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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

May 15, 2018
June 8, 2018
July 11, 2018
July 2, 2018
May 14, 2019   (Final data collection date for primary outcome measure)
  • 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.
  • 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.
Same as current
Complete list of historical versions of study NCT03550014 on ClinicalTrials.gov Archive Site
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Same as current
Not Provided
Not Provided
 
Effectiveness of Physical Therapy Interventions for Low Back Pain Targeting the Low Back Only or Low Back Plus Hips
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).
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.
Interventional
Not Applicable
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
  • Low Back Pain
  • Hip Disease
  • 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
  • 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
  • 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.
    Intervention: Procedure: Low Back Only
  • 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).
    Intervention: Procedure: Low Back+Hip
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
76
Same as current
May 14, 2020
May 14, 2019   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact: Scott A Burns, DPT 215-204-9016 scott.burns@temple.edu
United States
 
 
NCT03550014
24664
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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
Temple University
Temple University
University of Newcastle, Australia
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
Temple University
July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP