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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02648373
Enrollment
76
Registered
2016-01-07
Start date
2014-10-31
Completion date
2015-10-31
Last updated
2016-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Back Pain

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.

Interventions

BEHAVIORALPatient Education

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.

OTHERControl

Patients receive no additional intervention. They will begin physical therapy and receive care at the therapist's discretion.

Sponsors

University of Utah
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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.).

Design outcomes

Primary

MeasureTime frameDescription
Oswestry Disability Index6 weeksSelf-report measure of low back pain-related disability
Pain as measured by the Numeric Pain Rating Scale6 weeksSelf-report measure of pain intensity on 0-10 rating scale

Secondary

MeasureTime frameDescription
Pain Catastrophizing Scalebaseline, 6 weeks, 3 monthsSelf-report measure of pain catastrophizing beliefs
Pain Beliefs Questionnairebaseline, 6 weeks, 3 monthsSelf-report questionnaire used to measure patients' beliefs about the causes and consequences of pain with 2 subscales: organic (i.e, biomedical) and psychological.
Physical Therapy Visits: Number of physical therapy episodes attended after baseline6 weeks, 3 monthsNumber of physical therapy episodes attended after baseline
Global Rating of Change6 weeks, 3 monthsSelf-report global rating of improvement in condition since baseline assessed on 0-15 scale
Hospital Anxiety and Depression Scalebaseline, 6 weeks, 3 monthsSelf-report questionnaire assessing anxiety and depression in separate sub-scales
Oswestry Disability Scalebaseline, 3 monthsSelf-report measure of low back pain-related disability
Numeric Pain Ratingbaseline, 3 monthsSelf-report measure of pain intensity on 0-10 scale
Treatment Self-Regulation Questionnairebaseline, 6 weeks, 3 monthsSelf-report questionnaire examining motivations to attend physical therapy
Fear Avoidance beliefs Questionnairebaseline, 6 weeks, 3 monthsSelf-report measure of fear avoidance beliefs about physical activity and work

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026