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myoActivation® for Chronic Pain in a Marginalized Population

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ClinicalTrials.gov Identifier: NCT04261959
Recruitment Status : Recruiting
First Posted : February 10, 2020
Last Update Posted : May 13, 2020
Sponsor:
Collaborators:
Vancouver Coastal Health Research Institute
BC Children's Hospital Research Institute
Information provided by (Responsible Party):
Barbara Eddy, University of British Columbia

Brief 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.

Condition or disease Intervention/treatment
Pain, Chronic Widespread Chronic Pain Other: myoActivation Other: Physiotherapy

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Longitudinal Analysis of an Innovative Non-Pharmacological Intervention for Chronic Pain in a Marginalized Population: A Prospective Pilot Study of myoActivation
Actual Study Start Date : February 18, 2020
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Group/Cohort Intervention/treatment
myoActivation only
Participants who receive one or more sessions of myoActivation. They may receive 1:1 counselling also, but will not receive physiotherapy or group counselling
Other: myoActivation
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.

Physiotherapy only
Participants who receive one or more sessions of physiotherapy. They may receive 1:1 counselling also, but will not receive myoActivation or group counselling
Other: Physiotherapy
Physiotherapy aims to reduce a patient's pain experience and increase their physical function through physical examination, diagnosis, prognosis, physical intervention, rehabilitation and education (including pain neurophysiology education).

myoActivation and Physiotherapy
Participants who receive one or more sessions of myoActivation AND one or more sessions of physiotherapy. They may receive 1:1 counselling also, but will not receive group counselling
Other: myoActivation
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.

Other: Physiotherapy
Physiotherapy aims to reduce a patient's pain experience and increase their physical function through physical examination, diagnosis, prognosis, physical intervention, rehabilitation and education (including pain neurophysiology education).




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. PCS score wk 4 [ Time Frame: 4 weeks ]
    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.

  2. PCS score wk 12 [ Time Frame: 12 weeks ]
    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.

  3. PCS score wk 24 [ Time Frame: 24 weeks ]
    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.

  4. PSEQ score wk 4 [ Time Frame: 4 weeks ]
    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.

  5. PSEQ score wk 12 [ Time Frame: 12 weeks ]
    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.

  6. PSEQ score wk 24 [ Time Frame: 24 weeks ]
    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.

  7. Drug use wk 4 [ Time Frame: 4 weeks ]
    Patient reported use of street drugs and pain medications; whether participant is on opioid replacement therapy currently, or in the past.

  8. Drug use wk 12 [ Time Frame: 12 weeks ]
    Patient reported use of street drugs and pain medications; whether participant is on opioid replacement therapy currently, or in the past.

  9. Drug use wk 24 [ Time Frame: 24 weeks ]
    Patient reported use of street drugs and pain medications; whether participant is on opioid replacement therapy currently, or in the past.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

Any English-speaking patient with myofascial related chronic pain lasting >3 months, referred to the Vancouver Community (VC) chronic pain service by primary care.

Exclusion Criteria:

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;
  • 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)


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04261959


Contacts
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Contact: Nicholas West +44 1903 713 981 nwest@bcchr.ca

Locations
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Canada, British Columbia
Vancouver Community Pain Service, 524 East Pender Street Recruiting
Vancouver, British Columbia, Canada, V6A 1V3
Contact: Barb Eddy         
Sponsors and Collaborators
University of British Columbia
Vancouver Coastal Health Research Institute
BC Children's Hospital Research Institute
Investigators
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Principal Investigator: Barbara Eddy Vancouver Coastal Health
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Responsible Party: Barbara Eddy, Associate Member in the UBC Department of Medicine, Division of Palliative Care, University of British Columbia
ClinicalTrials.gov Identifier: NCT04261959    
Other Study ID Numbers: H19-02567
First Posted: February 10, 2020    Key Record Dates
Last Update Posted: May 13, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations