An interventional study of Patient Education and Control in Low Back Pain, sponsored by University of Utah. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2016-01-07.
Sponsored by University of Utah · Not applicable, Interventional, and Treatment
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.
The investigators will conduct a randomized trial to examine the effectiveness of a patient education session provided prior to beginning physical therapy on outcomes of usual physical therapy for acute/sub-acute low back pain patients. The study compares two groups, one group will be treated with usual physical therapy with no pre-treatment education and the other group will also receive the pre-treatment. Patients will be followed after 6 weeks and 3 months. Physical therapy care is left to the discretion of the physical therapist in conjunction with the patient. Outcomes will include pain and disability, and patients attitude and believes (pain catastrophizing, fear avoidance behavior). The overall hypothesis is that the additional educational treatment may address and improve pain, disability and fear.
2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.
This study's enrollment of 76 is above the median of 60 across 1,941 interventional studies indexed under Back Pain.
Browse Back Pain studies →University of Utah is the lead sponsor of 969 studies on the registry; 178 are open to participants now.
Of its 107 completed or terminated interventional studies of FDA-regulated products, 62 (58%) have results posted.
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Exclusion Criteria:
Patients 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.
Behavioral: Patient Education
Previously scheduled physical therapy was provided with treatment at the therapist's discretion. No educational intervention was provided before beginning physical therapy
Other: Control
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.
Oswestry Disability Index
Self-report measure of low back pain-related disability
Time frame: 6 weeks
Pain as measured by the Numeric Pain Rating Scale
Self-report measure of pain intensity on 0-10 rating scale
Time frame: 6 weeks
Fear Avoidance beliefs Questionnaire
Self-report measure of fear avoidance beliefs about physical activity and work
Time frame: baseline, 6 weeks, 3 months
Pain Catastrophizing Scale
Self-report measure of pain catastrophizing beliefs
Time frame: baseline, 6 weeks, 3 months
Pain Beliefs Questionnaire
Self-report questionnaire used to measure patients' beliefs about the causes and consequences of pain with 2 subscales: organic (i.e, biomedical) and psychological.
Time frame: baseline, 6 weeks, 3 months
Global Rating of Change
Self-report global rating of improvement in condition since baseline assessed on 0-15 scale
Time frame: 6 weeks, 3 months
Physical Therapy Visits: Number of physical therapy episodes attended after baseline
Number of physical therapy episodes attended after baseline
Time frame: 6 weeks, 3 months
Treatment Self-Regulation Questionnaire
Self-report questionnaire examining motivations to attend physical therapy
Time frame: baseline, 6 weeks, 3 months
Hospital Anxiety and Depression Scale
Self-report questionnaire assessing anxiety and depression in separate sub-scales
Time frame: baseline, 6 weeks, 3 months
Oswestry Disability Scale
Self-report measure of low back pain-related disability
Time frame: baseline, 3 months
Numeric Pain Rating
Self-report measure of pain intensity on 0-10 scale
Time frame: baseline, 3 months
This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.
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University of Utah