Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04261959 |
| Other study ID # |
H19-02567 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
February 18, 2020 |
| Est. completion date |
August 2, 2022 |
Study information
| Verified date |
November 2022 |
| Source |
University of British Columbia |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Marginalized populations are at increased risk of chronic pain, trauma and use of street
drugs to manage this suffering, with the associated risk of overdoses. Non-pharmacological
options to manage chronic pain are difficult for this population to access. myoActivation® is
an innovative structured assessment and therapeutic approach. This study will be conducted in
the Vancouver Community Primary Care Chronic Pain Service and will include myoActivation and
physiotherapy. The study will include sixty patients who seek care on a Tuesday, the only day
that myoActivation is offered, and will examine the impact of these treatments on pain
outcomes, function and quality of life.
Description:
Purpose: This study will evaluate the inclusion of myoActivation in primary care for
marginalized persons with concurrent opioid use disorder (OUD), chronic pain and trauma
history. The research aims to investigate whether myoActivation improves pain intensity,
quality of life, physical function, and reduces the need for prescribed analgesics (including
opioids) and reported illicit drug use.
Hypothesis: The investigators hypothesize that patients with chronic pain who are treated
with myoActivation will experience a reduction in pain and improvement in function and
quality of life as shown by a 30% reduction on the PEG score (Pain intensity, interference
with Enjoyment of life, interference with General activity) at 4, 12 and 24 weeks.
Justification: Chronic pain is typically treated by prescription of analgesic medications,
including opioids. However, many patients who have overdoses are using opioids and other
substances (including street drugs, alcohol, and marijuana) to manage chronic pain. There are
an inadequate number of effective non-pharmacological options to manage chronic pain and wait
lists for local Vancouver chronic pain clinics are as long as a year. Other treatment
modalities offered by the Vancouver Community pain service include physiotherapy, counselling
and group therapy.
Objectives: The investigators aim to demonstrate an improvement in pain intensity, quality of
life, and physical function as the primary outcomes. Secondary objectives include reduced
need for analgesic medications (including opioids) and illicit drug use.
Research Design: This study is a prospective, mixed method design, including 1:1
semi-structured patient interviews. It is an observational study: patients will NOT be
allocated to treatment on the basis of randomization or their enrollment in the study, i.e.
participants will receive routine clinical care, based on the services offered by the
clinical team at the pain clinic, and this will not change with their participation in the
study.
The study will involve recruitment of sixty patients who attend the pain service on Tuesdays,
when myoActivation and physiotherapy are offered, and who consent to being contacted for
follow up data collection and interviews. The aim is to recruit 20 patients receiving
myoActivation, 20 patients receiving physiotherapy and 20 patients receiving both
treatments.At the time of recruitment, the subset of patients who have concurrent opioid use
disorder, other addictions and / or trauma will not be known.
Data collection includes:
- a baseline score of the patients' pain experience using the validated questionnaires
PEG, Pain Catastrophizing Scale (PCS) and Pain Self-Efficacy Questionnaire (PSEQ).
- information on baseline mental health conditions - OUD, Trauma, Anxiety, Depression,
Axis 1
- PEG, PCS, PSEQ scores as well as the patient reported use of street drugs and pain
medications will be collected at 4, 12, 24 weeks using a study designed questionnaire
- a semi-structured 1:1 patient interview at 12-24 weeks will assess opioid/drug use, as
well as questions related to changes to housing, finances and overall health; this will
be conducted with 10 randomly selected participants who have received myoActivation.
Statistical Analysis: To allow for correlation of repeated data points on the same patient as
well as the anticipated variability in the number of data points for each patient, a linear
mixed-effects model will be used to analyze the quantitative data, including PEG score and
self-reported opioid use. A PEG score decrease of 30% will be taken to indicate an improved
pain experience. The PCS and PSEQ scores will be used to interpret the severity and change of
an individual's pain score.
The patient interview responses will be collated for common themes and used to augment the
quantitative data outcomes. Interviews will be recorded and transcribed. Thematic analysis
will be used to identify key words and phrases, list noted benefits of the service, potential
problems raised and any preferences expressed by participants with respect to the way the
treatment is administered.
