CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 455 enrolled
Drug / intervention
A. Active OMT and active UST +3 moreprocedure
Likely dose
Not stated in record
Key inclusion· 3
  • ✓Chronic low back pain for ≥3 months, constantly or on most days
  • ✓Low back must be identified as the primary site of pain
  • ✓Agreement to not receive osteopathic manipulative treatment, chiropractic adjustment, physical therapy, or mobilization/manipulation outside the study during participation
Key exclusion· 11
  • ✕History of spinal conditions that may underlie low back symptoms: cancer, spinal osteomyelitis, spinal fracture, herniated disc, ankylosing spondylitis, or cauda equina syndrome
  • ✕Low back surgery within the past year or planned future low back surgery
  • ✕Workers' compensation benefits within the past 3 months
  • ✕Current litigation relating to back problems

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00315120
NCT00315120Phase 3Completed
CompareCT.gov

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

University of North Texas Health Science Center·interventional·Posted Apr 17, 2006·Updated Jul 6, 2016

In Brief

A Phase 3 clinical trial evaluating A. Active OMT and active UST, B. Sham OMT and active UST, and 2 other interventions for Low Back Pain. Completed, enrolled 455 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLow Back Pain
CountriesUnited States
CollaboratorsNational Institutes of Health (NIH), Osteopathic Heritage Foundations, National Center for Complementary and Integrative Health (NCCIH)

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 17, 2006
Enrollment StartAug 1, 2006
Primary CompletionJan 1, 2011
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 20.2 years ago

Interventions

A. Active OMT and active USTprocedure

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

B. Sham OMT and active USTprocedure

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

C. Active OMT and sham USTprocedure

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

D. Sham OMT and sham USTprocedure

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