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

NCT02225535 | Completed

• 1 other identifier: Bio13-241
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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. 1.in-person PT assessment, where the PT travels from an urban center
2. 2.interprofessional Telehealth assessment where the local NP is joined by a PT via Telehealth.

Conditions

Chronic Low Back Pain

Keywords

low back pain; telehealth; videoconferencing; access to physical therapy; interprofessional care; rural health

Outcome Measures

Primary Outcomes (9)

• Short term impact of patient/provider satisfaction

  questionnaire

  up to 2 weeks after assessment

• Short term outcome of patient experience with Telehealth

  qualitative questionnaire

  up to 2 weeks

• Medium term outcome of patient and provider satisfaction

  questionnaire

  3 months

• Short term impact of patient function

  Modified Oswestry Disability questionnaire

  up to 2 weeks after assessment

• Short term impact on pain

  Numeric Pain Rating Scale - questionnaire

  up to 2 weeks after assessment

• Short term impact on quality of life

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

  up to 2 weeks after assessment

• Medium term impact on pain

  Numeric Pain Rating Scale - questionnaire

  3 months

• Medium term impact on quality of life

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

  3 months

• Medium impact on patient function

  Modified Oswestry Disability Index questionnaire

  3 months

Secondary Outcomes (5)

• Cost effectiveness of each of 3 arms of study

  6 months

• Long term outcome on patient/provider satisfaction

  6 months

• Long term impact on quality of life

  6 months

• Long term impact on function

  6 months

• Long term impact on pain

  6 months

Other Outcomes (1)

• Barriers and facilitators to use of Telehealth

  2 weeks

Study Arms (3)

Usual Care (NP)

PLACEBO COMPARATOR

Rural NP with client in-person, usual care

Other: NP face to face management of Chronic Low Back Pain

PT in-person

ACTIVE COMPARATOR

Urban PT travels to rural area to manage patient's back pain in-person.

Other: PT face to face management of Chronic Low Back Pain

PT/NP Telehealth

ACTIVE COMPARATOR

Intervention: Rural NP is joined by PT via Telehealth for interprofessional videoconference with patient

Other: Interprofessional Videoconferencing for Chronic Low Back Pain

Interventions

NP face to face management of Chronic Low Back Pain OTHER

usual NP management of chronic low back disorder

Usual Care (NP)

PT face to face management of Chronic Low Back Pain OTHER

Includes manual therapy, education, exercise

PT in-person

Interprofessional Videoconferencing for Chronic Low Back Pain OTHER

Includes manual therapy, education, exercise.

PT/NP Telehealth

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult 18-80
• low back pain and/or related leg pain affecting function, \>3 months duration

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Saskatchewan: lead
• Saskatchewan Health Research Foundation: collaborator
• Ralston Brothers Grant (Kelsey Trail Health Region): collaborator

Study Sites (1)

University of Saskatchewan

Saskatoon, Saskatchewan, S7J4W3, Canada

Location

Related Publications (2)

• Lovo S, Imeah B, Sari N, O'Connell ME, Milosavljevic S, Angarita-Fonseca A, Bath B. Effectiveness of an interprofessional assessment and management approach for people with chronic low back disorders delivered via virtual care: A randomized controlled trial pilot intervention. Digit Health. 2024 Jun 5;10:20552076241260569. doi: 10.1177/20552076241260569. eCollection 2024 Jan-Dec.

  PMID: 38846367 DERIVED

• Bath B, Lovo Grona S, Milosavljevic S, Sari N, Imeah B, O'Connell ME. Advancing Interprofessional Primary Health Care Services in Rural Settings for People with Chronic Low Back Disorders: Protocol of a Community-Based Randomized Controlled Trial. JMIR Res Protoc. 2016 Nov 9;5(4):e212. doi: 10.2196/resprot.5914.

  PMID: 27829573 DERIVED

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Brenna Bath, PhD

  School of Physical Therapy, University of Saskatchewan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, School of Physical Therapy

Study Record Dates

• First Submitted: July 31, 2014
• First Posted: August 26, 2014
• Study Start: July 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: October 11, 2018

Record last verified: 2018-10

Locations

CA (1)