Low Back Pain Clinical Trial
— HiLoBaSOfficial title:
Does Prescriptive Treatment of the Hips Improve Outcomes in Patients With Low Back Pain? A Randomized Controlled Trial
Verified date | April 2016 |
Source | Regis University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 90 |
Est. completion date | March 2016 |
Est. primary completion date | December 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Regis University | Denver | Colorado |
Lead Sponsor | Collaborator |
---|---|
Regis University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Modified Oswestry Disability Index | The Modified Oswestry Disability Index (ODI) will be used to measure disability, will serve as the primary outcome measure for the study, and consists of 10 questions each scored from 0 to 5, with higher scores indicating greater disability. A 50% reduction in the ODI or greater from baseline has been considered a clinically important outcome. | Baseline, 2 weeks, End of Intervention (Discharge) | No |
Secondary | Change in Numeric Pain Rating Scale | An 11-point NPRS will be used to measure pain intensity. The scale is anchored on the left with the phrase "No Pain" and on the right with the phrase "Worst Possible Pain". NPRSs have been shown to be reliable and valid.32 Patients rate their current level of pain and their worst and least amount of pain experienced during the last 24 hours. | Baseline, 2 weeks, End of Intervention (Discharge) | Yes |
Secondary | Recovery | A recent study has summarized the assortment of definitions associated with recovery.30 Recovery definitions associated with pain have ranged from 1) an absence of pain, to a maximal level of pain (e.g., 2/10 on an 11 point scale). Recovery definitions affiliated with function have included; 1) no functional dysfunction to 2) maximal level of functional loss (e.g., 20%/100% on a disability index). None have defined recovery in terms of a patient's perspective of recovery such as the patient acceptable symptom state (PASS) score. The PASS is the state beyond which patients consider their state as acceptable and are unlikely to seek further treatment.31 Thus, therapeutic success can be defined at the individual level (i.e., for each patient) as an improvement greater than minimum clinically acceptable score, or as achieving a state acceptable at the end of the care.31 For our study, recovery is defined as a "yes" (patients consider their state as acceptable) on the PASS at discharge. | End of Intervention (Discharge) | No |
Secondary | Change in Global Rating of Change Score | The fifteen-point global rating scale described by Jaeschke et al.,33 will be used. The scale ranges from -7 (a very great deal worse) to zero (about the same) to +7 (a very great deal better). The global rating scale will be administered at 4 visits, 1 month, and 6 months. | 2 weeks and End of Intervention (Discharge) | No |
Secondary | Change in Patient Satisfaction | An 11-point patient satisfaction measure will be used to capture the patient's overall satisfaction with their intervention. The scale is anchored on the left with the phrase "Completely Dissatisfied" and on the right with the phrase "Completely Satisfied". | 2 weeks and End of Intervention (Discharge) | No |
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