Effectiveness of Physical Therapy Interventions for Low Back Pain Targeting the Low Back Only or Low Back Plus Hips
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03550014|
Recruitment Status : Recruiting
First Posted : June 8, 2018
Last Update Posted : July 11, 2018
|Condition or disease||Intervention/treatment||Phase|
|Low Back Pain Hip Disease||Procedure: Low Back Only Procedure: Low Back+Hip||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||76 participants|
|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)|
|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|
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
- 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.
- 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.
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
|Contact: Scott A Burns, DPTfirstname.lastname@example.org|
|United States, Illinois|
|OSF St. Francis Medical Center||Recruiting|
|Peoria, Illinois, United States, 61614|
|Contact: Kate Horst, DPT 309-282-1630 Catherine.email@example.com|
|United States, Indiana|
|Franciscan Health Sports Medicine Physical Therapy Clinic||Recruiting|
|Indianapolis, Indiana, United States, 46237|
|Contact: Jeevan Pandya, DPT 317-528-5800 firstname.lastname@example.org|
|United States, New Jersey|
|BSR Physical Therapy||Recruiting|
|Barnegat, New Jersey, United States, 08005|
|Contact: Steve Ferro, DPT 609-698-1073 email@example.com|
|BSR Physical Therapy||Recruiting|
|Manahawkin, New Jersey, United States, 08050|
|Contact: Ernie Gamble, DPT 609-549-5015 firstname.lastname@example.org|
|United States, Pennsylvania|
|Kinetic Physical Therapy||Recruiting|
|Collegeville, Pennsylvania, United States, 19426|
|Contact: Jason Elvin, DPT 908-319-6636 email@example.com|
|Philadelphia, Pennsylvania, United States, 19422|
|Contact: Scott A Burns, DPT 215-204-9016 firstname.lastname@example.org|
|United States, Wisconsin|
|Bellin Health Systems||Recruiting|
|Green Bay, Wisconsin, United States, 54311|
|Contact: Joseph Kicksdorf, DPT 920-433-6796 Joseph.Kuscksdorf@belling.org|
|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|