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

Study Overview
=================
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.

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

Conditions
-----------------
Low Back Pain

Intervention / Treatment
-----------------
* Procedure: 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


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 69 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: A (Active OMT and active (UST)<br>Subjects in this group received active osteopathic manipulation and active ultrasound physical therapy | Procedure: A. Active OMT and active UST<br>* Active osteopathic manipulation (OMT) and active ultrasound physical therapy (UST)<br>|
| Other: B (Sham OMT and active UST)<br>Subjects in this group received sham osteopathic manipulation and active ultrasound physical therapy | Procedure: B. Sham OMT and active UST<br>* Sham osteopathic manipulation (OMT) and active ultrasound physical therapy (UST)<br>|
| Other: C (Active OMT and sham UST)<br>Subjects in this group received active osteopathic manipulation and sham ultrasound physical therapy | Procedure: C. Active OMT and sham UST<br>* Active osteopathic manipulation (OMT) and sham ultrasound physical therapy (UST)<br>|
| Other: D (Sham OMT and sham UST)<br>Subjects in this group received sham osteopathic manipulation and sham ultrasound physical therapy | Procedure: D. Sham OMT and sham UST<br>* Sham osteopathic manipulation (OMT) and sham ultrasound physical therapy (UST)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Randomized controlled trial, Low back pain, Spinal manipulative therapy, Spinal manipulation, Osteopathic manipulation, Osteopathic medicine, Physical therapy modalities