Investigation of a Physiotherapist and Nurse Practitioner Intervention for Chronic Low Back Disorders Delivered Through Telehealth

Chronic Low Back Pain Clinical Trial

Official title:

Advancing Interprofessional Primary Health Care Services in Rural Settings for People With Chronic Low Back Disorders: Investigation of a Physiotherapist and Nurse Practitioner Intervention Delivered Through Telehealth

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02225535
• Other study ID #: Bio13-241
• Status: Completed
• Phase: N/A
• Start date: July 2014
• Est. completion date: January 2016

Study information

• Verified date: October 2018
• Source: University of Saskatchewan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this project is to compare "usual care" for chronic low back disorders in a rural setting (nurse practitioner/NP) to two different means of integrating Physical Therapy (PT) into a rural health care team:

1. in-person PT assessment, where the PT travels from an urban center

2. interprofessional Telehealth assessment where the local NP is joined by a PT via Telehealth.

The project will evaluate health, systems and process outcomes, comparative effectiveness and costs of the three methods of assessment. The hypothesis is that an interprofessional Telehealth assessment with be as effective as an in-person PT assessment, but more effective than usual care.

Description:

The study design will include two intervention groups and a control group with 20 participants in each group: 1. interprofessional videoconferencing intervention, 2. in-person PT and, 3. "usual-care" provided by a NP. Due to the interprofessional nature of the intervention, the NP involved in the telehealth-based intervention group may alter their "usual care" practice; therefore, the control group participants will be drawn from the practices of 2 NPs not involved in the Telehealth intervention providing services out of a different clinic. Each PT and the NP alone will complete a standardized online diagnostic classification tool.Participants will be randomly assigned to one of the three groups.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• adult 18-80

• low back pain and/or related leg pain affecting function, >3 months duration

Exclusion Criteria:

• clients within a third party payer insurance coverage system

• clients with primarily neck or thoracic pain

• clients with language or comprehension difficulties that would limit completion of paperwork

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Low Back Pain

Intervention

Other:
• NP face to face management of Chronic Low Back Pain
usual NP management of chronic low back disorder
• PT face to face management of Chronic Low Back Pain
Includes manual therapy, education, exercise
• Interprofessional Videoconferencing for Chronic Low Back Pain
Includes manual therapy, education, exercise.

Locations

Country	Name	City	State
Canada	University of Saskatchewan	Saskatoon	Saskatchewan

Sponsors (3)

Lead Sponsor	Collaborator
University of Saskatchewan	Ralston Brothers Grant (Kelsey Trail Health Region), Saskatchewan Health Research Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Barriers and facilitators to use of Telehealth	questionnaire	2 weeks
Primary	Short term impact of patient/provider satisfaction	questionnaire	up to 2 weeks after assessment
Primary	Short term outcome of patient experience with Telehealth	qualitative questionnaire	up to 2 weeks
Primary	Medium term outcome of patient and provider satisfaction	questionnaire	3 months
Primary	Short term impact of patient function	Modified Oswestry Disability questionnaire	up to 2 weeks after assessment
Primary	Short term impact on pain	Numeric Pain Rating Scale - questionnaire	up to 2 weeks after assessment
Primary	Short term impact on quality of life	Euro-Qol health survey instrument (EQ-5D)	up to 2 weeks after assessment
Primary	Medium term impact on pain	Numeric Pain Rating Scale - questionnaire	3 months
Primary	Medium term impact on quality of life	Euro-Qol health survey instrument (EQ-5D)	3 months
Primary	Medium impact on patient function	Modified Oswestry Disability Index questionnaire	3 months
Secondary	Cost effectiveness of each of 3 arms of study	patient diaries	6 months
Secondary	Long term outcome on patient/provider satisfaction	questionnaire	6 months
Secondary	Long term impact on quality of life	Euro-Qol health survey instrument (EQ-5D)	6 months
Secondary	Long term impact on function	Modified Oswestry Disability Index questionnaire	6 months
Secondary	Long term impact on pain	Numeric Pain Rating Scale	6 months