Recruitment

Recruitment Status
Completed
Estimated Enrollment
112

Inclusion Criterias

18 years of age or older
Minimum baseline pain score of >2.0/10 on the numeric analog scale for pain
Minimum Modified Oswestry Disability Index score of 20%
...
18 years of age or older
Minimum baseline pain score of >2.0/10 on the numeric analog scale for pain
Minimum Modified Oswestry Disability Index score of 20%
Mechanically producible LBP.

Exclusion Criterias

Prior surgery to the lumbar spine
Presence of any red flags
Signs consistent with nerve root compression
...
Prior surgery to the lumbar spine
Presence of any red flags
Signs consistent with nerve root compression
Current pregnancy

Summary

Conditions
Low Back Pain
Type
Interventional
Phase
Phase 2 & Phase 3
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

It has been suggested that treatment of the hips should improve outcomes in patients with mechanical low back pain. This has yet to be studied in a randomized controlled fashion or in a conservative venue. For this study, there will be two groups of patients with low back pain (by randomization). Fo...

It has been suggested that treatment of the hips should improve outcomes in patients with mechanical low back pain. This has yet to be studied in a randomized controlled fashion or in a conservative venue. For this study, there will be two groups of patients with low back pain (by randomization). For inclusion into the randomized clinical trial, patients will need to be 18 years of age or older with mechanically producible LBP. They will require a minimum Modified Oswestry Disability Index score of 20% and a baseline pain score of >2.0/10 on the numeric analog scale for pain, and a within session change (improvement during the visit) in pain and/or range of motion during the assessment phase of the clinical examination. This finding has been advocated as an effective mechanism to determine if a patient is a candidate for manual therapy. Exclusion criteria will include the presence of any red flags (i.e., tumor, metabolic diseases, rheumatoid arthritis, osteoporosis, prolonged history of steroid use, etc.), or signs consistent with nerve root compression (reproduction of low back or leg pain with straight leg raise at less than 45°, muscle weakness involving a major muscle group of the lower extremity, diminished lower extremity muscle stretch reflex, or diminished or absent sensation to pinprick in any lower extremity dermatome). Other exclusion criteria include prior surgery to the lumbar spine and current pregnancy. Both groups will receive a pragmatic treatment approach by physical therapists for low back pain. One group will also receive a prescriptive treatment approach for both hips. The investigators will track the outcomes of disability (Oswestry), Pain (Numeric pain rating scale), and recovery at baseline, 2 weeks, and discharge. Our aims are to determine if differences in groups exist, with our primary outcome measure of ODI. The investigators feel that the additional of a standardized exercise program and stretching for the hips will improve outcomes in patients with mechanical low back pain.

Inclusion Criterias

18 years of age or older
Minimum baseline pain score of >2.0/10 on the numeric analog scale for pain
Minimum Modified Oswestry Disability Index score of 20%
...
18 years of age or older
Minimum baseline pain score of >2.0/10 on the numeric analog scale for pain
Minimum Modified Oswestry Disability Index score of 20%
Mechanically producible LBP.

Exclusion Criterias

Prior surgery to the lumbar spine
Presence of any red flags
Signs consistent with nerve root compression
...
Prior surgery to the lumbar spine
Presence of any red flags
Signs consistent with nerve root compression
Current pregnancy

Locations

Denver, Colorado, 80221
Denver, Colorado, 80221

Tracking Information

NCT #
NCT01900925
Collaborators
Not Provided
Investigators
  • Principal Investigator: Michael J Bade, PhD, PT Regis University
  • Michael J Bade, PhD, PT Regis University