Effectiveness of Physical Therapy Interventions for Low Back Pain Targeting the Low Back Only or Low Back Plus Hips

Temple University76 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Low Back Pain Hip Disease

Interventions

Low Back OnlyPROCEDURE

The physical therapy interventions are commonly performed in and may include stretching, strengthening, hands-on techniques, etc. The interventions will only be directed at the lower back. Standard plan of care delivered to participants with low back pain and concurrent hip impairments within scope of licensure.

Low Back+HipPROCEDURE

The physical therapy interventions are commonly performed in and may include stretching, strengthening, hands-on techniques, etc. The interventions will be directed at the lower back and the hips. Standard plan of care delivered to participants with low back pain and concurrent hip impairments within scope of licensure.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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: * Tumor * 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: * Diminished muscle stretch reflexes of lower extremity * Muscle weakness in any lower extremity myotome * Diminished or absent sensation in any lower extremity dermatome * Spinal surgery in the last 6 months * Total Hip Arthroplasty * Currently pregnant or post-partum ≤ 6 months * Osteoporosis * History of cancer within the last 12 months * Inability to understand the English language

Locations (7)

OSF St. Francis Medical Center

Peoria, Illinois, United States

Franciscan Health Sports Medicine Physical Therapy Clinic

Indianapolis, Indiana, United States

BSR Physical Therapy

Barnegat, New Jersey, United States

BSR Physical Therapy

Manahawkin, New Jersey, United States

Outcomes

Primary Outcomes

Change from baseline on the Modified Oswestry Disability Index (ODI)

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.

Time frame: Baseline, 2 weeks, end of intervention (discharge; an average of 6 weeks), 6 month and 12 months

Change from baseline on the Numeric Pain Rating Scale (NPRS)

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.

Time frame: Baseline, 2 weeks, end of intervention (discharge; an average of 6 weeks), 6 month and 12 months

Secondary Outcomes

Change from baseline on the Fear Avoidance Beliefs Questionnaire (FABQ)

The FABQ is a 16-item questionnaire designed to quantify fear and avoidance beliefs in patients with LBP. The FABQ has two sub-scales, a 7-item scale to measure fear-avoidance beliefs about work-related activities (FABQ-W) and a 4-item scale to measure fear-avoidance beliefs about physical activity (FABQ-PA). Each item is scored from 0-6 with possible scores ranging between 0-24 and 0-42 for the physical activity and work subscales, respectively, with higher scores representing increased fear-avoidance beliefs. Recent evidence suggests that the FABQ may be a valuable piece of data for predicting outcomes following intervention in work-related low back pain patients.

Time frame: 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)

The GROC is a 15-point scale that ranges from -7 (a very great deal worse) to zero (about the same) to +7 (a very great deal better). 28 Descriptors of worsening or improving are assigned values from -1 to -6 and +1 to +6 respectively. It has been reported that scores of +4 and +5 are indicative of moderate changes in patient status and scores of +6 and +7 indicate large changes in patient status. This scale will not be administered at baseline evaluation, but at all subsequent time points.

Data from ClinicalTrials.gov

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