Phase 3
N=455
Osteopathic Health Outcomes in Chronic Low Back Pain (OSTEOPATHIC) Trial
Low Back Pain
Bottom Line
View on ClinicalTrials.gov: NCT00315120 ↗Enrolled (actual)
455
Serious AEs
2.0%
Results posted
Jul 2016
Primary outcome: Primary: Change in Visual Analogue Scale Score for Pain Over 12 Weeks (OMT vs Sham OMT) — 40; 20 participants — p=0.007
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- A. Active OMT and active UST (Procedure); B. Sham OMT and active UST (Procedure); C. Active OMT and sham UST (Procedure); D. Sham OMT and sham UST (Procedure)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- University of North Texas Health Science Center
- Primary completion
- Jan 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Visual Analogue Scale Score for Pain Over 12 Weeks (OMT vs Sham OMT) |
40; 20 | 0.007 sig |
| PRIMARY Change in Visual Analogue Scale Score for Pain Over 12 Weeks (Active UST vs Sham UST) |
32; 28 | 0.72 |
| SECONDARY Roland Morris Disability Questionnaire (OMT and Sham OMT - Week 4) |
4; 5 | — |
| SECONDARY Roland Morris Disability Questionnaire (OMT and Sham OMT - Week 8) |
3; 3 | — |
| SECONDARY Roland Morris Disability Questionnaire (OMT and Sham OMT - Week 12) |
2; 3 | — |
| SECONDARY Roland Morris Disability Questionnaire (UST and Sham UST - Week 4) |
4; 5 | — |
| SECONDARY Roland Morris Disability Questionnaire (UST and Sham UST - Week 8) |
3; 4 | — |
| SECONDARY Roland Morris Disability Questionnaire (UST and Sham UST - Week 12) |
3; 3 | — |
| SECONDARY Medical Outcomes Study SF-36 Health Survey (OMT and Sham OMT - Week 4) |
71; 72 | — |
| SECONDARY Medical Outcomes Study SF-36 Health Survey (OMT and Sham OMT - Week 8) |
72; 72 | — |
| SECONDARY Medical Outcomes Study SF-36 Health Survey (OMT and Sham OMT - Week 12) |
72; 72 | — |
| SECONDARY Medical Outcomes Study SF-36 Health Survey (UST and Sham UST - Week 4) |
72; 72 | — |
| SECONDARY Medical Outcomes Study SF-36 Health Survey (UST and Sham UST - Week 8) |
72; 72 | — |
| SECONDARY Medical Outcomes Study SF-36 Health Survey (UST and Sham UST - Week 12) |
72; 74 | — |
| SECONDARY Work Disability (OMT and Sham OMT - Week 4) |
11; 14 | — |
| SECONDARY Work Disability (OMT and Sham OMT - Week 8) |
7; 20 | — |
| SECONDARY Work Disability (OMT and Sham OMT - Week 12) |
12; 8 | — |
| SECONDARY Work Disability (UST and Sham UST - Week 4) |
18; 7 | — |
| SECONDARY Work Disability (UST and Sham UST - Week 8) |
19; 8 | — |
| SECONDARY Work Disability (UST and Sham UST - Week 12) |
14; 6 | — |
| SECONDARY Satisfaction With Back Care (OMT and Sham OMT - Week 4) |
109; 71 | — |
| SECONDARY Satisfaction With Back Care (OMT and Sham OMT - Week 8) |
129; 84 | — |
| SECONDARY Satisfaction With Back Care (OMT and Sham OMT - Week 12) |
143; 92 | — |
| SECONDARY Satisfaction With Back Care (UST and Sham UST - Week 4) |
87; 93 | — |
| SECONDARY Satisfaction With Back Care (UST and Sham UST - Week 8) |
107; 106 | — |
| SECONDARY Satisfaction With Back Care (UST and Sham UST - Week 12) |
120; 115 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00315120). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.