Patient Education for Patients With Back Pain Referred to Physical Therapy

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02648373
• Other study ID #: IRB00072901
• Status: Completed
• Phase: N/A
• First received: May 27, 2015
• Last updated: January 5, 2016
• Start date: October 2014
• Est. completion date: October 2015

Study information

• Verified date: January 2016
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

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.

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

Locations

Country	Name	City	State
United States	The University of Utah Healthcare System	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oswestry Disability Index	Self-report measure of low back pain-related disability	6 weeks	No
Primary	Pain as measured by the Numeric Pain Rating Scale	Self-report measure of pain intensity on 0-10 rating scale	6 weeks	No
Secondary	Fear Avoidance beliefs Questionnaire	Self-report measure of fear avoidance beliefs about physical activity and work	baseline, 6 weeks, 3 months	No
Secondary	Pain Catastrophizing Scale	Self-report measure of pain catastrophizing beliefs	baseline, 6 weeks, 3 months	No
Secondary	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	No
Secondary	Global Rating of Change	Self-report global rating of improvement in condition since baseline assessed on 0-15 scale	6 weeks, 3 months	No
Secondary	Physical Therapy Visits: Number of physical therapy episodes attended after baseline	Number of physical therapy episodes attended after baseline	6 weeks, 3 months	No
Secondary	Treatment Self-Regulation Questionnaire	Self-report questionnaire examining motivations to attend physical therapy	baseline, 6 weeks, 3 months	No
Secondary	Hospital Anxiety and Depression Scale	Self-report questionnaire assessing anxiety and depression in separate sub-scales	baseline, 6 weeks, 3 months	No
Secondary	Oswestry Disability Scale	Self-report measure of low back pain-related disability	baseline, 3 months	No
Secondary	Numeric Pain Rating	Self-report measure of pain intensity on 0-10 scale	baseline, 3 months	No