The OSTEOPATHIC Trial: The OSTEOPAThic Health Outcomes In Chronic Low Back Pain Trial

Low Back Pain Clinical Trial

Official title:

A Randomized Controlled Trial of Osteopathic Manipulative Treatment and Ultrasound Physical Therapy for Chronic Low Back Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00315120
• Other study ID #: 06-02-20-1
• Secondary ID: NIH grant no.: K
• Status: Completed
• Phase: Phase 3
• First received: April 13, 2006
• Last updated: May 9, 2011
• Start date: August 2006
• Est. completion date: January 2011

Study information

• Verified date: May 2011
• Source: University of North Texas Health Science Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 488
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 69 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Procedure:
• Active osteopathic manipulation and active ultrasound physical therapy
Active osteopathic manipulation and active ultrasound physical therapy
• Sham osteopathic manipulation and active ultrasound physical therapy
Sham osteopathic manipulation and active ultrasound physical therapy
• Active osteopathic manipulation and sham ultrasound physical therapy
Active osteopathic manipulation and sham ultrasound physical therapy
• Sham osteopathic manipulation and sham ultrasound physical therapy
Sham osteopathic manipulation and sham ultrasound physical therapy

Locations

Country	Name	City	State
United States	The Osteopathic Research Center	Fort Worth	Texas

Sponsors (3)

Lead Sponsor	Collaborator
University of North Texas Health Science Center	National Institutes of Health (NIH), Osteopathic Heritage Foundations

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual analogue scale score for pain		1, 2, 4, 8, 12 weeks	No
Secondary	Roland Morris Disability Questionnaire		4, 8, 12 weeks	No
Secondary	Medical Outcomes Study SF-36 Health Survey		4, 8, 12 weeks	No
Secondary	Work disability		4, 8, 12 weeks	No
Secondary	Satisfaction with back care		4, 8, 12 weeks	No