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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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ClinicalTrials.gov Identifier: NCT03550014
Recruitment Status : Recruiting
First Posted : June 8, 2018
Last Update Posted : July 11, 2018
Sponsor:
Collaborator:
University of Newcastle, Australia
Information provided by (Responsible Party):
Temple University

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).

Condition or disease Intervention/treatment Phase
Low Back Pain Hip Disease Procedure: Low Back Only Procedure: Low Back+Hip Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
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
Actual Study Start Date : July 2, 2018
Estimated Primary Completion Date : May 14, 2019
Estimated Study Completion Date : May 14, 2020

Resource links provided by the National Library of Medicine


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.
Procedure: Low Back Only
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 Name: standard physical therapy care

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).
Procedure: Low Back+Hip
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 Name: standard physical therapy care




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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 ]
    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.

  2. 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 ]
    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.

  3. 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 ]
    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.

  4. Change from baseline on the Godin Leisure-Time Physical Activity Questionnaire [ Time Frame: Baseline, end of intervention (discharge; an average of 6 weeks) ]
    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.

  5. Patient Health Questionnaire-2 (PHQ-2) [ Time Frame: Baseline ]
    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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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03550014


Contacts
Contact: Scott A Burns, DPT 215-204-9016 scott.burns@temple.edu

Locations
United States, Illinois
OSF St. Francis Medical Center Recruiting
Peoria, Illinois, United States, 61614
Contact: Kate Horst, DPT    309-282-1630    Catherine.m.horst@osfhealthcare.org   
United States, Indiana
Franciscan Health Sports Medicine Physical Therapy Clinic Recruiting
Indianapolis, Indiana, United States, 46237
Contact: Jeevan Pandya, DPT    317-528-5800    jeevan.pandya@franciscanalliance.org   
United States, New Jersey
BSR Physical Therapy Recruiting
Barnegat, New Jersey, United States, 08005
Contact: Steve Ferro, DPT    609-698-1073    sferro@bsrphysicaltherapy.com   
BSR Physical Therapy Recruiting
Manahawkin, New Jersey, United States, 08050
Contact: Ernie Gamble, DPT    609-549-5015    egamble@bsrphysicaltherapy.com   
United States, Pennsylvania
Kinetic Physical Therapy Recruiting
Collegeville, Pennsylvania, United States, 19426
Contact: Jason Elvin, DPT    908-319-6636    jasone@kineticptpa.com   
Temple University Recruiting
Philadelphia, Pennsylvania, United States, 19422
Contact: Scott A Burns, DPT    215-204-9016    scott.burns@temple.edu   
United States, Wisconsin
Bellin Health Systems Recruiting
Green Bay, Wisconsin, United States, 54311
Contact: Joseph Kicksdorf, DPT    920-433-6796    Joseph.Kuscksdorf@belling.org   
Sponsors and Collaborators
Temple University
University of Newcastle, Australia
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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Temple University
ClinicalTrials.gov Identifier: NCT03550014     History of Changes
Other Study ID Numbers: 24664
First Posted: June 8, 2018    Key Record Dates
Last Update Posted: July 11, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: All data will be used as part of research project for dissertation purposes and not shared to other researchers

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Temple University:
Low Back Pain
Hip
Physical Therapy

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms