- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03550014
Effectiveness of Physical Therapy Interventions for Low Back Pain Targeting the Low Back Only or Low Back Plus Hips
March 29, 2021 updated by: Temple University
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
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
76
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Illinois
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Peoria, Illinois, United States, 61614
- OSF St. Francis Medical Center
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Indiana
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Indianapolis, Indiana, United States, 46237
- Franciscan Health Sports Medicine Physical Therapy Clinic
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New Jersey
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Barnegat, New Jersey, United States, 08005
- BSR Physical Therapy
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Manahawkin, New Jersey, United States, 08050
- BSR Physical Therapy
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Pennsylvania
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Collegeville, Pennsylvania, United States, 19426
- Kinetic Physical Therapy
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Philadelphia, Pennsylvania, United States, 19422
- Temple University
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Wisconsin
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Green Bay, Wisconsin, United States, 54311
- Bellin Health Systems
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Low Back Only
Participants randomized to the Low Back Only arm will receive physical therapy as directed by the treating physical therapist targeting the lower back.
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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.
Other Names:
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Active Comparator: Low Back+Hip
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).
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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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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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.
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Baseline, 2 weeks, end of intervention (discharge; an average of 6 weeks), 6 month and 12 months
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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
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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.
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Baseline, 2 weeks, end of intervention (discharge; an average of 6 weeks), 6 month and 12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline on the Fear Avoidance Beliefs Questionnaire (FABQ)
Time Frame: Baseline, 2 weeks, end of intervention (discharge; an average of 6 weeks), 6 month and 12 months
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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.
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Baseline, 2 weeks, end of intervention (discharge; an average of 6 weeks), 6 month and 12 months
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Change from baseline on the Global Rating of Change (GROC)
Time Frame: 2 weeks, end of intervention (discharge; an average of 6 weeks), 6 month and 12 months
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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.
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2 weeks, end of intervention (discharge; an average of 6 weeks), 6 month and 12 months
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Change from baseline on the Patient Acceptable Symptom State (PASS)
Time Frame: 2 weeks, end of intervention (discharge; an average of 6 weeks), 6 month and 12 months
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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.
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2 weeks, end of intervention (discharge; an average of 6 weeks), 6 month and 12 months
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Change from baseline on the Godin Leisure-Time Physical Activity Questionnaire
Time Frame: Baseline, end of intervention (discharge; an average of 6 weeks)
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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.
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Baseline, end of intervention (discharge; an average of 6 weeks)
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Patient Health Questionnaire-2 (PHQ-2)
Time Frame: Baseline
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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.
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Baseline
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Scott A Burns, DPT, Temple University
- Study Chair: Suzanne J Snodgrass, PhD, The University of Newcastle
- Study Director: Darren A Rivett, PhD, The University of Newcastle
- Study Director: Joshua A Cleland, DPT, PhD, Franklin Pierce University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 2, 2018
Primary Completion (Actual)
January 14, 2020
Study Completion (Actual)
January 14, 2021
Study Registration Dates
First Submitted
May 15, 2018
First Submitted That Met QC Criteria
May 25, 2018
First Posted (Actual)
June 8, 2018
Study Record Updates
Last Update Posted (Actual)
April 1, 2021
Last Update Submitted That Met QC Criteria
March 29, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 24664
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
All data will be used as part of research project for dissertation purposes and not shared to other researchers
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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