trials (www.controlled-trials.com) in the near future.
Disclaimer: The opinions or assertions contained herein are the private views of the authors and are not to be construed as official or as reflecting the views of the U.S. Air Force or Department of Defense.
Acknowledgments: The authors thank the physical therapy staff at the following sites for their assistance with data collection: Wilford Hall Medical Center, Lackland Air Force Base (AFB); Malcolm Grow Medical Center, Andrews AFB; Wright-Patterson Medical Center, Wright-Patterson AFB; Eglin Hospital, Eglin AFB; Luke Medical Clinic, Luke AFB; Hill Medical Clinic, Hill AFB; F.E. Warren Medical Clinic, F.E. Warren AFB; and University of Pittsburgh Medical Center Health System's Centers for Rehab Services.
Grant Support: By the Foundation for Physical Therapy, Inc., and Wilford Hall Medical Center Commander's Intramural Research Funding Program.
Potential Financial Conflicts of Interest: None disclosed.
Requests for Single Reprints: Maj John D. Childs, PhD, PT, 508 Thurber Drive, Schertz, TX 78154-1146; e-mail, email@example.com.
Current Author Addresses: Dr. Childs: 508 Thurber Drive, Schertz, TX 78154.
Dr. Fritz: Department of Physical Therapy, University of Utah, 520 Wakara Way, Salt Lake City, UT 84108.
Dr. Flynn: Department of Physical Therapy, Regis University, 3333 Regis Boulevard, G-4, Denver, CO 80221-1099.
Drs. Irrgang and Delitto: Department of Physical Therapy, University of Pittsburgh, 6035 Forbes Tower, Pittsburgh, PA 15260.
Mr. Majkowski: Physical Therapy Service, 3851 Roger Brooke Drive, Fort Sam Houston, TX 78234.
Mr. Johnson: 2602 Blue Rock Drive, Beavercreek, OH 45434.
Author Contributions: Conception and design: J.D. Childs, J.M. Fritz, T.W. Flynn, J.J. Irrgang, A. Delitto. Administrative, technical, or logistic support: K.K. Johnson, G.R. Majkowski.
Collection and assembly of data: J.D. Childs, K.K. Johnson, G.R. Majkowski.
Analysis and interpretation of the data: J.D. Childs, J.M. Fritz, T.W. Flynn, J.J. Irrgang.
Drafting of the article: J.D. Childs, J.M. Fritz, A. Delitto.
Critical revision of the article for important intellectual content: J.D. Childs, J.M. Fritz, T.W. Flynn, K.K. Johnson, A. Delitto.
Final approval of the article: J.D. Childs, J.M. Fritz, T.W. Flynn, J.J. Irrgang, K.K. Johnson, G.R. Majkowski, A. Delitto.
Provision of study materials or patients: K.K. Johnson, G.R. Majkowski.
Statistical expertise: J.J. Irrgang.
Obtaining of funding: J.D. Childs, J.M. Fritz.
Conflicting evidence exists about the effectiveness of spinal manipulation.
To validate a manipulation clinical prediction rule.
Multicenter randomized, controlled trial.
Physical therapy clinics.
131 consecutive patients with low back pain, 18 to 60 years of age, who were referred to physical therapy.
Patients were randomly assigned to receive manipulation plus exercise or exercise alone by a physical therapist for 4 weeks.
Patients were examined according to the clinical prediction rule criteria (symptom duration, symptom location, fear–avoidance beliefs, lumbar mobility, and hip rotation range of motion). Disability and pain at 1 and 4 weeks and 6 months were assessed.
Outcome from spinal manipulation depends on a patient's status on the prediction rule. Treatment effects are greatest for the subgroup of patients who were positive on the rule (at least 4 of 5 criteria met); health care utilization among this subgroup was decreased at 6 months. Compared with patients who were negative on the rule and received exercise, the odds of a successful outcome among patients who were positive on the rule and received manipulation were 60.8 (95% CI, 5.2 to 704.7). The odds were 2.4 (CI, 0.83 to 6.9) among patients who were negative on the rule and received manipulation and 1.0 (CI, 0.28 to 3.6) among patients who were positive on the rule and received exercise. A patient who was positive on the rule and received manipulation has a 92% chance of a successful outcome, with an associated number needed to treat for benefit at 4 weeks of 1.9 (CI, 1.4 to 3.5).
The response rate for the 6-month follow-up resulted in inadequate power to detect statistically significant differences for some comparisons.
The spinal manipulation clinical prediction rule can be used to improve decision making for patients with low back pain.
In this randomized, controlled trial, spinal manipulation plus exercise produced outcomes for low back pain similar to those produced by exercise alone. Yet, some patients did respond to spinal manipulation, and it would be helpful for doctors to be able to identify such patients.
Patients were most likely to benefit from spinal manipulation if they met 4 of 5 of the following criteria: symptom duration less than 16 days, no symptoms distal to knee, score less than 19 on a fear-avoidance measure, at least 1 hypomobile lumbar segment, and at least 1 hip with more than 35 degrees of internal rotation.
Clinicians may be able to use these criteria to identify patients with low back pain who are good candidates for spinal manipulation.
Table 1. Five Criteria in the Spinal Manipulation Clinical Prediction Rule
Manipulative intervention used in developing and validating the spinal manipulation clinical prediction rule.
Flow diagram for patient recruitment and randomization.
Table 2. Baseline Demographic and Self-Reported Variables for Both Treatment Groups
Two-dimensional graphical representation of the 3-way clinical prediction rule × treatment group × time interaction for the Oswestry Disability Questionnaire (ODQ) score (P < 0.001).
Table 3. Pairwise Comparisons for the Modified Oswestry Disability Questionnaire Score Change at the 1-Week, 4-Week, and 6-Month Follow-ups
Table 4. Responses to Questions at 6-Month Follow-up
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Myron M. LaBan
William Beaumont Hospital, Royal Oak, MI 48073, Department of PM&R
January 13, 2005
Spinal Pain; A Symptom Not a Diagnosis
Myron M. LaBan, M.D., FACP, FAAPM&R
Department of Physical Medicine & Rehabilitation William Beaumont Hospital 3601 W. Thirteen Mile Road Royal Oak, MI 48073
Phone: 248-898-0162 Fax: 248-642-2483 Email: firstname.lastname@example.org
Key Words: Cervical spine pain, Lumbar spinal pain, Manipulation
The Editor Annals of Internal Medicine 190 N. Independence Mall West Philadelphia, PA 19106-1572, USA
"Spinal Pain"; A Symptom Not a Diagnosis
To the Editor: As a physiatrist honored over 30 years ago by my internist colleague's nomination to the American College of Physicians, I have since looked forward to receiving my monthly issues of the Annals of Internal Medicine. As a past President of the American Academy of Physical Medicine & Rehabilitation and subsequently its liaison to the ACP, I have on a number of occasions privately called attention to the Annal's apparent disturbing editorial policy which continues to treat the issue of spinal pain, i.e., both lumbosacral and cervical, as a generic disease entity rather than more appropriately as a symptomatic complaint. Two articles appearing in the December 2004 issue of the Archives the initial on "neck pain"1 and the later on "low back pain"2 are again but two examples of a continuing cavalier treatment of this complex and challenging entity which in addition to the health issue itself also has significant societal and economic consequences.
The Editors of the Annals would undoubtedly be more discriminating if called upon to publish an article on "stomach pain" and/or "heartburn"! Although the most frequent cause of spinal pain remains that of degenerative disease and its associated osteoarthritic involvement of the zygapophyseal joints, among other significant etiologies are herniated discs, spinal stenosis, occult spinal and paraspinal metastasis3 as well as pathomechanical vascular dysfunction, i.e., aneurysms and cardiomyopathies.4 A failure to discriminate in all treatment series as to the etiology of spinal pain should in this otherwise quality journal preclude publication. To continue to do otherwise, does a disservice to its readers as well as continuing to risk the otherwise well-earned reputation of the Annals. As a caveat after five days of "spinal pain" manipulation has been demonstrated to be no better than conventional physical therapy!5
1.White P, Lewith G, Prescott P, Conway J. Acupuncture versus placebo for the treatment of chronic mechanical neck pain. Ann Intern Med 2004;141:911-919.
2.Childs JD, Fritz JM, Flynn TW, Irrgang JJ, Johnson KK, Majkowski GR, Delitto A. A clinical prediction rule to identify patients with low back pain most likely to benefit from spinal manipulation: a validation study. Ann Intern Med 2004;141:920-28.
3.LaBan MM, Wilkins JCS, Szappanyos B, Shetty AN, Wang A-M. Paravertebral plexus of veins (Batson's) the potential route of paravertebral muscle metastasis as imaged by magnetic venous angiography (MVA). Am J Phys Med Rehabil 1997;76:517-19.
4.LaBan MM, Wilkins JC, Wesolowski DP, Bergeon B, Szappanyos BJ. Paravertebral venous distension (Batson's), an inciting etiological agent in lumbar radiculopathy as observed by venous angiography. Am J Phys Med Rehabil 2001;80:129-33.
5.LaBan MM, Taylor RS. Chiropractic manipulation in low back pain and the recommendations of the Agency for Health Care Policy and Research (HCPR). Letter to the Editor. Ann Internal Med 1999;130:75.
Childs JD, Fritz JM, Flynn TW, Irrgang JJ, Johnson KK, Majkowski GR, et al. A Clinical Prediction Rule To Identify Patients with Low Back Pain Most Likely To Benefit from Spinal Manipulation: A Validation Study. Ann Intern Med. ;141:920–928. doi: 10.7326/0003-4819-141-12-200412210-00008
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Published: Ann Intern Med. 2004;141(12):920-928.
Back Pain, Rheumatology.
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