J Manipulative Physiol Ther. 2002 (Jan); 25 (1): 1020 ~ FULL TEXT
Ruth P. Hertzman-Miller, MD, MPH, Hal Morgenstern, PhD, Eric L. Hurwitz, DC, PhD,
Fei Yu, PhD, Alan H. Adams, DC, MS, Philip Harber, MD, MPH, and Gerald F. Kominski, PhD
UCLA School of Public Health,
Department of Epidemiology,
Los Angeles, Calif. 90095-1772, USA.
BACKGROUND: Although chiropractors often use physical modalities with spinal manipulation, evidence that modalities yield additional benefits over spinal manipulation alone is lacking.
OBJECTIVE: The purpose of the study was to estimate the net effect of physical modalities on low back pain (LBP) outcomes among chiropractic patients in a managed-care setting.
METHODS: Fifty percent of the 681 patients participating in a clinical trial of LBP treatment strategies were randomized to chiropractic care with physical modalities (n = 172) or without physical modalities (n = 169). Subjects were followed for 6 months with assessments at 2, 4, and 6 weeks and at 6 months. The primary outcome variables were average and most severe LBP intensity in the past week, assessed with numerical rating scales (0-10), and low back-related disability, assessed with the 24-item Roland-Morris Disability Questionnaire.
RESULTS: Almost 60% of the subjects had baseline LBP episodes of more than 3 months' duration. The 6-month follow-up was 96%. The adjusted mean differences between groups in improvements in average and most severe pain and disability were clinically insignificant at all follow-up assessments. Clinically relevant improvements in average pain and disability were more likely in the modalities group at 2 and 6 weeks, but this apparent advantage disappeared at 6 months. Perceived treatment effectiveness was greater in the modalities group.
CONCLUSIONS: Physical modalities used by chiropractors in this managed-care organization did not appear to be effective in the treatment of patients with LBP, although a small short-term benefit for some patients cannot be ruled out.
Keywords: Low Back Pain, Chiropractic, Physical Therapy, Randomized Controlled Trial, Managed Care
From the Full-Text Article:
Low back pain (LBP) is the most common reason for initiating chiropractic care,  and chiropractic is the unconventional or alternative therapy used most often for back pain in the United States. [2, 3] In fact, most visits for LBP are to chiropractors,  and because managed care predominates in many parts of the United States,  these visits are increasingly in managed-care settings. Back-related health care expenditures have been rising dramatically, primarily the result of escalating costs associated with disabling LBP.  Back pain is also a leading cause of lost work days, resulting in almost $9 billion in work-related low-back claims and billions of dollars in additional indirect costs. [7, 8]
Low back pain is treated with a variety of therapies by a number of different health care providers. [9, 10] Physical modalities, such as heat therapy, ultrasound, and electrical muscle stimulation (EMS) are specific treatments that many chiropractors commonly use in conjunction with spinal manipulation. [11, 12] Although there is little evidence that physical modalities alone are effective therapies for LBP, [13, 14] there have been no published studies, to our knowledge, that address the relative benefit of modalities applied to patients with LBP who are receiving chiropractic care.
The purpose of the study was to estimate the net effect of physical modalities used at the discretion of chiropractors in managed care.
The effectiveness of physical modalities among patients with LBP randomized to chiropractic care was assessed in a managed-care practice setting. During 6 months of follow-up in this population of patients with primarily subacute and chronic pain, chiropractic care with or without physical modalities yielded mostly similar pain and disability outcomes. Most patients in both treatment groups had clinically meaningful reductions in pain severity and disability, although the majority of subjects reported at least some pain and impaired function from back pain at 6 months. These findings add to the evidence showing that physical modalities provide, at best, minimal short-term benefit for patients with LBP who are receiving chiropractic care. Specific agents or modalities might, however, be effective in certain patients or in other settings.
Satisfaction with chiropractic care was equally high in both treatment groups, yet patients assigned to receive modalities were more likely to strongly agree that the treatment they received was effective and more likely to seek similar care for future back pain episodes. Because patients were not blinded, these findings illustrating greater perceived benefit do not necessarily reflect greater clinical benefit. For example, patients may simply equate the applications of additional treatments (eg, ultrasound, EMS) as better care regardless of their therapeutic value. Alternatively, modalities may offer patients transient symptomatic relief or improvements in other unmeasured health outcomes that we failed to consider. As a discrete therapy, spinal manipulation as routinely used by chiropractors in the United States and elsewhere has been shown to be beneficial for patients with acute LBP, at least in the short term, [9, 31] and may be an effective treatment for chronic pain.  Current evidence does not support the use of EMS, ultrasound, and other passive modalities for acute or chronic LBP. [9, 31, 32] Exercise and other active physical therapeutic interventions may be of some benefit. [9, 10, 14] Harm resulting from spinal manipulation or physical modalities for LBP is remote. [9, 31, 32]
We are unaware of other randomized clinical trials (RCTs) that have compared chiropractic with and without physical modalities, although 4 RCTs comparing chiropractic care with physical therapy for LBP have been published. Outcomes from chiropractic and hospital outpatient (physiotherapy) care were clinically similar in the Meade et al trial, [33, 34] yet chiropractic patients reported greater satisfaction. Postacchini et al35 and Skargren et al [36, 37] also found little difference between outcomes from chiropractic and physical therapy at 6 or 12 months, although chiropractic patients expectations were more likely to have been fulfilled in the latter trial. During 2 years follow-up of patients randomized to chiropractic or McKenzie physical therapy,  satisfaction and pain and disability outcomes were similar.
The findings from prior studies are consistent with our results showing the ineffectiveness of physical modalities. [9, 10, 14] Active rather than passive interventions, however, may be of benefit for some patients with subacute and chronic LBP. Supervised exercise classes were found to be more effective than primary medical care for patients with subacute LBP after 6 and 12 months,  and supervised exercise interventions led to greater reductions in pain, disability, and costs than self exercise among patients with chronic pain after 12 months.  The value of supervised exercise (vs self exercise) for patients with chronic LBP is also supported by another recent trial that followed patients for 2 years.  However, the authors of an RCT that compared low-impact aerobics with active physical therapy and muscle reconditioning among patients with chronic LBP found equivalent pain and disability outcomes with much less cost in the aerobics group after 6 months. 
The major limitation of our study is its potential lack of generalizability to other practice settings and patient populations. Given that the trial was conducted within 1 managed-care organization, extrapolating our findings to patients with LBP in other settings may be inappropriate. Patients under other reimbursement models, such as fee-for-service, workers compensation, and third party liability, may differ in ways that affect treatment outcomes. In addition, chiropractors practicing in other environments may differ in their relations with patients, manipulative techniques, the frequency and duration of visits, the length and intensity of LBP care, and in their overall approach to patients. Findings from a recent study of chiropractic utilization in North America, for example, documented wide geographic variation in the frequency of visits during episodes of back-pain care.1 Despite possible differences, other ambulatory LBP patient populations are similar to ours in terms of back-pain severity [38, 43, 44] and disability, [15, 43, 4547] and most chiropractors in the United States are taught and use the same general types of spinal manipulation used by the chiropractors at our study site. [11, 12]
Physical modalities used at the discretion of chiropractors in this managed-care setting do not appear to be more effective than chiropractic care without modalities in the treatment of patients with LBP, although a small short-term benefit for some patients cannot be ruled out. Given the added expense of office-based modalities, chiropractors may deliver equally effective and more cost-effective care by withholding modalities, educating patients, and perhaps recommending at-home applications of agents for the temporary relief of symptoms. However, the discrepancy between effects on pain and disability outcomes and perceptions of treatment effectiveness suggests that modalities may enhance the real or perceived effectiveness of chiropractic care among some patients. The perceptions of patients with LBP regarding treatment effectiveness and how these perceptions relate to clinical outcomes and costs and to preferences for subsequent care should be investigated in future studies.
Hurwitz, EL, Coulter, ID, Adams, AH, Genovese, BJ, and Shekelle, PG.
Use of chiropractic services from 1985 through 1991 in the United States and Canada.
Am J Public Health. 1998; 88: 771776
Druss, BG and Rosenheck, RA.
Association between use of unconventional therapies and conventional medical services.
JAMA. 1999; 282: 651656
Eisenberg DM, Davis RB, Ettner SL, et al.
Trends in Alternative Medicine Use in the United States, 1990-1997
Results of a Follow-up National Survey
JAMA 1998 (Nov 11); 280: 156975
Shekelle, PG and Brook, RH.
A community-based study of the use of chiropractic services.
Am J Public Health. 1991; 81: 439442
National ambulatory medical care survey: 1997 summary.
Advance data from vital and health statistics, No. 305.
National Center for Health Statistics, Hyattsville (MD); 1999
Low back pain: a twentieth century health care enigma.
Spine. 1996; 21: 28202825
Guo, H-R, Tanaka, S, Halperin, WE, and Cameron, LL.
Back pain prevalence in US industry and estimates of lost workdays.
Am J Public Health. 1999; 89: 10291035
Murphy, PL and Volinn, E.
Is occupational low back pain on the rise?.
Spine. 1999; 247: 691697
Stanley J. Bigos, MD, Rev. O. Richard Bowyer, G. Richard Braen, MD, et al.
Acute Lower Back Problems in Adults. Clinical Practice Guideline No. 14.
Rockville, MD: Agency for Health Care Policy and Research, [AHCPR Publication No. 95-0642].
Public Health Service, U.S. Department of Health and Human Services; 1994
van Tulder, MW, Koes, BW, and Bouter, LM.
Conservative treatment of acute and chronic nonspecific low back pain: a systematic review of randomized controlled trials of the most common interventions.
Spine. 1997; 22: 21282156
Cherkin DC, Mootz RD, eds.
Chiropractic in the United States: Training, Practice, and Research
Rockville, Md: Agency for Health Care Policy and Research,
Public Health Service, US Dept of Health and Human Services; 1997.
AHCPR publication 98-N002.
Christensen MG, Kerkhoff D, Kollasch MW.
Job Analysis of Chiropractic 2000
Greeley (CO): National Board of Chiropractic Examiners, 2000.
Feine, JS and Lund, JP.
An assessment of the efficacy of physical therapy and physical modalities for the control of chronic musculoskeletal pain.
Pain. 1997; 71: 523
Nordin, M and Campello, M.
Physical therapy. Exercises and the modalities: when, what and why?.
Neurol Clin North Am. 1999; 17: 7589
Roland, M and Morris, R.
A study of the natural history of back painpart I: development of a reliable and sensitive measure of disability in low-back pain.
Spine. 1983; 8: 141150
Comparative validity of sickness impact profile and shorter scales for functional assessment in low-back pain.
Spine. 1986; 11: 951954
Jensen, MP, Strom, SE, Turner, JA, and Romano, JM.
Validity of the sickness impact profile Roland scale as a measure of dysfunction in chronic pain patients.
Pain. 1992; 50: 157162
Deyo, RA and Centor, RM.
Assessing responsiveness of functional scales to clinical change: analogy to diagnostic test performance.
J Chronic Dis. 1986; 39: 897906
Hsieh, CJ, Phillips, RB, Adams, AH, and Pope, MH.
Functional outcomes of low back pain: comparison of four treatment groups in a randomized controlled trial.
J Manipulative Physiol Ther. 1992; 15: 49
Stratford, PW, Binkley, J, Solomon, P, Gill, C, and Finch, E.
Assessing change over time in patients with low back pain.
Phys Ther. 1994; 74: 528533
Bouter, LM, van Tulder, MW, and Koes, BW.
Methodologic issues in low back pain research in primary care.
Spine. 1998; 23: 20142020
Roland, M and Fairbank, J.
The Roland-Morris Disability Questionnaire and the Oswestry Disability Questionnaire.
Spine. 2000; 25: 31153124
Strong, J, Ashton, R, and Chant, D.
Pain intensity measurement in chronic low back pain.
Clin J Pain. 1991; 7: 209218
Von Korff, M, Jensen, MP, and Karoly, P.
Assessing global pain severity by self-report in clinical and health services research.
Spine. 2000; 25: 31403151
Ware, JE and Sherbourne, CD.
The MOS 36-Item Short-Form Health Survey (SF-36): I. Conceptual framework and item selection.
Med Care. 1992; 30: 473483
McHorney, CA and Ware, JE.
Construction and validation of an alternate form general mental health scale for the Medical Outcomes Study Short-Form Health Survey.
Med Care. 1995; 33: 1528
SF-36 Health survey update.
Spine. 2000; 25: 31303139
Patrick, DL, Deyo, RA, Atlas, SJ, Singer, DE, Chapin, A, and Keller, RB.
Assessing health-related quality of life in patients with sciatica.
Spine. 1995; 20: 18991909
Deyo, RA, Battie, M, Beurskens, AJHM, Bombardier, C, Croft, P, Koes, B et al.
Outcome measures for low back pain research: a proposal for standardized use.
Spine. 1998; 23: 20032013
SAS, Institute Inc.
The SAS System for Windows 8.1.
SAS Institute Inc, Cary, North Carolina; 2000
Shekelle, PG, Adams, AH, Chassin, MR, Hurwitz, EL, and Brook, RH.
Spinal manipulation for low-back pain.
Ann Intern Med. 1992; 117: 590598
Assendelft, WJJ, Bouter, LM, and Knipschild, PG.
Complications of spinal manipulation: a comprehensive review of the literature.
J Fam Pract. 1996; 42: 475480
Meade TW, Dyer S, Browne W, et al.
Low Back Pain of Mechanical Origin: Randomised Comparison of Chiropractic and Hospital Outpatient Treatment
British Medical Journal 1990 (Jun 2); 300 (6737): 14311437
Meade TW, Dyer S, Browne W, et al:
Randomised Comparison of Chiropractic and Hospital Outpatient Management for Low Back Pain:
Results from Extended Follow up
British Medical Journal 1995 (Aug 5); 311 (7001): 349351
Postacchini, F, Facchini, M, and Palieri, P.
Efficacy of various forms of conservative treatment in low back pain: a comparative study.
Neuroorthop. 1988; 6: 2835
Skargren, EI, Oberg, BE, Carlsson, PG, and Gade, M.
Cost and effectiveness analysis of chiropractic and physiotherapy treatment for low back and neck pain: six-month follow-up.
Spine. 1997; 22: 21672177
Skargren, EI, Carlsson, PG, and Oberg, BE.
One-year follow-up comparison of the cost and effectiveness of chiropractic and physiotherapy as primary management for back pain: subgroup analysis, recurrence, and additional health care utilization.
Spine. 1998; 23: 18751884
Cherkin DC, Deyo RA, Battie M, et al.
A Comparison of Physical Therapy, Chiropractic Manipulation, and Provision
of an Educational Booklet for the Treatment of Patients with Low Back Pain
New England Journal of Medicine 1998 (Oct 8); 339 (15): 1021-1029
Moffett, JK, Torgerson, D, Bell-Syer, S, Jackson, D, Llewlyn-Phillips, H, Farrin, A et al.
Randomised controlled trial of exercise for low back pain: clinical outcomes, costs, and preferences.
BMJ. 1999; 319: 279283
Torstensen, TA, Ljunggren, AE, Meen, HD, Odland, E, Mowinckel, P, and Geijerstam, S.
Efficiency and costs of medical exercise therapy, conventional physiotherapy, and self-exercise in patients with chronic low back pain. A pragmatic, randomized, single-blinded, controlled trial with 1-year follow-up.
Spine. 1998; 23: 26162624
Frost, H, Lamb, SE, Klaber Moffett, JA, Fairbank, JCT, and Moser, JS.
A fitness programme for patients with chronic low back pain: 2-year follow-up of a randomised controlled trial.
Pain. 1998; 75: 273279
Mannion, AF, Muntener, M, Taimela, S, and Dvorak, J.
A randomized clinical trial of three active therapies for chronic low back pain.
Spine. 1999; 24: 24352448
Leclaire, R, Esdaile, JM, Suissa, S, Rossignol, M, Prouix, R, and Dupuis, M.
Back school in a first episode of compensated acute low back pain: a clinical trial to assess efficacy and prevent relapse.
Arch Phys Med Rehabil. 1996; 77: 673679
Malmivaara, A, Hakkinen, U, Aro, T, Heinrichs, CL, Koskenniemi, L, and Kuosma, E.
The treatment of acute low back painbed rest, exercises, or ordinary activity?.
N Engl J Med. 1995; 332: 351355
Stucki, G, Liang, MH, Fossel, AH, and Katz, JN.
Relative responsiveness of condition-specific and general health status measures in degenerative lumbar spinal stenosis.
J Clin Epidemiol. 1995; 48: 13691378
Stratford, PW, Binkley, J, Solomon, P, Finch, E, Gill, C, and Moreland, J.
Defining the minimum level of detectable change for the Roland-Morris questionnaire.
Phys Ther. 1996; 76: 359365
Burton, AK, Tillotson, KM, Main, CJ, and Hollis, S.
Psychosocial predictors of outcome in acute and subchronic low back trouble.
Spine. 1995; 20: 722728
Return to LOW BACK PAIN