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

University of North Texas Health Science Center

Status and phase: Completed; Phase 3

Conditions: Low Back Pain

Treatments: Procedure: B. Sham OMT and active UST; Procedure: D. Sham OMT and sham UST; Procedure: C. Active OMT and sham UST; Procedure: A. Active OMT and active UST

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00315120

06-02-20-1

K24AT002422 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 455 patients

Sex: All

Ages: 21 to 69 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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455 participants in 4 patient groups

A (Active OMT and active (UST)

Other group

Description:

Subjects in this group received active osteopathic manipulation and active ultrasound physical therapy

Treatment:

Procedure: A. Active OMT and active UST

B (Sham OMT and active UST)

Other group

Description:

Subjects in this group received sham osteopathic manipulation and active ultrasound physical therapy

Treatment:

Procedure: B. Sham OMT and active UST

C (Active OMT and sham UST)

Other group

Description:

Subjects in this group received active osteopathic manipulation and sham ultrasound physical therapy

Treatment:

Procedure: C. Active OMT and sham UST

D (Sham OMT and sham UST)

Other group

Description:

Subjects in this group received sham osteopathic manipulation and sham ultrasound physical therapy

Treatment:

Procedure: D. Sham OMT and sham UST