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NCT Number: NCT02225535

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

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.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Saskatchewan

Saskatoon, Saskatchewan, S7J4W3, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

NP face to face management of Chronic Low Back Pain

Other

usual NP management of chronic low back disorder

PT face to face management of Chronic Low Back Pain

Other

Includes manual therapy, education, exercise

Interprofessional Videoconferencing for Chronic Low Back Pain

Other

Includes manual therapy, education, exercise.

Primary outcomes

  1. Short term impact of patient/provider satisfaction

    Time frame: up to 2 weeks after assessment

    questionnaire

  2. Short term outcome of patient experience with Telehealth

    Time frame: up to 2 weeks

    qualitative questionnaire

  3. Medium term outcome of patient and provider satisfaction

    Time frame: 3 months

    questionnaire

  4. Short term impact of patient function

    Time frame: up to 2 weeks after assessment

    Modified Oswestry Disability questionnaire

  5. Short term impact on pain

    Time frame: up to 2 weeks after assessment

    Numeric Pain Rating Scale - questionnaire

  6. Short term impact on quality of life

    Time frame: up to 2 weeks after assessment

    Euro-Qol health survey instrument (EQ-5D)

  7. Medium term impact on pain

    Time frame: 3 months

    Numeric Pain Rating Scale - questionnaire

  8. Medium term impact on quality of life

    Time frame: 3 months

    Euro-Qol health survey instrument (EQ-5D)

  9. Medium impact on patient function

    Time frame: 3 months

    Modified Oswestry Disability Index questionnaire

Secondary outcomes

  1. Cost effectiveness of each of 3 arms of study

    Time frame: 6 months

    patient diaries

  2. Long term outcome on patient/provider satisfaction

    Time frame: 6 months

    questionnaire

  3. Long term impact on quality of life

    Time frame: 6 months

    Euro-Qol health survey instrument (EQ-5D)

  4. Long term impact on function

    Time frame: 6 months

    Modified Oswestry Disability Index questionnaire

  5. Long term impact on pain

    Time frame: 6 months

    Numeric Pain Rating Scale

Other outcomes

  1. Barriers and facilitators to use of Telehealth

    Time frame: 2 weeks

    questionnaire

Sponsors and collaborators

Lead sponsor

University of Saskatchewan

Other

Collaborators

  • Ralston Brothers Grant (Kelsey Trail Health Region)
  • Saskatchewan Health Research Foundation

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Aug 26, 2014
Registry last updated
Oct 11, 2018

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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