Clinical trial NCT01900925: Does Prescriptive Treatment of the Hips Improve Outcomes in Patients With Low Back Pain? A Randomized Controlled Trial
Official title: Does Prescriptive Treatment of the Hips Improve Outcomes in Patients With Low Back Pain? A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Low Back Pain
Keywords: Low back pain, non-specific low back pain
Lead sponsor: Regis University
Sponsor class: OTHER
First posted: 2013-07-17
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: There will be two groups of patients with low back pain (by randomization). 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 feel that the additional of a standardized exercise program and stretching for the hips will improve outcomes in patients with mechanical low back pain.

Detailed 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). 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Change in Modified Oswestry Disability Index
timeFrame: Baseline, 2 weeks, End of Intervention (Discharge)
Secondary outcomes:
measure: Change in Numeric Pain Rating Scale
timeFrame: Baseline, 2 weeks, End of Intervention (Discharge)
measure: Recovery
timeFrame: End of Intervention (Discharge)
measure: Change in Global Rating of Change Score
timeFrame: 2 weeks and End of Intervention (Discharge)
measure: Change in Patient Satisfaction
timeFrame: 2 weeks and End of Intervention (Discharge)
Other outcomes:
Locations:
city: Denver
country: United States
facility: Regis University
state: Colorado
Study officials:
affiliation: Regis University
name: Michael J Bade, PhD, PT
role: PRINCIPAL_INVESTIGATOR
References: