Clinical Trials Logo

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.


Recruitment information / eligibility

Status Completed
Enrollment 41
Est. completion date August 2, 2022
Est. primary completion date August 2, 2022
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

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
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).

Locations

Country Name City State
Canada Vancouver Community Pain Service, 524 East Pender Street Vancouver British Columbia

Sponsors (3)

Lead Sponsor Collaborator
University of British Columbia BC Children's Hospital Research Institute, Vancouver Coastal Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 4 weeks
Primary 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. 12 weeks
Primary 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. 24 weeks
Secondary 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. 4 weeks
Secondary 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. 12 weeks
Secondary 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. 24 weeks
Secondary 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. 4 weeks
Secondary 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. 12 weeks
Secondary 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. 24 weeks
Secondary 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. 4 weeks
Secondary 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. 12 weeks
Secondary 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. 24 weeks
See also
  Status Clinical Trial Phase
Completed NCT05452499 - Pain Neuroscience Education and Therapeutic Exercise as a Treatment for Breast Cancer Survivors Living With Sequelae N/A
Recruiting NCT05037682 - Pain and Opioid Management in Older Adults N/A
Completed NCT04080037 - Assessing Opioid Care Practices Using CPV Patient Simulation Modules N/A
Recruiting NCT05382962 - iCanCope With Post-Operative Pain (iCanCope PostOp) N/A
Recruiting NCT04285112 - SPRINT: Signature for Pain Recovery IN Teens
Active, not recruiting NCT04850079 - EHR Precision Drug Treatment in Neonates
Completed NCT03272139 - Interscalene Block Versus Superior Trunk Block Phase 4
Completed NCT03271151 - Effect of Duloxetine on Opioid Use After Total Knee Arthroplasty Phase 4
Completed NCT03886142 - Platelet Rich Plasma Versus Radio Frequency for Chronic Knee Arthritis N/A
Recruiting NCT05761392 - APP-based Precise Management System of Chronic Intractable Pain N/A
Recruiting NCT05877157 - Pain AND Opioids After Surgery
Completed NCT03947749 - Linking Epigenomics With Prescription Opioid Abuse and High Impact Musculoskeletal Pain
Completed NCT03280017 - Ketamine With Multilevel Paravertebral Block for Post Video-assisted Thoracic Surgery Pain Phase 4
Recruiting NCT04874038 - Prevention of Persistent Pain With LidocAine iNfusions in Breast Cancer Surgery (PLAN) Phase 3
Completed NCT04280796 - Changes in Affective Pain Processing in Human Volunteers N/A
Withdrawn NCT05125978 - Efficacy and Safety of Canadá Association in the Treatment of Chronic Pain Phase 2
Not yet recruiting NCT04328805 - Pain Reduction and Changes in Upper Limb Function Produced by an Ibuprofen Treatment in Carpal Tunnel Syndrome. Phase 4
Completed NCT04976738 - A Study of Cybis™ 10:25 THC:CBD Oil in Adults With Chronic Back/Neck Pain Phase 1/Phase 2
Completed NCT04089618 - Meditation Based Lifestyle Modification in Chronic Pain N/A
Recruiting NCT05699837 - Alpha Entrainment for Pain and Sleep (Extension) N/A