Pain, ChronicNCT04261959
myoActivation® for Chronic Pain in a Marginalized Population
An observational study of Pain, Chronic and Widespread Chronic Pain, run by University of British Columbia at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pain, Chronic, Widespread Chronic Pain
- What is being tested?
- myoActivation
- How many people
- 41 participants
- Where
- 1 siteCanada
- Study dates
- 18 Feb 2020to 2 Aug 2022
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Structurally vulnerable persons (i.e. within marginalized populations) with chronic pain, and typically also mental health issues, substance use disorders, physical and emotional trauma.
Who may be able to join
- Any English-speaking patient with myofascial related chronic pain lasting >3 months, referred to the Vancouver Community (VC) chronic pain service by primary care.
Who cannot join
- Any patient who has received any of the following pain interventions or treatment in the 3 months preceding recruitment/intake to the pain service:
- Intramuscular Stimulation (IMS);
- Trigger Point Injection (TPI) with or without injectate;
- External physiotherapy (i.e. outside the service offered at VC pain clinic);
- Massage;
- Joint injection;
Show all 10Show fewer
- Chiropractic;
- Acupuncture;
- Group counselling at VC Pain Service (or has an existing appointment to attend Group counselling).
- (note, exclusion list does not include pain medications or opioid replacement therapy; also note, patients who subsequently access the VC Pain Service Group counselling will continue to be included in the study)
Trial locations and contacts
1 site in 1 country.
Canada1 site
Vancouver Community Pain Service, 524 East Pender Street
Vancouver, British Columbia, V6A 1V3
About this study
Official title: Longitudinal Analysis of an Innovative Non-Pharmacological Intervention for Chronic Pain in a Marginalized Population: A Prospective Pilot Study of myoActivation
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 Pain Service and will will examine the impact of this treatment on pain outcomes, function and quality of life.
Read the detailed 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 and counselling.
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 40 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. 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.
- Conditions
- Pain, Chronic, Widespread Chronic Pain
- Being tested
- myoActivation
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
myoActivationOther
myoActivation is a novel, structured assessment and non-pharmacological therapeutic approach to both diagnosis and treatment of chronic myofascial pain. A detailed history of the timeline of lifetime trauma combined with a quick, structured and reproducible set of posture and movement tests help to easily identify myofascial components of chronic pain. The therapeutic component is delivered utilizing a needling technique, or myofascial release, focused to active myofascial trigger points, fascia in tension and tethered scars.
| Study group | Role | What they receive |
|---|---|---|
| myoActivation and other pain services | Participants who receive one or more sessions of myoActivation. They may receive 1:1 counselling and physiotherapy also. Receives: Other: myoActivation |
What is being measured
The primary outcome is the main question the study is designed to answer.
PEG score wk 4
PEG is a validated self-report measure of (1) Pain intensity, (2) interference with Enjoyment of life, (3) interference with General activity. Each of the 3 dimensions is scored on a 0-10 scale. Total score is the average (mean) of the 3 values, minimum 0, maximum 10, lower score indicates a better outcome.
Measured: 4 weeks
PEG score wk 12
PEG is a validated self-report measure of (1) Pain intensity, (2) interference with Enjoyment of life, (3) interference with General activity. Each of the 3 dimensions is scored on a 0-10 scale. Total score is the average (mean) of the 3 values, minimum 0, maximum 10, lower score indicates a better outcome.
Measured: 12 weeks
PEG score wk 24
PEG is a validated self-report measure of (1) Pain intensity, (2) interference with Enjoyment of life, (3) interference with General activity. Each of the 3 dimensions is scored on a 0-10 scale. Total score is the average (mean) of the 3 values, minimum 0, maximum 10, lower score indicates a better outcome.
Measured: 24 weeks
Secondary outcomes (9)
PCS score wk 4
Pain Catastrophizing Scale (PCS) is a validated self-report scale that measures a person's cognitive-affective response to pain including the person's sense of helplessness, rumination and magnification of pain. Each of 13 dimensions are scored 0-4. The total score is the sum of these dimensions, minimum 0, maximum 52, lower score indicates a better outcome.
Measured: 4 weeks
PCS score wk 12
Pain Catastrophizing Scale (PCS) is a validated self-report scale that measures a person's cognitive-affective response to pain including the person's sense of helplessness, rumination and magnification of pain. Each of 13 dimensions are scored 0-4. The total score is the sum of these dimensions, minimum 0, maximum 52, lower score indicates a better outcome.
Measured: 12 weeks
PCS score wk 24
Pain Catastrophizing Scale (PCS) is a validated self-report scale that measures a person's cognitive-affective response to pain including the person's sense of helplessness, rumination and magnification of pain. Each of 13 dimensions are scored 0-4. The total score is the sum of these dimensions, minimum 0, maximum 52, lower score indicates a better outcome.
Measured: 24 weeks
PSEQ score wk 4
Pain Self-Efficacy Questionnaire (PSEQ) is a validated self-report scale, designed to assess the confidence people with ongoing pain have in performing activities while in pain. Each of 4 dimensions is scored 0-6. The total score is the sum of these dimensions, minimum 0, maximum 24, lower score indicates a worse outcome.
Measured: 4 weeks
PSEQ score wk 12
Pain Self-Efficacy Questionnaire (PSEQ) is a validated self-report scale, designed to assess the confidence people with ongoing pain have in performing activities while in pain. Each of 4 dimensions is scored 0-6. The total score is the sum of these dimensions, minimum 0, maximum 24, lower score indicates a worse outcome.
Measured: 12 weeks
PSEQ score wk 24
Pain Self-Efficacy Questionnaire (PSEQ) is a validated self-report scale, designed to assess the confidence people with ongoing pain have in performing activities while in pain. Each of 4 dimensions is scored 0-6. The total score is the sum of these dimensions, minimum 0, maximum 24, lower score indicates a worse outcome.
Measured: 24 weeks
Drug use wk 4
Patient reported use of street drugs and pain medications; whether participant is on opioid replacement therapy currently, or in the past.
Measured: 4 weeks
Drug use wk 12
Patient reported use of street drugs and pain medications; whether participant is on opioid replacement therapy currently, or in the past.
Measured: 12 weeks
Drug use wk 24
Patient reported use of street drugs and pain medications; whether participant is on opioid replacement therapy currently, or in the past.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2020
- Study start18 Feb 2020
- Primary completion2 Aug 2022
- Study completion2 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain, ChronicStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Vancouver Coastal Health Research Institute, BC Children's Hospital Research Institute
- Responsible party
- Principal investigator, Barbara Eddy, University of British Columbia
- Investigators
- Barbara Eddy, Principal investigator, Vancouver Coastal Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04261959
- Sponsor's protocol ID
- H19-02567
- Status last verified
- Nov 2022
- First submitted
- 3 Feb 2020
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nguyen L, Eddy BL, West N, Bone JN, Currie LM, Lauder G. The Impact of a Novel Methodological Process for Needling Scars, Fascia, and Muscles in the Management of Myofascial Dysfunction and Chronic Pain in a Population Living With Social and Health Inequities: Quantitative Findings From a Longitudinal Observational Pilot Study. Pain Res Manag. 2025 Sep 28;2025:8567447. doi: 10.1155/prm/8567447. eCollection 2025.
PubMed 41058955
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Analysis of an Innovative Non-Pharmacological Intervention for Chronic Pain in a Marginalized Population: A Prospective Pilot Study of myoActivation
- ClinicalTrials.gov ID
- NCT04261959
- Acronym / sponsor ID
- H19-02567
- Conditions
- Pain, Chronic, Widespread Chronic Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Vancouver Coastal Health Research Institute, BC Children's Hospital Research Institute
- Study start
- 18 Feb 2020 (actual)
- Primary completion
- 2 Aug 2022 (actual)
- Study completion
- 2 Aug 2022 (actual)
- First posted
- 10 Feb 2020 (actual)
- 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.
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 Pain Service and will will examine the impact of this treatment on pain outcomes, function and quality of life.
Detailed 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 and counselling.
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 40 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. 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| myoActivation and other pain services | – | Other: myoActivationParticipants who receive one or more sessions of myoActivation. They may receive 1:1 counselling and physiotherapy also. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Structurally vulnerable persons (i.e. within marginalized populations) with chronic pain, and typically also mental health issues, substance use disorders, physical and emotional trauma.
Key inclusion criteria (1 listed)
- Any English-speaking patient with myofascial related chronic pain lasting >3 months, referred to the Vancouver Community (VC) chronic pain service by primary care.
Key exclusion criteria (10 listed)
- Any patient who has received any of the following pain interventions or treatment in the 3 months preceding recruitment/intake to the pain service:
- Intramuscular Stimulation (IMS);
- Trigger Point Injection (TPI) with or without injectate;
- External physiotherapy (i.e. outside the service offered at VC pain clinic);
- Massage;
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 |
|---|---|---|
| myoActivationmyoActivation is a novel, structured assessment and non-pharmacological therapeutic approach to both diagnosis and treatment of chronic myofascial pain. A detailed history of the timeline of lifetime trauma combined with a quick, structured and reproducible set of posture and movement tests help to easily identify myofascial components of chronic pain. The therapeutic component is delivered utilizing a needling technique, or myofascial release, focused to active myofascial trigger points, fascia in tension and tethered scars. | Other | myoActivation and other pain services |
Primary outcome
PEG score wk 4
Time frame: 4 weeks
PEG is a validated self-report measure of (1) Pain intensity, (2) interference with Enjoyment of life, (3) interference with General activity. Each of the 3 dimensions is scored on a 0-10 scale. Total score is the average (mean) of the 3 values, minimum 0, maximum 10, lower score indicates a better outcome.
PEG score wk 12
Time frame: 12 weeks
PEG is a validated self-report measure of (1) Pain intensity, (2) interference with Enjoyment of life, (3) interference with General activity. Each of the 3 dimensions is scored on a 0-10 scale. Total score is the average (mean) of the 3 values, minimum 0, maximum 10, lower score indicates a better outcome.
PEG score wk 24
Time frame: 24 weeks
PEG is a validated self-report measure of (1) Pain intensity, (2) interference with Enjoyment of life, (3) interference with General activity. Each of the 3 dimensions is scored on a 0-10 scale. Total score is the average (mean) of the 3 values, minimum 0, maximum 10, lower score indicates a better outcome.
9 secondary outcomes
PCS score wk 4
Time frame: 4 weeks
PCS score wk 12
Time frame: 12 weeks
PCS score wk 24
Time frame: 24 weeks
PSEQ score wk 4
Time frame: 4 weeks
PSEQ score wk 12
Time frame: 12 weeks
PSEQ score wk 24
Time frame: 24 weeks
Drug use wk 4
Time frame: 4 weeks
Drug use wk 12
Time frame: 12 weeks
Drug use wk 24
Time frame: 24 weeks
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 16 Sep 2025.
- Derived from this study: PubMed 41058955Nguyen L, Eddy BL, West N, Bone JN, Currie LM, Lauder G. The Impact of a Novel Methodological Process for Needling Scars, Fascia, and Muscles in the Management of Myofascial Dysfunction and Chronic Pain in a Population Living With Social and Health Inequities: Quantitative Findings From a Longitudinal Observational Pilot Study. Pain Res Manag. 2025 Sep 28;2025:8567447. doi: 10.1155/prm/8567447. eCollection 2025.
- Individual participant dataSharing planned: No
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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.
Barbara Eddy principal investigator
Vancouver Coastal Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, Chronic and Widespread Chronic Pain, run by University of British Columbia 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 10 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 16 Sep 2025. 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?
PEG score wk 4 (time frame: 4 weeks). The study lists 3 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 NCT04261959, which also lists 1 linked publication.
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 16 Sep 2025.