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Osteopathic Medicine and Primary Care

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Open Access 01-12-2008 | Study protocol

OSTEOPAThic Health outcomes In Chronic low back pain: The OSTEOPATHIC Trial

Authors: John C Licciardone, Hollis H King, Kendi L Hensel, Daniel G Williams

Published in: Osteopathic Medicine and Primary Care | Issue 1/2008

Abstract

Background

Osteopathic manipulative treatment (OMT) and ultrasound physical therapy (UPT) are commonly used for chronic low back pain. Although there is evidence from a systematic review and meta-analysis that OMT generally reduces low back pain, there are no large clinical trials that specifically assess OMT efficacy in chronic low back pain. Similarly, there is a lack of evidence involving UPT for chronic low back pain.

Methods

The OSTEOPAThic Health outcomes In Chronic low back pain (OSTEOPATHIC) Trial is a Phase III randomized controlled trial that seeks to study 488 subjects between August 2006 and June 2010. It uses a 2 × 2 factorial design to independently assess the efficacy of OMT and UPT for chronic low back pain. The primary outcome is a visual analogue scale score for pain. Secondary outcomes include back-specific functioning, generic health, work disability, and satisfaction with back care.

Conclusion

This randomized controlled trial will potentially be the largest involving OMT. It will provide long awaited data on the efficacy of OMT and UPT for chronic low back pain.

Trial registration

http://www.clinicaltrials.gov, NCT00315120

Available only for authorised users

Cypress BK: Characteristics of physician visits for back symptoms: a national perspective. Am J Public Health. 1983, 73: 389-395. 10.2105/AJPH.73.4.389.PubMedCentralCrossRefPubMed

Licciardone JC, Herron KM: Characteristics, satisfaction, and perceptions of patients receiving ambulatory healthcare from osteopathic physicians: a comparative national survey. J Am Osteopath Assoc. 2001, 101: 374-385.PubMed

Licciardone JC: Awareness and use of osteopathic physicians in the United States: results of the Second Osteopathic Survey of Health Care in America (OSTEOSURV-II). J Am Osteopath Assoc. 2003, 103: 281-289.PubMed

Licciardone JC: The unique role of osteopathic physicians in treating patients with low back pain. J Am Osteopath Assoc. 2004, 104 (11 Suppl 8): S13-18.PubMed

Seffinger MA, King HH, Ward RC, Jones JM, Rogers FJ, Patterson MM: Osteopathic philosophy. Foundations for Osteopathic Medicine. Edited by: Ward RC. 2003, Philadelphia, PA: Lippincott Williams & Wilkins, 3-18. 2

Hoehler FK, Tobis JS, Buerger AA: Spinal manipulation for low back pain. JAMA. 1981, 245: 1835-1838. 10.1001/jama.245.18.1835.CrossRefPubMed

Gibson T, Grahame R, Harkness J, Woo P, Blagrave P, Hills R: Controlled comparison of short-wave diathermy treatment with osteopathic treatment in non-specific low back pain. Lancet. 1985, 1: 1258-1261. 10.1016/S0140-6736(85)92323-2.CrossRefPubMed

MacDonald RS, Bell CM: An open controlled assessment of osteopathic manipulation in nonspecific low-back pain. Spine. 1990, 15: 364-370. 10.1097/00007632-199005000-00005.CrossRefPubMed

Cleary C, Fox JP: Menopausal symptoms: an osteopathic investigation. Complementary Therapies in Medicine. 1994, 2: 181-186. 10.1016/0965-2299(94)90017-5.CrossRef

10.

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. New Engl J Med. 1999, 341: 1426-1431. 10.1056/NEJM199911043411903.CrossRefPubMed

11.

Burton AK, Tillotson KM, Cleary J: Single-blind randomised controlled trial of chemonucleolysis and manipulation in the treatment of symptomatic lumbar disc herniation. Eur Spine J. 2000, 9: 202-207. 10.1007/s005869900113.PubMedCentralCrossRefPubMed

12.

Licciardone JC, Stoll ST, Fulda KG, Russo DP, Siu J, Winn W, Swift J: Osteopathic manipulative treatment for chronic low back pain: a randomized controlled trial. Spine. 2003, 28: 1355-1362. 10.1097/00007632-200307010-00002.PubMed

13.

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, 20: 662-669. 10.1093/fampra/cmg607.CrossRefPubMed

14.

Licciardone JC, Brimhall AK, King LN: Osteopathic manipulative treatment for low back pain: a systematic review and meta-analysis of randomized controlled trials. BMC Musculoskelet Disord. 2005, 6: 43-10.1186/1471-2474-6-43.PubMedCentralCrossRefPubMed

15.

Resch KL, Schwerla F: Osteopathic manipulative treatment significantly reduces low back pain: systematic review and meta-analysis. Focus Alternat Complement Ther. 2006, 11: 1-

16.

Pensri P, Foster NE, Srisuk S, Baxter GD, McDonough SM: Physiotherapy management of low back pain in Thailand: a study of practice. Physiother Res Int. 2005, 10: 201-212. 10.1002/pri.16.CrossRefPubMed

17.

Poitras S, Blais R, Swaine B, Rossignol M: Management of work-related low back pain: a population-based survey of physical therapists. Phys Ther. 2005, 85: 1168-1181.PubMed

18.

Wright A, Sluka KA: Nonpharmacological treatments for musculoskeletal pain. Clin J Pain. 2001, 17: 33-46. 10.1097/00002508-200103000-00006.CrossRefPubMed

19.

Speed CA: Therapeutic ultrasound in soft tissue lesions. Rheumatology (Oxford). 2001, 40: 1331-1336. 10.1093/rheumatology/40.12.1331.CrossRef

20.

Gam AN, Johannsen F: Ultrasound therapy in musculoskeletal disorders: a meta-analysis. Pain. 1995, 63: 85-91. 10.1016/0304-3959(95)00018-N.CrossRefPubMed

21.

Michlovitz SL, Nolan TP: Modalities for Therapeutic Intervention. 2005, Philadelphia, PA: F.A. Davis Co, 4

22.

Philadelphia Panel evidence-based clinical practice guidelines on selected rehabilitation interventions for low back pain. Phys Ther. 2001, 81: 1641-1674.

23.

Roman MP: A clinical evaluation of ultrasound by use of a placebo technic. Phys Ther Rev. 1960, 40: 649-652.PubMed

24.

Airaksinen O, Brox JI, Cedraschi C, Hildebrandt J, Klaber-Moffett J, Kovacs F, Mannion AF, Reis S, Staal JB, Ursin H, Zanoli G, COST B13 Working Group on Guidelines for Chronic Low Back Pain: Chapter 4. European guidelines for the management of chronic nonspecific low back pain. Eur Spine J. 2006, 15 (Suppl 2): S192-300. 10.1007/s00586-006-1072-1.PubMedCentralCrossRefPubMed

25.

Assendelft WJJ, Morton SC, Yu EI, Suttorp MJ, Shekelle PG: Spinal manipulative therapy for low back pain: a meta-analysis of effectiveness relative to other therapies. Ann Intern Med. 2003, 138: 871-881.CrossRefPubMed

26.

Ware JE, Snow KK, Kosinski M, Gandek B: SF-36 Health Survey: Manual and Interpretation Guide. 1993, Boston, MA: New England Medical Center

27.

Bigos S, Bowyer O, Braen G, et al: Acute Low Back Problems in Adults. Clinical Practice Guideline No. 14. 1994, Rockville, MD: Agency for Healthcare Research and Quality, Public Health Service, U.S. Department of Health and Human Services

28.

Piantadosi S: Clinical Trials: A Methodologic Perspective. 1997, New York: John Wiley & Sons, Inc

29.

Lesho EP: An overview of osteopathic medicine. Arch Fam Med. 1999, 8: 477-484. 10.1001/archfami.8.6.477.CrossRefPubMed

30.

Glossary of osteopathic terminology. Foundations for Osteopathic Medicine. Edited by: Ward RC. 2003, Philadelphia, PA : Lippincott Williams & Wilkins, 1229-1253. 2

31.

Kuchera WA: Lumbar region. Foundations for Osteopathic Medicine. Edited by: Ward RC. 2003, Philadelphia: Lippincott Williams & Wilkins, 727-750. 2

32.

Prentice WE, Quillen WS, Underwood F: Therapeutic Modalities in Rehabilitation. 2005, New York: McGraw-Hill, 3

33.

Licciardone JC, Buchanan S, Fulda KG, Hensel K, King H, Stoll ST: A pilot clinical trial of osteopathic manipulative treatment during third trimester pregnancy (abstract). J Am Osteopath Assoc. 2007, 107: 329-

34.

Bombardier C: Outcome assessments in the evaluation of treatment of spinal disorders: summary and general recommendations. Spine. 2000, 25: 3100-3103. 10.1097/00007632-200012150-00003.CrossRefPubMed

35.

Ogon M, Krismer M, Sollner W, Kantner-Rumplmair W, Lampe A: Chronic low back pain measurement with visual analogue scales in different settings. Pain. 1996, 64: 425-428. 10.1016/0304-3959(95)00208-1.CrossRefPubMed

36.

Roland M, Morris R: A study of the natural history of back pain. Part I: development of a reliable and sensitive measure of disability in low-back pain. Spine. 1983, 8: 141-144. 10.1097/00007632-198303000-00004.CrossRefPubMed

37.

Roland M, Fairbank J: The Roland-Morris Disability Questionnaire and the Oswestry Disability Questionnaire. Spine. 2000, 25: 3115-3124. 10.1097/00007632-200012150-00006.CrossRefPubMed

38.

Stratford PW, Binkley J, Solomon P, Gill C, Finch E: Assessing change over time in patients with low back pain. Phys Ther. 1994, 74: 528-533.PubMed

39.

Ware JE, Gandek B: Overview of the SF-36 health survey and the International Quality of Life Assessment (IQOLA) Project. Journal of Clinical Epidemiology. 1998, 51: 903-912. 10.1016/S0895-4356(98)00081-X.CrossRefPubMed

Title: OSTEOPAThic Health outcomes In Chronic low back pain: The OSTEOPATHIC Trial
Authors: John C Licciardone
Hollis H King
Kendi L Hensel
Daniel G Williams
Publication date: 01-12-2008
Publisher: BioMed Central
Published in: Osteopathic Medicine and Primary Care / Issue 1/2008
Electronic ISSN: 1750-4732
DOI: https://doi.org/10.1186/1750-4732-2-5

Keynote webinar | Spotlight on medication adherence

Springer Medicine

OSTEOPAThic Health outcomes In Chronic low back pain: The OSTEOPATHIC Trial

Abstract

Background

Methods

Conclusion

Trial registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods

Conclusion

Trial registration

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