Does Prescriptive Treatment of the Hips Improve Outcomes in Patients With Low Back Pain? A Randomized Controlled Trial (HiLoBaS)
|ClinicalTrials.gov Identifier: NCT01900925|
Recruitment Status : Completed
First Posted : July 17, 2013
Last Update Posted : May 2, 2016
|Condition or disease||Intervention/treatment||Phase|
|Low Back Pain||Procedure: Prescriptive Hip Exercises and Manual Therapy techniques Procedure: Pragmatic low back pain treatment||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Does Prescriptive Treatment of the Hips Improve Outcomes in Patients With Low Back Pain? A Randomized Controlled Trial|
|Study Start Date :||September 2013|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||March 2016|
Active Comparator: Low back treatment only (pragmatic)
Procedure: Pragmatic low back pain treatment
Other Name: Low back pain treatment
Experimental: LBP treatment and Hip treatment
Group two will receive the same pragmatically applied, guideline-oriented treatment that is recommended from group 1. In addition, group 2 will receive prescriptive hip exercises that include 1) Clam Abduction exercises in sidelying, 2) Hip extension in quadruped, 3) a unilateral bridge, and the manual therapy treatment techniques of; 1) anterior to posterior mobilization of the hip with distraction, 2) long axis distraction of the hip and 3) posterior-anterior mobilization of the hip in prone.26 (See Appendix A for photos of the techniques and descriptions)
Procedure: Prescriptive Hip Exercises and Manual Therapy techniques
1) Clam Abduction exercises in sidelying, 2) Hip extension in quadruped, 3) a unilateral bridge,and; 1) anterior to posterior mobilization of the hip with distraction, 2) long axis distraction of the hip and 3) posterior-anterior mobilization of the hip in proneProcedure: Pragmatic low back pain treatment
Other Name: Low back pain treatment
- Change in Modified Oswestry Disability Index [ Time Frame: Baseline, 2 weeks, End of Intervention (Discharge) ]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.
- Change in Numeric Pain Rating Scale [ Time Frame: Baseline, 2 weeks, End of Intervention (Discharge) ]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.
- Recovery [ Time Frame: End of Intervention (Discharge) ]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.
- Change in Global Rating of Change Score [ Time Frame: 2 weeks and End of Intervention (Discharge) ]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.
- Change in Patient Satisfaction [ Time Frame: 2 weeks and End of Intervention (Discharge) ]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".
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01900925
|United States, Colorado|
|Denver, Colorado, United States, 80221|
|Principal Investigator:||Michael J Bade, PhD, PT||Regis University|