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

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.

Study Overview

• Status: Completed
• Conditions: Low Back Pain
• Intervention / Treatment: Behavioral: Patient Education; Other: Control

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.

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84108
      • The University of Utah Healthcare System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Education; 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; 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.
Active Comparator: Control; Previously scheduled physical therapy was provided with treatment at the therapist's discretion. No educational intervention was provided before beginning physical therapy	Other: Control; Patients receive no additional intervention. They will begin physical therapy and receive care at the therapist's discretion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fear Avoidance beliefs Questionnaire	Self-report measure of fear avoidance beliefs about physical activity and work	baseline, 6 weeks, 3 months
Pain Catastrophizing Scale	Self-report measure of pain catastrophizing beliefs	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.	baseline, 6 weeks, 3 months
Global Rating of Change	Self-report global rating of improvement in condition since baseline assessed on 0-15 scale	6 weeks, 3 months
Physical Therapy Visits: Number of physical therapy episodes attended after baseline	Number of physical therapy episodes attended after baseline	6 weeks, 3 months
Treatment Self-Regulation Questionnaire	Self-report questionnaire examining motivations to attend physical therapy	baseline, 6 weeks, 3 months
Hospital Anxiety and Depression Scale	Self-report questionnaire assessing anxiety and depression in separate sub-scales	baseline, 6 weeks, 3 months
Oswestry Disability Scale	Self-report measure of low back pain-related disability	baseline, 3 months
Numeric Pain Rating	Self-report measure of pain intensity on 0-10 scale	baseline, 3 months

Collaborators and Investigators

• Sponsor: University of Utah

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: May 27, 2015
• First Submitted That Met QC Criteria: January 5, 2016
• First Posted (Estimate): January 7, 2016

Study Record Updates

• Last Update Posted (Estimate): January 7, 2016
• Last Update Submitted That Met QC Criteria: January 5, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: IRB00072901