Clinical trial NCT02648373: Patient Education for Patients With Back Pain Referred to Physical Therapy
Official title: Effect of a Patient Education Intervention for Patients With Low Back Pain Referred to Physical Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2016-01-07
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.).

Primary outcomes:
measure: Oswestry Disability Index
timeFrame: 6 weeks
measure: Pain as measured by the Numeric Pain Rating Scale
timeFrame: 6 weeks
Secondary outcomes:
measure: Fear Avoidance beliefs Questionnaire
timeFrame: baseline, 6 weeks, 3 months
measure: Pain Catastrophizing Scale
timeFrame: baseline, 6 weeks, 3 months
measure: Pain Beliefs Questionnaire
timeFrame: baseline, 6 weeks, 3 months
measure: Global Rating of Change
timeFrame: 6 weeks, 3 months
measure: Physical Therapy Visits: Number of physical therapy episodes attended after baseline
timeFrame: 6 weeks, 3 months
measure: Treatment Self-Regulation Questionnaire
timeFrame: baseline, 6 weeks, 3 months
measure: Hospital Anxiety and Depression Scale
timeFrame: baseline, 6 weeks, 3 months
measure: Oswestry Disability Scale
timeFrame: baseline, 3 months
measure: Numeric Pain Rating
timeFrame: baseline, 3 months
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: The University of Utah Healthcare System
state: Utah
Study officials:
References: