Skip to main content
OpenTrials
Completed

NCT Number: NCT00315120

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

21 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The Osteopathic Research Center

Fort Worth, Texas, 76107, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

A. Active OMT and active UST

Procedure

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

B. Sham OMT and active UST

Procedure

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

C. Active OMT and sham UST

Procedure

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

D. Sham OMT and sham UST

Procedure

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

Primary outcomes

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

    Time frame: 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%).

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

    Time frame: 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 outcomes

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

    Time frame: 4 weeks

    Overall scores range from 0 to 24, which higher scores representing greater deficits in back-specific functioning.

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

    Time frame: 8 weeks

    Overall scores range from 0 to 24, which higher scores representing greater deficits in back-specific functioning.

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

    Time frame: 12 weeks

    Overall scores range from 0 to 24, which higher scores representing greater deficits in back-specific functioning.

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

    Time frame: 4 weeks

    Overall scores range from 0 to 24, which higher scores representing greater deficits in back-specific functioning.

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

    Time frame: 8 weeks

    Overall scores range from 0 to 24, which higher scores representing greater deficits in back-specific functioning.

  6. Roland Morris Disability Questionnaire (UST and Sham UST - Week 12)

    Time frame: 12 weeks

    Overall scores range from 0 to 24, which higher scores representing greater deficits in back-specific functioning.

  7. Medical Outcomes Study SF-36 Health Survey (OMT and Sham OMT - Week 4)

    Time frame: 4 weeks

    The general health scale ranges from 0 to 100, with higher scores representing better general health.

  8. Medical Outcomes Study SF-36 Health Survey (OMT and Sham OMT - Week 8)

    Time frame: 8 weeks

    The general health scale ranges from 0 to 100, with higher scores representing better general health.

  9. Medical Outcomes Study SF-36 Health Survey (OMT and Sham OMT - Week 12)

    Time frame: 12 weeks

    The general health scale ranges from 0 to 100, with higher scores representing better general health.

  10. Medical Outcomes Study SF-36 Health Survey (UST and Sham UST - Week 4)

    Time frame: 4 Weeks

    The general health scale ranges from 0 to 100, with higher scores representing better general health.

  11. Medical Outcomes Study SF-36 Health Survey (UST and Sham UST - Week 8)

    Time frame: 8 Weeks

    The general health scale ranges from 0 to 100, with higher scores representing better general health.

  12. Medical Outcomes Study SF-36 Health Survey (UST and Sham UST - Week 12)

    Time frame: 12 Weeks

    The general health scale ranges from 0 to 100, with higher scores representing better general health.

  13. Work Disability (OMT and Sham OMT - Week 4)

    Time frame: 4 weeks

    Number of participants who reported losing one or more work days in the past 4 weeks because of low back pain.

  14. Work Disability (OMT and Sham OMT - Week 8)

    Time frame: 8 weeks

    Number of participants who reported losing one or more work days in the past 4 weeks because of low back pain.

  15. Work Disability (OMT and Sham OMT - Week 12)

    Time frame: 12 weeks

    Number of participants who reported losing one or more work days in the past 4 weeks because of low back pain.

  16. Work Disability (UST and Sham UST - Week 4)

    Time frame: 4 weeks

    Number of participants who reported losing one or more work days in the past 4 weeks because of low back pain.

  17. Work Disability (UST and Sham UST - Week 8)

    Time frame: 8 weeks

    Number of participants who reported losing one or more work days in the past 4 weeks because of low back pain.

  18. Work Disability (UST and Sham UST - Week 12)

    Time frame: 12 weeks

    Number of participants who reported losing one or more work days in the past 4 weeks because of low back pain.

  19. Satisfaction With Back Care (OMT and Sham OMT - Week 4)

    Time frame: 4 weeks

    Subjects who reported being very satisfied with back care

  20. Satisfaction With Back Care (OMT and Sham OMT - Week 8)

    Time frame: 8 weeks

    Subjects who reported being very satisfied with back care

  21. Satisfaction With Back Care (OMT and Sham OMT - Week 12)

    Time frame: 12 weeks

    Subjects who reported being very satisfied with back care

  22. Satisfaction With Back Care (UST and Sham UST - Week 4)

    Time frame: 4 weeks

    Subjects who reported being very satisfied with back care

  23. Satisfaction With Back Care (UST and Sham UST - Week 8)

    Time frame: 8 weeks

    Subjects who reported being very satisfied with back care

  24. Satisfaction With Back Care (UST and Sham UST - Week 12)

    Time frame: 12 weeks

    Subjects who reported being very satisfied with back care

Sponsors and collaborators

Lead sponsor

University of North Texas Health Science Center

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)
  • National Institutes of Health (NIH)
  • Osteopathic Heritage Foundations

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2011
Study completion
2011
First posted
Apr 17, 2006
Registry last updated
Jul 6, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.