Clinical trial NCT00315120: Osteopathic Health Outcomes in Chronic Low Back Pain (OSTEOPATHIC) Trial
Official title: A Randomized Controlled Trial of Osteopathic Manipulative Treatment and Ultrasound Physical Therapy for Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Low Back Pain
Keywords: Randomized controlled trial
Low back pain
Spinal manipulative therapy
Spinal manipulation
Osteopathic manipulation
Osteopathic medicine
Physical therapy modalities
Lead sponsor: University of North Texas Health Science Center
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: Osteopathic Heritage Foundations
name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2006-04-17
Enrollment: 455
Sex: ALL
Minimum age (years): 21
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether osteopathic manipulative treatment (a type of spinal manipulative therapy used by osteopathic physicians) and ultrasound physical therapy are effective in the treatment of chronic low back pain.

Detailed description: The purpose of this study is to determine whether osteopathic manipulative treatment (a type of spinal manipulative therapy used by osteopathic physicians) and ultrasound physical therapy are effective in the treatment of chronic low back pain. This study uses a 2X2 factorial design to test the hypotheses.

Eligibility criteria: Inclusion Criteria:

* Must give a positive response to the question: "Have you had low back pain constantly or on most days for the last three months?"
* Must identify the low back as the primary site of pain
* Must agree to not receive any of the following outside of the study during the period of participation: osteopathic manipulative treatment, chiropractic adjustment (including "mobilization" or "manipulation"), physical therapy
* Women must not be pregnant or plan to become pregnant during the period of study participation (a negative pregnancy test and willingness to maintain an acceptable method of contraception will be required)

Exclusion Criteria:

* History of any of the following conditions which may be underlying causes of low back symptoms: cancer, spinal osteomyelitis, spinal fracture, herniated disc, ankylosing spondylitis, cauda equina syndrome
* History of surgery involving the low back within the past year or planned low back surgery in the future
* History of receiving Workers' Compensation benefits within the past three months
* Involvement in current litigation relating to back problems
* Current pregnancy or plan to become pregnant during the course of participation in the study
* Any of the following that may limit a provider's choice of osteopathic manipulative treatment techniques or hamper compliance with the study protocol: angina or congestive heart failure symptoms that occur at rest or with minimal activity, history of a stroke or transient ischemic attack within the past year
* Any of the following that may represent potential contraindications to receiving ultrasound physical therapy: implantation of a cardiac pacemaker, implantation of artificial joints or other biomedical devices, active bleeding or infection in the low back, pregnancy
* Use of intravenous, intramuscular, or oral corticosteroids within the past month
* History of osteopathic manipulative treatment, chiropractic adjustment, or physical therapy within the past three months or on more than three occasions during the past year
* Practitioner or student of any of the following: osteopathic medicine (D.O.) allopathic medicine (M.D.), chiropractic (D.C.), physical therapy

Primary outcomes:
measure: Change in Visual Analogue Scale Score for Pain Over 12 Weeks (OMT vs Sham OMT)
timeFrame: 12 weeks
measure: Change in Visual Analogue Scale Score for Pain Over 12 Weeks (Active UST vs Sham UST)
timeFrame: 12 weeks
Secondary outcomes:
measure: Roland Morris Disability Questionnaire (OMT and Sham OMT - Week 4)
timeFrame: 4 weeks
measure: Roland Morris Disability Questionnaire (OMT and Sham OMT - Week 8)
timeFrame: 8 weeks
measure: Roland Morris Disability Questionnaire (OMT and Sham OMT - Week 12)
timeFrame: 12 weeks
measure: Roland Morris Disability Questionnaire (UST and Sham UST - Week 4)
timeFrame: 4 weeks
measure: Roland Morris Disability Questionnaire (UST and Sham UST - Week 8)
timeFrame: 8 weeks
measure: Roland Morris Disability Questionnaire (UST and Sham UST - Week 12)
timeFrame: 12 weeks
measure: Medical Outcomes Study SF-36 Health Survey (OMT and Sham OMT - Week 4)
timeFrame: 4 weeks
measure: Medical Outcomes Study SF-36 Health Survey (OMT and Sham OMT - Week 8)
timeFrame: 8 weeks
measure: Medical Outcomes Study SF-36 Health Survey (OMT and Sham OMT - Week 12)
timeFrame: 12 weeks
measure: Medical Outcomes Study SF-36 Health Survey (UST and Sham UST - Week 4)
timeFrame: 4 Weeks
measure: Medical Outcomes Study SF-36 Health Survey (UST and Sham UST - Week 8)
timeFrame: 8 Weeks
measure: Medical Outcomes Study SF-36 Health Survey (UST and Sham UST - Week 12)
timeFrame: 12 Weeks
measure: Work Disability (OMT and Sham OMT - Week 4)
timeFrame: 4 weeks
measure: Work Disability (OMT and Sham OMT - Week 8)
timeFrame: 8 weeks
measure: Work Disability (OMT and Sham OMT - Week 12)
timeFrame: 12 weeks
measure: Work Disability (UST and Sham UST - Week 4)
timeFrame: 4 weeks
measure: Work Disability (UST and Sham UST - Week 8)
timeFrame: 8 weeks
measure: Work Disability (UST and Sham UST - Week 12)
timeFrame: 12 weeks
measure: Satisfaction With Back Care (OMT and Sham OMT - Week 4)
timeFrame: 4 weeks
measure: Satisfaction With Back Care (OMT and Sham OMT - Week 8)
timeFrame: 8 weeks
measure: Satisfaction With Back Care (OMT and Sham OMT - Week 12)
timeFrame: 12 weeks
measure: Satisfaction With Back Care (UST and Sham UST - Week 4)
timeFrame: 4 weeks
measure: Satisfaction With Back Care (UST and Sham UST - Week 8)
timeFrame: 8 weeks
measure: Satisfaction With Back Care (UST and Sham UST - Week 12)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: The Osteopathic Research Center
state: Texas
Study officials:
affiliation: The Osteopathic Research Center, University of North Texas Health Science Center at Fort Worth
name: John C. Licciardone, DO, MS, MBA
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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 Aug 4;6:43. doi: 10.1186/1471-2474-6-43.
citation: Licciardone JC, King HH, Hensel KL, Williams DG. OSTEOPAThic Health outcomes in chronic low back pain: The OSTEOPATHIC Trial. Osteopath Med Prim Care. 2008 Apr 25;2:5. doi: 10.1186/1750-4732-2-5.
citation: Clinical Guideline Subcommittee on Low Back Pain; American Osteopathic Association. American Osteopathic Association guidelines for osteopathic manipulative treatment (OMT) for patients with low back pain. J Am Osteopath Assoc. 2010 Nov;110(11):653-66.
citation: Licciardone JC, Gatchel R, Dagenais S. Assessment and management of back pain. JAMA Intern Med. 2014 Mar;174(3):478-9. doi: 10.1001/jamainternmed.2013.13692. No abstract available.
citation: Licciardone JC. Osteopathic manual treatment and ultrasound therapy for chronic low back pain: an illustration of osteopathic semantic confusion. Author reply. J Am Osteopath Assoc. 2013 Sep;113(9):661-2. doi: 10.7556/jaoa.2013.031. No abstract available.
citation: Licciardone JC. Systematic review and meta-analysis conclusions relating to osteopathic manipulative treatment for low back pain remain valid and well accepted. J Bodyw Mov Ther. 2013 Jan;17(1):2-4. doi: 10.1016/j.jbmt.2012.10.003. Epub 2012 Nov 16. No abstract available.
citation: Licciardone JC. Osteopathic manipulative treatment in patients with low back pain. Clin Rheumatol. 2011 Jun;30(6):871-2; author reply 873. doi: 10.1007/s10067-011-1739-9. Epub 2011 Apr 15. No abstract available.
citation: Licciardone JC, Kearns CM, Minotti DE. Outcomes of osteopathic manual treatment for chronic low back pain according to baseline pain severity: results from the OSTEOPATHIC Trial. Man Ther. 2013 Dec;18(6):533-40. doi: 10.1016/j.math.2013.05.006. Epub 2013 Jun 10.
citation: Licciardone JC, Kearns CM, Hodge LM, Minotti DE. Osteopathic manual treatment in patients with diabetes mellitus and comorbid chronic low back pain: subgroup results from the OSTEOPATHIC Trial. J Am Osteopath Assoc. 2013 Jun;113(6):468-78.
citation: Licciardone JC, Minotti DE, Gatchel RJ, Kearns CM, Singh KP. Osteopathic manual treatment and ultrasound therapy for chronic low back pain: a randomized controlled trial. Ann Fam Med. 2013 Mar-Apr;11(2):122-9. doi: 10.1370/afm.1468.
citation: Licciardone JC, Gatchel RJ, Kearns CM, Minotti DE. Depression, somatization, and somatic dysfunction in patients with nonspecific chronic low back pain: results from the OSTEOPATHIC Trial. J Am Osteopath Assoc. 2012 Dec;112(12):783-91.
citation: Licciardone JC, Kearns CM, Hodge LM, Bergamini MV. Associations of cytokine concentrations with key osteopathic lesions and clinical outcomes in patients with nonspecific chronic low back pain: results from the OSTEOPATHIC Trial. J Am Osteopath Assoc. 2012 Sep;112(9):596-605. doi: 10.7556/jaoa.2012.112.9.596.
citation: Licciardone JC, Kearns CM. Somatic dysfunction and its association with chronic low back pain, back-specific functioning, and general health: results from the OSTEOPATHIC Trial. J Am Osteopath Assoc. 2012 Jul;112(7):420-8.
citation: Licciardone JC. Short-term dosing of manual therapies for chronic low back pain. Spine J. 2014 Jun 1;14(6):1085-6. doi: 10.1016/j.spinee.2013.12.015. Epub 2013 Dec 20. No abstract available.
citation: Licciardone JC, Kearns CM, Crow WT. Changes in biomechanical dysfunction and low back pain reduction with osteopathic manual treatment: results from the OSTEOPATHIC Trial. Man Ther. 2014 Aug;19(4):324-30. doi: 10.1016/j.math.2014.03.004. Epub 2014 Mar 18.
citation: Licciardone JC. The OSTEOPATHIC trial demonstrates significant improvement in patients with chronic low back pain as manifested by decreased prescription rescue medication use. J Am Osteopath Assoc. 2014 Jul;114(7):528-9. doi: 10.7556/jaoa.2014.103. No abstract available.
citation: Licciardone JC, Aryal S. Clinical response and relapse in patients with chronic low back pain following osteopathic manual treatment: results from the OSTEOPATHIC Trial. Man Ther. 2014 Dec;19(6):541-8. doi: 10.1016/j.math.2014.05.012. Epub 2014 Jun 5.
citation: Licciardone JC, Gatchel RJ, Aryal S. Targeting Patient Subgroups With Chronic Low Back Pain for Osteopathic Manipulative Treatment: Responder Analyses From a Randomized Controlled Trial. J Am Osteopath Assoc. 2016 Mar;116(3):156-68. doi: 10.7556/jaoa.2016.032.
citation: Licciardone JC, Gatchel RJ, Aryal S. Recovery From Chronic Low Back Pain After Osteopathic Manipulative Treatment: A Randomized Controlled Trial. J Am Osteopath Assoc. 2016 Mar;116(3):144-55. doi: 10.7556/jaoa.2016.031.