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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Low Back Pain, Hip Disease

Intervention / Treatment
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* Procedure: Low Back Only
* Procedure: Low Back+Hip


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomized to have receive physical therapy targeting the low back only or low back plus hip(s). Neither the participants or investigators can be blinded during this trial.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Low Back Only<br>Participants randomized to the Low Back Only arm will receive physical therapy as directed by the treating physical therapist targeting the lower back. | Procedure: Low Back Only<br>* 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.<br>* Other names: standard physical therapy care;|
| Active Comparator: Low Back+Hip<br>Participants randomized to the Low Back+Hip arm will receive physical therapy as directed by the treating physical therapist targeting the lower back. In addition to that treatment, participants will received hands-on and exercise physical therapy interventions directed at the hip(s). | Procedure: Low Back+Hip<br>* 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.<br>* Other names: standard physical therapy care;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Baseline, 2 weeks, end of intervention (discharge; an average of 6 weeks), 6 month and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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) | The PASS is a single question designed to determine if an individual considers their current status as 'feeling well'. The PASS question was: Taking into account all the activities you have during your daily life, your level of pain, and also your functional impairment, do you consider that your current state is satisfactory? The participant response with a 'yes' or 'no' answer. | 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 | The Godin-Shepard Leisure-Time Physical Activity Questionnaire allows for self-reported leisure-time physical activity. It allows the participant to designate the number of times per week that the engage in physical activities that are of varying intensities (strenuous, moderate, mild). The sum of each intensity is then multiplied by their corresponding metabolic equivalent values of 9, 5, and 3, respectively. High total scores provide the frequency and intensity of exercise that an individual participates in on a weekly basis. The questionnaire has been validated for classifying healthy adults into active and insufficiently active categories. A lack of physical activity in leisure times have been associated with increased prevalence of low back pain. | Baseline, end of intervention (discharge; an average of 6 weeks) | 
| Patient Health Questionnaire-2 (PHQ-2) | The PHQ-2 is a validated two-question screening questionnaire that is used to determine the presence of depressive disorders. Individuals with low back pain that have depressive symptoms tend to have poor outcomes. The two questions are completed by the participant and scored on a 0-3 scale. The scores for both questions are summed with a cut off score of 3 or higher is considered more at risk for the presence of any depressive disorder. | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hip, Low Back Pain, Physical Therapy