Clinical Trial: Patient Education for Patients With Back Pain Referred to Physical Therapy

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Effect of a Patient Education Intervention for Patients With Low Back Pain Referred to Physical Therapy

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 Summary: 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.
Sponsor: University of Utah

Current Primary Outcome:

• Oswestry Disability Index [ Time Frame: 6 weeks ]
  Self-report measure of low back pain-related disability
• Pain as measured by the Numeric Pain Rating Scale [ Time Frame: 6 weeks ]
  Self-report measure of pain intensity on 0-10 rating scale

Original Primary Outcome: Same as current

Current Secondary Outcome:

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

Original Secondary Outcome: Same as current

Information By: University of Utah

Dates:
Date Received: May 27, 2015
Date Started: October 2014
Date Completion:
Last Updated: January 5, 2016
Last Verified: January 2016