Osteopathic Health Outcomes in Chronic Low Back Pain (OSTEOPATHIC) Trial

NCT00315120 | Completed Phase 3 Results DMC

• 2 other identifiers: 06-02-20-1K24AT002422
• Study Type: interventional
• Target: 455
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Keywords

Randomized controlled trial; Low back pain; Spinal manipulative therapy; Spinal manipulation; Osteopathic manipulation; Osteopathic medicine; Physical therapy modalities

Outcome Measures

Primary Outcomes (2)

• Change in Visual Analogue Scale Score for Pain Over 12 Weeks (OMT vs Sham OMT)

  Comparison of the number (proportion) of participants in each study group who achieve a substantial improvement in low back pain over 12 weeks as determined by at least a 40-mm reduction (-40 mm) on the visual analogue scale score for pain compared with the baseline score. Changes in the visual analogue scale scores for pain over 12 weeks may potentially range from a 100-mm reduction (-100 mm) to a 100-mm increase (+100). Any reduction (negative score) represents an improvement in low back pain (i.e., a "better" outcome), while any increase (positive score) represents a worsening of low back pain (i.e., a "worse" outcome). However, only those "better" outcomes represented by change scores less than or equal to -40 mm are considered to represent substantial improvement in low back pain, which is the primary outcome measure of this study. For analyses wherein floor effects are important, the 40-mm reduction threshold for substantial improvement may be replaced by 50% reduction (-50%).

  12 weeks

• Change in Visual Analogue Scale Score for Pain Over 12 Weeks (Active UST vs Sham UST)

  Comparison of the number (proportion) of participants in each study group who achieve a substantial improvement in low back pain over 12 weeks as determined by at least a 40-mm reduction (-40 mm) on the visual analogue scale score for pain compared with the baseline score. Changes in the visual analogue scale scores for pain over 12 weeks may potentially range from a 100-mm reduction (-100 mm) to a 100-mm increase (+100). Any reduction (negative score) represents an improvement in low back pain (i.e., a "better" outcome), while any increase (positive score) represents a worsening of low back pain (i.e., a "worse" outcome). However, only those "better" outcomes represented by change scores less than or equal to -40 mm are considered to represent substantial improvement in low back pain, which is the primary outcome measure of this study. For analyses wherein floor effects are important, the 40-mm reduction threshold for substantial improvement may be replaced by 50% reduction (-50%).

  12 weeks

Secondary Outcomes (24)

• Roland Morris Disability Questionnaire (OMT and Sham OMT - Week 4)

  4 weeks

• Roland Morris Disability Questionnaire (OMT and Sham OMT - Week 8)

  8 weeks

• Roland Morris Disability Questionnaire (OMT and Sham OMT - Week 12)

  12 weeks

• Roland Morris Disability Questionnaire (UST and Sham UST - Week 4)

  4 weeks

• Roland Morris Disability Questionnaire (UST and Sham UST - Week 8)

  8 weeks

Study Arms (4)

A (Active OMT and active (UST)

OTHER

Subjects in this group received active osteopathic manipulation and active ultrasound physical therapy

Procedure: A. Active OMT and active UST

B (Sham OMT and active UST)

OTHER

Subjects in this group received sham osteopathic manipulation and active ultrasound physical therapy

Procedure: B. Sham OMT and active UST

C (Active OMT and sham UST)

OTHER

Subjects in this group received active osteopathic manipulation and sham ultrasound physical therapy

Procedure: C. Active OMT and sham UST

D (Sham OMT and sham UST)

OTHER

Subjects in this group received sham osteopathic manipulation and sham ultrasound physical therapy

Procedure: D. Sham OMT and sham UST

Interventions

A. Active OMT and active UST PROCEDURE

Active osteopathic manipulation (OMT) and active ultrasound physical therapy (UST)

A (Active OMT and active (UST)

B. Sham OMT and active UST PROCEDURE

Sham osteopathic manipulation (OMT) and active ultrasound physical therapy (UST)

B (Sham OMT and active UST)

C. Active OMT and sham UST PROCEDURE

Active osteopathic manipulation (OMT) and sham ultrasound physical therapy (UST)

C (Active OMT and sham UST)

D. Sham OMT and sham UST PROCEDURE

Sham osteopathic manipulation (OMT) and sham ultrasound physical therapy (UST)

D (Sham OMT and sham UST)

Eligibility Criteria

• Age: 21 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Texas Health Science Center: lead
• National Institutes of Health (NIH): collaborator
• Osteopathic Heritage Foundations: collaborator
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

The Osteopathic Research Center

Fort Worth, Texas, 76107, United States

Location

Related Publications (19)

• 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.

  PMID: 16080794 BACKGROUND

• 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.

  PMID: 18439282 BACKGROUND

• 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.

  PMID: 21135197 BACKGROUND

• 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.

  PMID: 24590092 BACKGROUND

• 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.

  PMID: 24133757 BACKGROUND

• 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.

  PMID: 23294676 BACKGROUND

• 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.

  PMID: 21494808 BACKGROUND

• 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.

  PMID: 23759340 RESULT

• 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.

  PMID: 23739758 RESULT

• 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.

  PMID: 23508598 RESULT

• 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.

  PMID: 23212429 RESULT

• 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.

  PMID: 22984233 RESULT

• 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.

  PMID: 22802542 RESULT

• 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.

  PMID: 24361999 RESULT

• 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.

  PMID: 24704126 RESULT

• 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.

  PMID: 25002440 RESULT

• 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.

  PMID: 24965494 RESULT

• 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.

  PMID: 26927909 DERIVED

• 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.

  PMID: 26927908 DERIVED

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Co-morbid conditions, work disability and low back pain co-treatments were self reported by participants, but were not verified through medical or employment records. Missing data were imputed for 13% of participants at the final encounter.

Results Point of Contact

• Title: John C. Licciardone, DO, MS, MBA
• Organization: University of North Texas Health Science Center-The Osteopathic Research Center

john.licciardone@unthsc.edu

817-735-2028

Study Officials

• John C. Licciardone, DO, MS, MBA

  The Osteopathic Research Center, University of North Texas Health Science Center at Fort Worth

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Osteopathic Research Center

Study Record Dates

• First Submitted: April 13, 2006
• First Posted: April 17, 2006
• Study Start: August 1, 2006
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: July 6, 2016
• Results First Posted: July 6, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)