Patient Education for Patients With Back Pain Referred to Physical Therapy
Effect of a Patient Education Intervention for Patients With Low Back Pain Referred to Physical Therapy
1 other identifier
interventional
76
1 country
1
Brief Summary
The purpose of this study is to evaluate patients with low back pain who are scheduled to begin physical therapy but have not yet had their first appointment to better understand their beliefs and attitudes and to evaluate the effects of an educational session about low back pain.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable low-back-pain
Started Oct 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
May 27, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedFirst Posted
Study publicly available on registry
January 7, 2016
CompletedJanuary 7, 2016
January 1, 2016
1 year
May 27, 2015
January 5, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
Oswestry Disability Index
Self-report measure of low back pain-related disability
6 weeks
Pain as measured by the Numeric Pain Rating Scale
Self-report measure of pain intensity on 0-10 rating scale
6 weeks
Secondary Outcomes (9)
Fear Avoidance beliefs Questionnaire
baseline, 6 weeks, 3 months
Pain Catastrophizing Scale
baseline, 6 weeks, 3 months
Pain Beliefs Questionnaire
baseline, 6 weeks, 3 months
Global Rating of Change
6 weeks, 3 months
Physical Therapy Visits: Number of physical therapy episodes attended after baseline
6 weeks, 3 months
- +4 more secondary outcomes
Study Arms (2)
Education
EXPERIMENTALPatients receive an educational video about low back pain based on the Consumer Reports Choosing Wisely recommendation for patients with back pain to avoid early imaging and remain as active as possible. After the video the evaluator and patient discussed key themes from the video and the patient was able to ask any questions. Previously scheduled physical therapy then began with treatment at the therapist's discretion.
Control
ACTIVE COMPARATORPreviously scheduled physical therapy was provided with treatment at the therapist's discretion. No educational intervention was provided before beginning physical therapy
Interventions
An educational video was watched based on Consumer Reports Choosing Wisely patient education supporting the recommendation that imaging is not helpful early for low back pain and the best strategy is to remain as active as possible. Key themes were discussed with a physical therapist and the patient's questions were answered.
Patients receive no additional intervention. They will begin physical therapy and receive care at the therapist's discretion.
Eligibility Criteria
You may qualify if:
- Chief complaint of non-specific low back pain scheduled to receive outpatient physical therapy
- age 18-60
- duration of current symptoms \< 8weeks
- referred to physical therapy from a non-surgeon provider
- no treatment received for low back pain in past year other than physician office visits.
You may not qualify if:
- Diagnosis provided by the referral source indicating a specific pathoanatomical source for LBP including fracture, spondylolesthesis, ankylosing spondylitis, radiculopathy
- any red flags in the patient's general medical screening questionnaire (i.e. tumor, metabolic diseases etc.).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The University of Utah Healthcare System
Salt Lake City, Utah, 84108, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Ph.D.
Study Record Dates
First Submitted
May 27, 2015
First Posted
January 7, 2016
Study Start
October 1, 2014
Primary Completion
October 1, 2015
Study Completion
October 1, 2015
Last Updated
January 7, 2016
Record last verified: 2016-01