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

Phase 3

Completed

Conditions: Low Back Pain

Registration Number: NCT00315120

Lead Sponsor: University of North Texas Health Science Center

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 455

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

Study Type: INTERVENTIONAL

Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Change in Visual Analogue Scale Score for Pain Over 12 Weeks (OMT vs Sham OMT)	12 weeks	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%).
Change in Visual Analogue Scale Score for Pain Over 12 Weeks (Active UST vs Sham UST)	12 weeks	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%).

Secondary Outcome Measures

Name	Time	Method
Roland Morris Disability Questionnaire (OMT and Sham OMT - Week 4)	4 weeks	Overall scores range from 0 to 24, which higher scores representing greater deficits in back-specific functioning.
Roland Morris Disability Questionnaire (UST and Sham UST - Week 12)	12 weeks	Overall scores range from 0 to 24, which higher scores representing greater deficits in back-specific functioning.
Roland Morris Disability Questionnaire (UST and Sham UST - Week 4)	4 weeks	Overall scores range from 0 to 24, which higher scores representing greater deficits in back-specific functioning.
Medical Outcomes Study SF-36 Health Survey (OMT and Sham OMT - Week 4)	4 weeks	The general health scale ranges from 0 to 100, with higher scores representing better general health.
Work Disability (OMT and Sham OMT - Week 12)	12 weeks	Number of participants who reported losing one or more work days in the past 4 weeks because of low back pain.
Roland Morris Disability Questionnaire (OMT and Sham OMT - Week 8)	8 weeks	Overall scores range from 0 to 24, which higher scores representing greater deficits in back-specific functioning.
Roland Morris Disability Questionnaire (OMT and Sham OMT - Week 12)	12 weeks	Overall scores range from 0 to 24, which higher scores representing greater deficits in back-specific functioning.
Medical Outcomes Study SF-36 Health Survey (OMT and Sham OMT - Week 12)	12 weeks	The general health scale ranges from 0 to 100, with higher scores representing better general health.
Work Disability (OMT and Sham OMT - Week 4)	4 weeks	Number of participants who reported losing one or more work days in the past 4 weeks because of low back pain.
Work Disability (UST and Sham UST - Week 4)	4 weeks	Number of participants who reported losing one or more work days in the past 4 weeks because of low back pain.
Work Disability (UST and Sham UST - Week 8)	8 weeks	Number of participants who reported losing one or more work days in the past 4 weeks because of low back pain.
Satisfaction With Back Care (OMT and Sham OMT - Week 12)	12 weeks	Subjects who reported being very satisfied with back care
Roland Morris Disability Questionnaire (UST and Sham UST - Week 8)	8 weeks	Overall scores range from 0 to 24, which higher scores representing greater deficits in back-specific functioning.
Medical Outcomes Study SF-36 Health Survey (UST and Sham UST - Week 8)	8 Weeks	The general health scale ranges from 0 to 100, with higher scores representing better general health.
Work Disability (OMT and Sham OMT - Week 8)	8 weeks	Number of participants who reported losing one or more work days in the past 4 weeks because of low back pain.
Satisfaction With Back Care (OMT and Sham OMT - Week 4)	4 weeks	Subjects who reported being very satisfied with back care
Satisfaction With Back Care (UST and Sham UST - Week 4)	4 weeks	Subjects who reported being very satisfied with back care
Medical Outcomes Study SF-36 Health Survey (OMT and Sham OMT - Week 8)	8 weeks	The general health scale ranges from 0 to 100, with higher scores representing better general health.
Medical Outcomes Study SF-36 Health Survey (UST and Sham UST - Week 4)	4 Weeks	The general health scale ranges from 0 to 100, with higher scores representing better general health.
Satisfaction With Back Care (UST and Sham UST - Week 8)	8 weeks	Subjects who reported being very satisfied with back care
Medical Outcomes Study SF-36 Health Survey (UST and Sham UST - Week 12)	12 Weeks	The general health scale ranges from 0 to 100, with higher scores representing better general health.
Work Disability (UST and Sham UST - Week 12)	12 weeks	Number of participants who reported losing one or more work days in the past 4 weeks because of low back pain.
Satisfaction With Back Care (OMT and Sham OMT - Week 8)	8 weeks	Subjects who reported being very satisfied with back care
Satisfaction With Back Care (UST and Sham UST - Week 12)	12 weeks	Subjects who reported being very satisfied with back care

Trial Locations

Locations (1): The Osteopathic Research Center
🇺🇸
Fort Worth, Texas, United States
The Osteopathic Research Center
🇺🇸Fort Worth, Texas, United States