Chronic Low Back PainNCT02225535
Investigation of a Physiotherapist and Nurse Practitioner Intervention for Chronic Low Back Disorders Delivered Through Telehealth
A study testing NP face to face management of Chronic Low Back Pain, PT face to face management of Chronic Low Back Pain and Interprofessional Videoconferencing for Chronic Low Back Pain in people with Chronic Low Back Pain, run by University of Saskatchewan at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- NP face to face management of Chronic Low Back Pain, PT face to face management of Chronic Low Back Pain and Interprofessional Videoconferencing for Chronic Low Back Pain
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2014to Jan 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult 18-80
- low back pain and/or related leg pain affecting function, >3 months duration
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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:
- in-person PT assessment, where the PT travels from an urban center
- 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.
Read the detailed 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.
- Conditions
- Chronic Low Back Pain
- Being tested
- NP face to face management of Chronic Low Back Pain, PT face to face management of Chronic Low Back Pain, Interprofessional Videoconferencing for Chronic Low Back Pain
- Keywords
- low back pain, telehealth, videoconferencing, access to physical therapy, interprofessional care, rural health
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NP face to face management of Chronic Low Back PainOther
usual NP management of chronic low back disorder
PT face to face management of Chronic Low Back PainOther
Includes manual therapy, education, exercise
Interprofessional Videoconferencing for Chronic Low Back PainOther
Includes manual therapy, education, exercise.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care (NP) | Placebo comparator | Rural NP with client in-person, usual care Receives: 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. Receives: 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 Receives: Other: Interprofessional Videoconferencing for Chronic Low Back Pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short term impact of patient/provider satisfaction
questionnaire
Measured: up to 2 weeks after assessment
Short term outcome of patient experience with Telehealth
qualitative questionnaire
Measured: up to 2 weeks
Medium term outcome of patient and provider satisfaction
questionnaire
Measured: 3 months
Short term impact of patient function
Modified Oswestry Disability questionnaire
Measured: up to 2 weeks after assessment
Short term impact on pain
Numeric Pain Rating Scale - questionnaire
Measured: up to 2 weeks after assessment
Short term impact on quality of life
Euro-Qol health survey instrument (EQ-5D)
Measured: up to 2 weeks after assessment
Medium term impact on pain
Numeric Pain Rating Scale - questionnaire
Measured: 3 months
Medium term impact on quality of life
Euro-Qol health survey instrument (EQ-5D)
Measured: 3 months
Medium impact on patient function
Modified Oswestry Disability Index questionnaire
Measured: 3 months
Secondary outcomes (5)
Cost effectiveness of each of 3 arms of study
patient diaries
Measured: 6 months
Long term outcome on patient/provider satisfaction
questionnaire
Measured: 6 months
Long term impact on quality of life
Euro-Qol health survey instrument (EQ-5D)
Measured: 6 months
Long term impact on function
Modified Oswestry Disability Index questionnaire
Measured: 6 months
Long term impact on pain
Numeric Pain Rating Scale
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2014 (estimated)
- Study startJul 2014
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Collaborators
- Saskatchewan Health Research Foundation, Ralston Brothers Grant (Kelsey Trail Health Region)
- Responsible party
- Principal investigator, Brenna Bath, University of Saskatchewan
- Investigators
- Brenna Bath, PhD, Principal investigator, School of Physical Therapy, University of Saskatchewan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02225535
- Sponsor's protocol ID
- Bio13-241
- Status last verified
- Oct 2018
- First submitted
- 31 Jul 2014
- Last updated
- 11 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 38846367Bath 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.
PubMed 27829573
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02225535
- Acronym / sponsor ID
- Bio13-241
- Conditions
- Chronic Low Back Pain
- Keywords
- low back pain, telehealth, videoconferencing, access to physical therapy, interprofessional care, rural health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Collaborators
- Saskatchewan Health Research Foundation, Ralston Brothers Grant (Kelsey Trail Health Region)
- Study start
- Jul 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 26 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- in-person PT assessment, where the PT travels from an urban center
- 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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Usual Care (NP) | Placebo comparator | Other: NP face to face management of Chronic Low Back PainRural NP with client in-person, usual care |
| PT in-person | Active comparator | Other: PT face to face management of Chronic Low Back PainUrban PT travels to rural area to manage patient's back pain in-person. |
| PT/NP Telehealth | Active comparator | Other: Interprofessional Videoconferencing for Chronic Low Back PainIntervention: Rural NP is joined by PT via Telehealth for interprofessional videoconference with patient |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- adult 18-80
- low back pain and/or related leg pain affecting function, >3 months duration
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NP face to face management of Chronic Low Back Painusual NP management of chronic low back disorder | Other | Usual Care (NP) |
| PT face to face management of Chronic Low Back PainIncludes manual therapy, education, exercise | Other | PT in-person |
| Interprofessional Videoconferencing for Chronic Low Back PainIncludes manual therapy, education, exercise. | Other | PT/NP Telehealth |
Primary outcome
Short term impact of patient/provider satisfaction
Time frame: up to 2 weeks after assessment
questionnaire
Short term outcome of patient experience with Telehealth
Time frame: up to 2 weeks
qualitative questionnaire
Medium term outcome of patient and provider satisfaction
Time frame: 3 months
questionnaire
Short term impact of patient function
Time frame: up to 2 weeks after assessment
Modified Oswestry Disability questionnaire
Short term impact on pain
Time frame: up to 2 weeks after assessment
Numeric Pain Rating Scale - questionnaire
Short term impact on quality of life
Time frame: up to 2 weeks after assessment
Euro-Qol health survey instrument (EQ-5D)
Medium term impact on pain
Time frame: 3 months
Numeric Pain Rating Scale - questionnaire
Medium term impact on quality of life
Time frame: 3 months
Euro-Qol health survey instrument (EQ-5D)
Medium impact on patient function
Time frame: 3 months
Modified Oswestry Disability Index questionnaire
5 secondary outcomes
Cost effectiveness of each of 3 arms of study
Time frame: 6 months
Long term outcome on patient/provider satisfaction
Time frame: 6 months
Long term impact on quality of life
Time frame: 6 months
Long term impact on function
Time frame: 6 months
Long term impact on pain
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2018.
- Derived from this study: PubMed 38846367Lovo 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.
- Derived from this study: PubMed 27829573Bath 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brenna Bath, PhD principal investigator
School of Physical Therapy, University of Saskatchewan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NP face to face management of Chronic Low Back Pain, PT face to face management of Chronic Low Back Pain and Interprofessional Videoconferencing for Chronic Low Back Pain in people with Chronic Low Back Pain, run by University of Saskatchewan at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short term impact of patient/provider satisfaction (time frame: up to 2 weeks after assessment). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02225535, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2018.