NCT02648373

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable low-back-pain

Timeline
Completed

Started Oct 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 27, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 7, 2016

Completed
Last Updated

January 7, 2016

Status Verified

January 1, 2016

Enrollment Period

1 year

First QC Date

May 27, 2015

Last Update Submit

January 5, 2016

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (9)

  • Fear Avoidance beliefs Questionnaire

    baseline, 6 weeks, 3 months

  • Pain Catastrophizing Scale

    baseline, 6 weeks, 3 months

  • Pain Beliefs Questionnaire

    baseline, 6 weeks, 3 months

  • Global Rating of Change

    6 weeks, 3 months

  • Physical Therapy Visits: Number of physical therapy episodes attended after baseline

    6 weeks, 3 months

  • +4 more secondary outcomes

Study Arms (2)

Education

EXPERIMENTAL

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

Control

ACTIVE COMPARATOR

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

Other: Control

Interventions

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.

Education
ControlOTHER

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

Control

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Utah Healthcare System

Salt Lake City, Utah, 84108, United States

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Patient Education as Topic

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Health EducationPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D.

Study Record Dates

First Submitted

May 27, 2015

First Posted

January 7, 2016

Study Start

October 1, 2014

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

January 7, 2016

Record last verified: 2016-01

Locations