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

NCT ID: NCT02225535

Last Updated: 2018-10-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2016-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Chronic Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Usual Care (NP)

Rural NP with client in-person, usual care

Group Type PLACEBO_COMPARATOR

NP face to face management of Chronic Low Back Pain

Intervention Type OTHER

usual NP management of chronic low back disorder

PT in-person

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

Group Type ACTIVE_COMPARATOR

PT face to face management of Chronic Low Back Pain

Intervention Type OTHER

Includes manual therapy, education, exercise

PT/NP Telehealth

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

Group Type ACTIVE_COMPARATOR

Interprofessional Videoconferencing for Chronic Low Back Pain

Intervention Type OTHER

Includes manual therapy, education, exercise.

Interventions

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NP face to face management of Chronic Low Back Pain

usual NP management of chronic low back disorder

Intervention Type OTHER

PT face to face management of Chronic Low Back Pain

Includes manual therapy, education, exercise

Intervention Type OTHER

Interprofessional Videoconferencing for Chronic Low Back Pain

Includes manual therapy, education, exercise.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Saskatchewan Health Research Foundation

OTHER

Sponsor Role collaborator

Ralston Brothers Grant (Kelsey Trail Health Region)

UNKNOWN

Sponsor Role collaborator

University of Saskatchewan

OTHER

Sponsor Role lead

Responsible Party

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Brenna Bath

Assistant Professor, School of Physical Therapy

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Brenna Bath, PhD

Role: PRINCIPAL_INVESTIGATOR

School of Physical Therapy, University of Saskatchewan

Locations

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University of Saskatchewan

Saskatoon, Saskatchewan, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED
PMID: 38846367 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27829573 (View on PubMed)

Other Identifiers

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Bio13-241

Identifier Type: -

Identifier Source: org_study_id

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