Back Pain Lower Back ChronicNCT02960269
Interprofessional Management of Chronic Back Pain in Rural and Remote Setting: Use of Telehealth vs. Secure Laptop-based Videoconferencing
A study testing interprofessional back pain assessment in people with Back Pain Lower Back Chronic, run by University of Saskatchewan at 1 site in Canada.
Trial summary
This pilot study will evaluate the impact and overall experience of an interprofessional chronic low back pain patient care approach for people in rural and remote areas using Telehealth technology compared to secure laptop based videoconferencing (Vidyo). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Back Pain Lower Back Chronic
- What is being tested?
- interprofessional back pain assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2016to Dec 2017
- 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
- chronic low back pain localized below costal margins and above gluteal folds and/or related leg pain, which is bad enough to limit their usual activities or daily routine and has been present for at least 3 months
Who cannot join
- People with: third party payer insurance (i.e.worker's compensation board) for their back related complaints, with primarily neck or thoracic pain, and/ or with language, reading or comprehension barriers that would limit their ability to adequately complete the required study paperwork will be excluded from participating in the study.
Trial locations and contacts
1 site in 1 country.
About this study
This pilot study will evaluate the impact and overall experience of an interprofessional chronic low back pain patient care approach for people in rural and remote areas using Telehealth technology compared to secure laptop based videoconferencing (Vidyo).
Read the detailed description
People with chronic low back pain will be recruited to participate in a team assessment with a local rural nurse practitioner and an-urban based physiotherapist linking through telehealth. The assessment will include a detailed history, physical examination and jointly-delivered education and recommendations for further community-based management. Pre and post measures of self-reported pain, back-specific function, quality of life, and satisfaction will be completed 2-4 weeks after the assessment. Comparison of short-term outcomes will be made with a group of participants from another study using the a different telehealth technology (secure laptop based videoconferencing) same inclusion criteria, measures and health care providers (Clin Trials.gov NCT02225535). The health care providers will be interviewed to get feedback on their preference and experience using the different type of telehealth technology.
- Conditions
- Back Pain Lower Back Chronic
- Being tested
- interprofessional back pain assessment
- Keywords
- rural health, telehealth, physiotherapy, interprofessional
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interprofessional back pain assessmentOther
team assessment and education with urban physical therapist and rural nurse practitioner via telehealth
| Study group | Role | What they receive |
|---|---|---|
| Telehealth team assessment | Experimental | Team assessment for back pain with nurse practitioner and physical therapist via telehealth Receives: Other: interprofessional back pain assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient experience with telehealth
Measured: 2-4 weeks after assessment
Pain
Numeric Pain Rating Scale
Measured: 2-4 weeks after assessment
Back-specific function
Modified Oswestry Disability Index
Measured: 2-4 weeks after assessment
Participant satisfaction
Modified VSQ-9
Measured: 2-4 weeks after assessment
Secondary outcomes (1)
Health care provider experience
experience with telehealth technology
Measured: within 2 weeks of completion of all assessments
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionMar 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Back Pain Lower Back ChronicStudies 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Collaborators
- Kelsey Trail Health Region
- Responsible party
- Principal investigator, Brenna Bath, University of Saskatchewan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02960269
- Sponsor's protocol ID
- Bio16-49
- Status last verified
- Oct 2018
- First submitted
- 7 Nov 2016
- Last updated
- 11 Oct 2018
- Results posted
- No
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
- Interprofessional Management of Chronic Back Pain in Rural and Remote Setting: Use of Telehealth vs. Secure Laptop-based Videoconferencing
- ClinicalTrials.gov ID
- NCT02960269
- Acronym / sponsor ID
- Bio16-49
- Conditions
- Back Pain Lower Back Chronic
- Keywords
- rural health, telehealth, physiotherapy, interprofessional
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Collaborators
- Kelsey Trail Health Region
- Study start
- Nov 2016
- Primary completion
- Mar 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 9 Nov 2016 (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.
This pilot study will evaluate the impact and overall experience of an interprofessional chronic low back pain patient care approach for people in rural and remote areas using Telehealth technology compared to secure laptop based videoconferencing (Vidyo).
Detailed description
People with chronic low back pain will be recruited to participate in a team assessment with a local rural nurse practitioner and an-urban based physiotherapist linking through telehealth. The assessment will include a detailed history, physical examination and jointly-delivered education and recommendations for further community-based management. Pre and post measures of self-reported pain, back-specific function, quality of life, and satisfaction will be completed 2-4 weeks after the assessment. Comparison of short-term outcomes will be made with a group of participants from another study using the a different telehealth technology (secure laptop based videoconferencing) same inclusion criteria, measures and health care providers (Clin Trials.gov NCT02225535). The health care providers will be interviewed to get feedback on their preference and experience using the different type of telehealth technology.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Telehealth team assessment | Experimental | Other: interprofessional back pain assessmentTeam assessment for back pain with nurse practitioner and physical therapist via telehealth |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- chronic low back pain localized below costal margins and above gluteal folds and/or related leg pain, which is bad enough to limit their usual activities or daily routine and has been present for at least 3 months
Key exclusion criteria (1 listed)
- People with: third party payer insurance (i.e.worker's compensation board) for their back related complaints, with primarily neck or thoracic pain, and/ or with language, reading or comprehension barriers that would limit their ability to adequately complete the required study paperwork will be excluded from participating in the study.
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 |
|---|---|---|
| interprofessional back pain assessmentteam assessment and education with urban physical therapist and rural nurse practitioner via telehealth | Other | Telehealth team assessment |
Primary outcome
Patient experience with telehealth
Time frame: 2-4 weeks after assessment
Pain
Time frame: 2-4 weeks after assessment
Numeric Pain Rating Scale
Back-specific function
Time frame: 2-4 weeks after assessment
Modified Oswestry Disability Index
Participant satisfaction
Time frame: 2-4 weeks after assessment
Modified VSQ-9
1 secondary outcome
Health care provider experience
Time frame: within 2 weeks of completion of all assessments
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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing interprofessional back pain assessment in people with Back Pain Lower Back Chronic, 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 1 inclusion and 1 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. 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?
Patient experience with telehealth (time frame: 2-4 weeks after assessment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.