The Effect of Physical Therapy Interventions Directed at the Low Back Versus Low Back and Hips for Individuals With a Primary Complaint of Low Back Pain: A Randomized Clinical Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Low Back Pain
- Sponsor
- Temple University
- Enrollment
- 76
- Locations
- 6
- Primary Endpoint
- Change from baseline on the Numeric Pain Rating Scale (NPRS)
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
Low back pain (LBP) is the leading cause of disability worldwide and has substantial impacts on pain and function for an individual. Some individuals with LBP seek physical therapy for their condition. The purpose of the study is to determine whether individuals with LBP have improved pain and disability following physical therapy targeting either the low back only or low back plus hip(s).
Detailed Description
Often, individuals with LBP also have concurrent impairments in strength and/or range of motion of one or both hips. Physical therapists may or may not decide to treat the concurrent hip impairments for an individual with LBP based on their clinical decision making. Currently, it is unknown which approach leads to superior patient outcomes in terms of pain and disability.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Modified Oswestry Disability Index (ODI) ≥ 20%
- •Numeric Pain Rating Scale (NPRS) of ≥ 2 points
- •Primary complaint of low back pain with at least one hip impairment in one or both hips
Exclusion Criteria
- •Contraindications to manual therapy
- •Severe trauma to the lumbar spine or hip(s) in the last 6 weeks
- •'Red flag' symptoms including:
- •Metabolic disease
- •Rheumatoid arthritis or other systemic rheumatologic disorders
- •Acute fracture
- •Bowel/Bladder dysfunction
- •Prolonged history of corticosteroid use
- •Evidence of central nervous system involvement
- •Two or more positive neurologic signs consistent with nerve root compression:
Outcomes
Primary Outcomes
Change from baseline on the Numeric Pain Rating Scale (NPRS)
Time Frame: Baseline, 2 weeks, end of intervention (discharge; an average of 6 weeks), 6 month and 12 months
The NPRS is an 11 point scale (0-10) where the participant is asked to rate their pain intensity at best, worst and average over the last 24 hours. The scale is anchored on the left (score of 0) with the phrase "No Pain" and on the right (score of 10) with the phrase "Worst Imaginable Pain". The NPRS is a valid and reliable assessment of pain severity for individuals with low back pain.
Change from baseline on the Modified Oswestry Disability Index (ODI)
Time Frame: Baseline, 2 weeks, end of intervention (discharge; an average of 6 weeks), 6 month and 12 months
The ODI is a reliable and responsive 10 question condition-specific self-report measure for individuals with LBP. The ODI is scored on a scale from 0% to 100%, higher scores indicating higher levels of disability.
Secondary Outcomes
- Patient Health Questionnaire-2 (PHQ-2)(Baseline)
- Change from baseline on the Fear Avoidance Beliefs Questionnaire (FABQ)(Baseline, 2 weeks, end of intervention (discharge; an average of 6 weeks), 6 month and 12 months)
- Change from baseline on the Global Rating of Change (GROC)(2 weeks, end of intervention (discharge; an average of 6 weeks), 6 month and 12 months)
- Change from baseline on the Patient Acceptable Symptom State (PASS)(2 weeks, end of intervention (discharge; an average of 6 weeks), 6 month and 12 months)
- Change from baseline on the Godin Leisure-Time Physical Activity Questionnaire(Baseline, end of intervention (discharge; an average of 6 weeks))