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Patient Education for Patients With Back Pain Referred to Physical Therapy

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Patient Education
Control
Sponsored by
University of Utah
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.).

Sites / Locations

  • The University of Utah Healthcare System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Education

Control

Arm Description

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.

Previously scheduled physical therapy was provided with treatment at the therapist's discretion. No educational intervention was provided before beginning physical therapy

Outcomes

Primary Outcome Measures

Oswestry Disability Index
Self-report measure of low back pain-related disability
Pain as measured by the Numeric Pain Rating Scale
Self-report measure of pain intensity on 0-10 rating scale

Secondary Outcome Measures

Fear Avoidance beliefs Questionnaire
Self-report measure of fear avoidance beliefs about physical activity and work
Pain Catastrophizing Scale
Self-report measure of pain catastrophizing beliefs
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.
Global Rating of Change
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
Number of physical therapy episodes attended after baseline
Treatment Self-Regulation Questionnaire
Self-report questionnaire examining motivations to attend physical therapy
Hospital Anxiety and Depression Scale
Self-report questionnaire assessing anxiety and depression in separate sub-scales
Oswestry Disability Scale
Self-report measure of low back pain-related disability
Numeric Pain Rating
Self-report measure of pain intensity on 0-10 scale

Full Information

First Posted
May 27, 2015
Last Updated
January 5, 2016
Sponsor
University of Utah
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1. Study Identification

Unique Protocol Identification Number
NCT02648373
Brief Title
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

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Education
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Previously scheduled physical therapy was provided with treatment at the therapist's discretion. No educational intervention was provided before beginning physical therapy
Intervention Type
Behavioral
Intervention Name(s)
Patient Education
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
Patients receive no additional intervention. They will begin physical therapy and receive care at the therapist's discretion.
Primary Outcome Measure Information:
Title
Oswestry Disability Index
Description
Self-report measure of low back pain-related disability
Time Frame
6 weeks
Title
Pain as measured by the Numeric Pain Rating Scale
Description
Self-report measure of pain intensity on 0-10 rating scale
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Fear Avoidance beliefs Questionnaire
Description
Self-report measure of fear avoidance beliefs about physical activity and work
Time Frame
baseline, 6 weeks, 3 months
Title
Pain Catastrophizing Scale
Description
Self-report measure of pain catastrophizing beliefs
Time Frame
baseline, 6 weeks, 3 months
Title
Pain Beliefs Questionnaire
Description
Self-report questionnaire used to measure patients' beliefs about the causes and consequences of pain with 2 subscales: organic (i.e, biomedical) and psychological.
Time Frame
baseline, 6 weeks, 3 months
Title
Global Rating of Change
Description
Self-report global rating of improvement in condition since baseline assessed on 0-15 scale
Time Frame
6 weeks, 3 months
Title
Physical Therapy Visits: Number of physical therapy episodes attended after baseline
Description
Number of physical therapy episodes attended after baseline
Time Frame
6 weeks, 3 months
Title
Treatment Self-Regulation Questionnaire
Description
Self-report questionnaire examining motivations to attend physical therapy
Time Frame
baseline, 6 weeks, 3 months
Title
Hospital Anxiety and Depression Scale
Description
Self-report questionnaire assessing anxiety and depression in separate sub-scales
Time Frame
baseline, 6 weeks, 3 months
Title
Oswestry Disability Scale
Description
Self-report measure of low back pain-related disability
Time Frame
baseline, 3 months
Title
Numeric Pain Rating
Description
Self-report measure of pain intensity on 0-10 scale
Time Frame
baseline, 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.).
Facility Information:
Facility Name
The University of Utah Healthcare System
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States

12. IPD Sharing Statement

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Patient Education for Patients With Back Pain Referred to Physical Therapy

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