Efficacy of Osteopathic Manipulative Medicine (OMM) and Phototherapy for Patients With Chronic Lower Back Pain

Efficacy of Osteopathic Manipulative Medicine (OMM) and Phototherapy for Patients With Chronic Lower Back Pain

Efficacy of Osteopathic Manipulative Medicine (OMM) and Phototherapy for Patients With Chronic Lower Back Pain

The purpose of the research study entitled "Efficacy of Osteopathic Manipulative Medicine (OMM) and Phototherapy for Patients with Chronic Lower Back Pain" is to investigate the hypothesis that combined treatment with both osteopathic manipulative medicine (OMM) and phototherapy will provide greater pain relief for patients with chronic lower back pain, as compared with standard medical management or either treatment alone.

The research has demonstrated separately that phototherapy and osteopathic manipulative medicine (OMM) are effective in reducing chronic low back pain, However there has not been any research to evaluate whether the interaction of the two treatment approaches together can provide enhanced pain relief. In A Meta-analysis of the Efficacy of Phototherapy in Tissue Repair, Fulop et.al.(1) from the Department of Physical Therapy, School of Health Professions, New York Institute of Technology (NYIT) concluded that "phototherapy is a highly effective form of treatment for tissue repair, with stronger supporting evidence resulting from experimental animal studies than human studies" (Fulop, p. 695, 699). Further review of the literature by Fulop et. al. (2) focused on the question of pain relief in relation to phototherapy, and the conclusion was that pain from various etiologies can be effectively relieved by phototherapy. The U.S. Food and Drug Administration has cleared biostimulation lasers (a.k.a. low level laser therapy [LLLT], cold lasers, soft lasers, or laser acupuncture devices) for marketing as "adjunctive devices for the temporary relief of pain" (3). Thus, both health practitioners and the lay public have access to and may potentially obtain and use phototherapy devices manufactured by various companies. Other research protocols by Gur, A et. al. (4) and Djavid, GE et. al. (5) evaluated patients with chronic low back pain in relation to the combined effectiveness of low level laser therapy and exercise. These studies showed positive results with the combined approaches. Osteopathic physicians utilize an approach to the treatment of patients called osteopathic manipulative medicine (OMM). The osteopathic physician will diagnose somatic dysfunction, and then treat the dysfunctions found with one or more of several OMM treatment approaches. The American Osteopathic Association (AOA) published in 2009 the "Guidelines for Osteopathic Manipulative Treatment (OMT) for Patients with Low Back Pain." These guidelines are available both through the AOA and the Agency for Healthcare Research and Quality (AHRQ), National Guideline Clearinghouse (6). This guideline (6) specifically addresses the "efficacy of osteopathic manipulation treatment in reducing low back pain" (p. 2). A review of the literature was performed, and after selection a total of "six trials, involving eight osteopathic manipulative treatment (OMT) vs control treatment comparisons, were included" in the meta-analysis (p. 2-3). The major recommendation stated in the guideline is that "osteopathic manipulative treatment (OMT) be utilized by osteopathic physicians for musculoskeletal causes of back pain, i.e., to treat the diagnoses of somatic dysfunctions related to the low back pain" (p.4). In addition, the meta-analysis performed did show that OMT for patients with low back pain led to statistically significant reduction in pain (p. 5). Thus, the potential for a complementary approach to patient care in cases of chronic low back pain exists. Yet, no studies to date have specifically evaluated this particular hypothesis regarding OMT and phototherapy for patients with chronic low back pain. The purpose of this research is to evaluate this question of enhanced combined efficacy for the overall benefit of patients.

Inclusion Criteria: Age range: 18 - 65 years old Subjects with constant or intermittent nonspecific lower back pain for a minimum of three (3) months duration. Exclusion Criteria: Prospective subjects with a diagnosis of the following potential underlying causes of lower back pain: ankylosing spondylitis, cancer or a history of a histologically demonstrated malignant carcinoma, cauda equine syndrome, herniated disc, spinal fracture, or spinal osteomyelitis. Prospective subjects who have undergone surgery of the lower back in the preceding three (3) months. Prospective subjects who have received worker's compensation in the preceding three (3) months, or are involved in litigation involving concerns of lower back. Prospective subjects who are pregnant. Prospective subjects who have been a patient receiving any osteopathic manipulative medicine (OMM) treatment at the clinical trial site in the previous three (3) months, or on greater than three (3) occasions in the preceding year. Prospective subjects who have ever been an employee at the clinical trial site. Prospective subjects who have received spinal manipulation in the previous three (3) months, or on greater than three (3) occasions in the preceding year. Prospective subjects who are currently involved in a physical therapy rehabilitation program. Prospective subjects who have photosensitivity.

Fulop AM, Dhimmer S, Deluca JR, Johanson DD, Lenz RV, Patel KB, Douris PC, Enwemeka CS. A meta-analysis of the efficacy of phototherapy in tissue repair. Photomed Laser Surg. 2009 Oct;27(5):695-702. doi: 10.1089/pho.2009.2550.

Gur A, Karakoc M, Cevik R, Nas K, Sarac AJ, Karakoc M. Efficacy of low power laser therapy and exercise on pain and functions in chronic low back pain. Lasers Surg Med. 2003;32(3):233-8. doi: 10.1002/lsm.10134.

Djavid GE, Mehrdad R, Ghasemi M, Hasan-Zadeh H, Sotoodeh-Manesh A, Pouryaghoub G. In chronic low back pain, low level laser therapy combined with exercise is more beneficial than exercise alone in the long term: a randomised trial. Aust J Physiother. 2007;53(3):155-60. doi: 10.1016/s0004-9514(07)70022-3. Erratum In: Aust J Physiother. 2007;53(4):216.

Licciardone JC, Stoll ST, Fulda KG, Russo DP, Siu J, Winn W, Swift J Jr. Osteopathic manipulative treatment for chronic low back pain: a randomized controlled trial. Spine (Phila Pa 1976). 2003 Jul 1;28(13):1355-62. doi: 10.1097/01.BRS.0000067110.61471.7D.

Williams NH, Wilkinson C, Russell I, Edwards RT, Hibbs R, Linck P, Muntz R. Randomized osteopathic manipulation study (ROMANS): pragmatic trial for spinal pain in primary care. Fam Pract. 2003 Dec;20(6):662-9. doi: 10.1093/fampra/cmg607.

Williams N. Managing back pain in general practice--is osteopathy the new paradigm? Br J Gen Pract. 1997 Oct;47(423):653-5.

Ferreira ML, Ferreira PH, Latimer J, Herbert RD, Hodges PW, Jennings MD, Maher CG, Refshauge KM. Comparison of general exercise, motor control exercise and spinal manipulative therapy for chronic low back pain: A randomized trial. Pain. 2007 Sep;131(1-2):31-7. doi: 10.1016/j.pain.2006.12.008. Epub 2007 Jan 23.

Burton AK, McClune TD, Clarke RD, Main CJ. Long-term follow-up of patients with low back pain attending for manipulative care: outcomes and predictors. Man Ther. 2004 Feb;9(1):30-5. doi: 10.1016/s1356-689x(03)00052-3.

Harvey E, Burton AK, Moffett JK, Breen A; UK BEAM trial team. Spinal manipulation for low-back pain: a treatment package agreed to by the UK chiropractic, osteopathy and physiotherapy professional associations. Man Ther. 2003 Feb;8(1):46-51. doi: 10.1054/math.2002.0472.

Kimberly PE. Formulating a prescription for osteopathic manipulative treatment. J Am Osteopath Assoc. 1980 Apr;79(8):506-13. No abstract available.

Ramirez MA, Haman J, Worth L. Low back pain: diagnosis by six newly discovered sacral tender points and treatment with counterstrain. J Am Osteopath Assoc. 1989 Jul;89(7):905-6, 911-3.

Hoffman KS, Hoffman LL. Effects of adding sacral base leveling to osteopathic manipulative treatment of back pain: a pilot study. J Am Osteopath Assoc. 1994 Mar;94(3):217-20, 223-6.

Jokl P. Twenty-eighth annual AOA/NOF Research Conference, 1984: part I. Keynote address: Muscle and low-back pain. J Am Osteopath Assoc. 1984 Sep;84(1):64-6. No abstract available.

Hoyt WH, Bard DA, Shaffer F. Experience with an antigravity leverage device for chronic low back pain: a clinical study. J Am Osteopath Assoc. 1981 Mar;80(7):474-9. No abstract available.

Korr IM. The spinal cord as organizer of disease processes: IV. Axonal transport and neurotrophic function in relation to somatic dysfunction. J Am Osteopath Assoc. 1981 Mar;80(7):451-9. No abstract available.

Licciardone JC. The unique role of osteopathic physicians in treating patients with low back pain. J Am Osteopath Assoc. 2004 Nov;104(11 Suppl 8):S13-8.

Nadler SF. Nonpharmacologic management of pain. J Am Osteopath Assoc. 2004 Nov;104(11 Suppl 8):S6-12.

Hoehler FK, Tobis JS, Buerger AA. Spinal manipulation for low back pain. JAMA. 1981 May 8;245(18):1835-8.

Niemisto L, Sarna S, Lahtinen-Suopanki T, Lindgren KA, Hurri H. Predictive factors for 1-year outcome of chronic low back pain following manipulation, stabilizing exercises, and physician consultation or physician consultation alone. J Rehabil Med. 2004 May;36(3):104-9. doi: 10.1080/16501970310019151.

Tong HC, Heyman OG, Lado DA, Isser MM. Interexaminer reliability of three methods of combining test results to determine side of sacral restriction, sacral base position, and innominate bone position. J Am Osteopath Assoc. 2006 Aug;106(8):464-8.

Snider KT, Johnson JC, Snider EJ, Degenhardt BF. Increased incidence and severity of somatic dysfunction in subjects with chronic low back pain. J Am Osteopath Assoc. 2008 Aug;108(8):372-8.

Andersson GB, Lucente T, Davis AM, Kappler RE, Lipton JA, Leurgans S. A comparison of osteopathic spinal manipulation with standard care for patients with low back pain. N Engl J Med. 1999 Nov 4;341(19):1426-31. doi: 10.1056/NEJM199911043411903.

Gamber R, Holland S, Russo DP, Cruser dA, Hilsenrath PE. Cost-effective osteopathic manipulative medicine: a literature review of cost-effectiveness analyses for osteopathic manipulative treatment. J Am Osteopath Assoc. 2005 Aug;105(8):357-67.

McPartland JM, Giuffrida A, King J, Skinner E, Scotter J, Musty RE. Cannabimimetic effects of osteopathic manipulative treatment. J Am Osteopath Assoc. 2005 Jun;105(6):283-91.

Licciardone JC, Russo DP. Blinding protocols, treatment credibility, and expectancy: methodologic issues in clinical trials of osteopathic manipulative treatment. J Am Osteopath Assoc. 2006 Aug;106(8):457-63.

Wearn AM, Greenfield SM. Access to complementary medicine in general practice: survey in one UK health authority. J R Soc Med. 1998 Sep;91(9):465-70. doi: 10.1177/014107689809100904.

Mein EA, Greenman PE, McMillin DL, Richards DG, Nelson CD. Manual medicine diversity: research pitfalls and the emerging medical paradigm. J Am Osteopath Assoc. 2001 Aug;101(8):441-4.

Navratil L, Kymplova J. Contraindications in noninvasive laser therapy: truth and fiction. J Clin Laser Med Surg. 2002 Dec;20(6):341-3. doi: 10.1089/104454702320901134.

Fulop AM, Dhimmer S, Deluca JR, Johanson DD, Lenz RV, Patel KB, Douris PC, Enwemeka CS. A meta-analysis of the efficacy of laser phototherapy on pain relief. Clin J Pain. 2010 Oct;26(8):729-36. doi: 10.1097/AJP.0b013e3181f09713.

Patterson, MM, PhD, Editorial - Research in OMT: What is the question and do we understand it?, JAOA, January 2007, Vol. 107, No. 1, pp. 8-11.

Cameron, Michelle H., Physical Agents in Rehabilitation: From Research to Practice, Third Edition, Chapter 12, Electromagnetic Radiation: Lasers and Light, Saunders Elsevier, 2009.

Task Force on the Low Back Pain Clinical Practice Guidelines. American Osteopathic Association Guidelines for Osteopathic Manipulative Treatment (OMT) for Patients With Low Back Pain. J Am Osteopath Assoc. 2016 Aug 1;116(8):536-49. doi: 10.7556/jaoa.2016.107.

AHRQ - American Osteopathic Association guidelines for osteopathic manipulative treatment (OMT) for patients with low back pain