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Completed

NCT Number: NCT02648373

Patient Education for Patients With 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.

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Key information

Conditions

Low Back Pain Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Utah Healthcare System

Salt Lake City, Utah, 84108, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.).

Treatment and study plan

Patient education

Behavioral

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.

Control

Other

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

Primary outcomes

  1. Oswestry Disability Index

    Time frame: 6 weeks

    Self-report measure of low back pain-related disability

  2. Pain as measured by the Numeric Pain Rating Scale

    Time frame: 6 weeks

    Self-report measure of pain intensity on 0-10 rating scale

Secondary outcomes

  1. Fear Avoidance beliefs Questionnaire

    Time frame: baseline, 6 weeks, 3 months

    Self-report measure of fear avoidance beliefs about physical activity and work

  2. Pain Catastrophizing Scale

    Time frame: baseline, 6 weeks, 3 months

    Self-report measure of pain catastrophizing beliefs

  3. 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.

  4. 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

  5. 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

  6. Treatment Self-Regulation Questionnaire

    Time frame: baseline, 6 weeks, 3 months

    Self-report questionnaire examining motivations to attend physical therapy

  7. Hospital Anxiety and Depression Scale

    Time frame: baseline, 6 weeks, 3 months

    Self-report questionnaire assessing anxiety and depression in separate sub-scales

  8. Oswestry Disability Scale

    Time frame: baseline, 3 months

    Self-report measure of low back pain-related disability

  9. Numeric Pain Rating

    Time frame: baseline, 3 months

    Self-report measure of pain intensity on 0-10 scale

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jan 7, 2016
Registry last updated
Jan 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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