Back to resultsEffectiveness of Physical Therapy Interventions for Low Back Pain Targeting the Low Back Only or Low Back Plus Hips
Primary Purpose
Low Back Pain, Hip Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Low Back Only
Low Back+Hip
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain focused on measuring Low Back Pain, Hip, Physical Therapy
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:
- 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
Sites / Locations
- OSF St. Francis Medical Center
- Franciscan Health Sports Medicine Physical Therapy Clinic
- BSR Physical Therapy
- BSR Physical Therapy
- Kinetic Physical Therapy
- Temple University
- Bellin Health Systems
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Low Back Only
Low Back+Hip
Arm Description
Participants randomized to the Low Back Only arm will receive physical therapy as directed by the treating physical therapist targeting the lower back.
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).
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT03550014
First Posted
May 15, 2018
Last Updated
March 29, 2021
Sponsor
Temple University
Collaborators
University of Newcastle, Australia
1. Study Identification
Unique Protocol Identification Number
NCT03550014
Brief Title
Effectiveness of Physical Therapy Interventions for Low Back Pain Targeting the Low Back Only or Low Back Plus Hips
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
July 2, 2018 (Actual)
Primary Completion Date
January 14, 2020 (Actual)
Study Completion Date
January 14, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Temple University
Collaborators
University of Newcastle, Australia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Hip Disease
Keywords
Low Back Pain, Hip, Physical Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
76 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low Back Only
Arm Type
Active Comparator
Arm Description
Participants randomized to the Low Back Only arm will receive physical therapy as directed by the treating physical therapist targeting the lower back.
Arm Title
Low Back+Hip
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Procedure
Intervention Name(s)
Low Back Only
Other Intervention Name(s)
standard physical therapy care
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Low Back+Hip
Other Intervention Name(s)
standard physical therapy care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline on the Modified Oswestry Disability Index (ODI)
Description
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
Title
Change from baseline on the Numeric Pain Rating Scale (NPRS)
Description
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 Outcome Measure Information:
Title
Change from baseline on the Fear Avoidance Beliefs Questionnaire (FABQ)
Description
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
Title
Change from baseline on the Global Rating of Change (GROC)
Description
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.
Time Frame
2 weeks, end of intervention (discharge; an average of 6 weeks), 6 month and 12 months
Title
Change from baseline on the Patient Acceptable Symptom State (PASS)
Description
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.
Time Frame
2 weeks, end of intervention (discharge; an average of 6 weeks), 6 month and 12 months
Title
Change from baseline on the Godin Leisure-Time Physical Activity Questionnaire
Description
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.
Time Frame
Baseline, end of intervention (discharge; an average of 6 weeks)
Title
Patient Health Questionnaire-2 (PHQ-2)
Description
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.
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott A Burns, DPT
Organizational Affiliation
Temple University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Suzanne J Snodgrass, PhD
Organizational Affiliation
The University of Newcastle
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Darren A Rivett, PhD
Organizational Affiliation
The University of Newcastle
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Joshua A Cleland, DPT, PhD
Organizational Affiliation
Franklin Pierce University
Official's Role
Study Director
Facility Information:
Facility Name
OSF St. Francis Medical Center
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61614
Country
United States
Facility Name
Franciscan Health Sports Medicine Physical Therapy Clinic
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46237
Country
United States
Facility Name
BSR Physical Therapy
City
Barnegat
State/Province
New Jersey
ZIP/Postal Code
08005
Country
United States
Facility Name
BSR Physical Therapy
City
Manahawkin
State/Province
New Jersey
ZIP/Postal Code
08050
Country
United States
Facility Name
Kinetic Physical Therapy
City
Collegeville
State/Province
Pennsylvania
ZIP/Postal Code
19426
Country
United States
Facility Name
Temple University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19422
Country
United States
Facility Name
Bellin Health Systems
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54311
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
All data will be used as part of research project for dissertation purposes and not shared to other researchers
Citations:
PubMed Identifier
30217693
Citation
Burns SA, Cleland JA, Rivett DA, Snodgrass SJ. Effectiveness of physical therapy interventions for low back pain targeting the low back only or low back plus hips: a randomized controlled trial protocol. Braz J Phys Ther. 2018 Sep-Oct;22(5):424-430. doi: 10.1016/j.bjpt.2018.08.014. Epub 2018 Sep 7.
Results Reference
derived
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Effectiveness of Physical Therapy Interventions for Low Back Pain Targeting the Low Back Only or Low Back Plus Hips
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