Musculoskeletal PainSYMBIOMENCT02711085
Modeling Post-traumatic Pain and Recovery: The SYMBIOME Longitudinal Cohort Study
An observational study of Musculoskeletal Pain and Injuries, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
This study will explore the contribution of stress-system activity to pain and functional disability in the acute stage of traumatic musculoskeletal injury, and to the maintenance of symptoms after 3, 6 and 12 months post-injury. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Musculoskeletal Pain, Injuries
- How many people
- 134 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2015to Dec 2020
- How long will I take part?
- 12 Months
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults aged 18 or over presenting for issues of pain/limited function arising from acute (<3 weeks) injury affecting the musculoskeletal system that does not require hospital admission or surgery ('minor' injuries).
Who may be able to join
- Eligible participants:
- Will be aged 18 years or older
- Will be able to speak and understand conversational (grade 6) English
- Will be free of cognitive impairments that would interfere with ability to follow directions (e.g. diagnosed Alzheimer's Dementia, Down's Syndrome)
- Will be free of neuromuscular disorder that impairs mobility (e.g. stroke, multiple sclerosis, cerebral palsy, ALS)
- Will be free of active malignancies for the past 5 years
Show all 11Show fewer
- Will be free of systemic inflammatory conditions, including rheumatoid or psoriatic arthritis, scleroderma, or systemic lupus erythematosus
- Will not have been diagnosed with a concussion over the previous 6 months (including the current injury)
- Will not have been hospitalized overnight over the previous 6 months (including the current injury)
- Will not have taken steroid-based medications (either prescribed or self-administered) over the previous 6 months
- Will not have required surgical correction/relocation as a result of the trauma (e.g. open reduction/internal fixation of a fracture). -
Who cannot join
- Those who are under the influence of drugs or alcohol, or are otherwise not able to provide appropriate informed consent at the time of contact and those with no fixed address will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Systematic Merging of Biology, Mental Health and Environment (SYMBIOME) Longitudinal Databanking Project
This study will explore the contribution of stress-system activity to pain and functional disability in the acute stage of traumatic musculoskeletal injury, and to the maintenance of symptoms after 3, 6 and 12 months post-injury.
Read the detailed description
Purpose: The purpose of this protocol is to establish a longitudinal database of data collected from people having experienced an acute traumatic injury to their musculoskeletal system. This includes injuries commonly considered 'non-catastrophic' or 'minor' soft tissue injuries such as whiplash, low back injuries, sports or slip and fall-type injuries that result in sprain/strain of muscle, tendon, ligament or other such soft tissues. Uncomplicated bony fractures (those that are managed through casting only, non-surgical) will also comprise this cohort. The data will include biological specimens, psychological and cognitive profiles, and social/environmental indicators. This protocol represents the start of the SYStematic Merging of Biology, Mental health and Environment (SYMBIOME) project from the emerging Solving Traumatic pain and disability through Advanced Research Translation (START) research group centred at Western. Over time, this database will allow rich exploration of complex interactions between biology, psychology and environment as they relate to the resolution of traumatic pain and disability, or similarly the persistence thereof. Additional research ethics board (REB) applications will be submitted as those projects are ready to be formally conducted.
- Conditions
- Musculoskeletal Pain, Injuries
- Being tested
- No intervention
- Medical subject headings
- Musculoskeletal Pain, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention - observational study
| Study group | Role | What they receive |
|---|---|---|
| Acute trauma | Those within the first 3 weeks of a non-catastrophic injury affecting the musculoskeletal system, including but not limited to whiplash or other road-traffic collisions, sports injuries, work-related injuries, sprains, strains, slips and falls and non-displaced fractures that don't require surgical correction. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery change
Change in Satisfaction and Recovery Index
Measured: 1, 2, 3, 6, and 12 months
Functional Recovery
Brief Pain Inventory - Interference Subscale
Measured: 1, 2, 3, 6, 12 months
Secondary outcomes (4)
Change in Work status
Work status in relation to pre-injury status
Measured: 1, 2, 3, 6, and 12 months
Change in Pain
Numeric Rating Scale
Measured: 1, 2, 3, 6, and 12 months
Change in Post-traumatic Stress
PTSD Checklist
Measured: 1, 2, 3, 6, and 12 months
Change in Depressive Symptoms
Patient Health Questionnaire - 9
Measured: 1, 2, 3, 6, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2016 (estimated)
- Study startDec 2015
- Primary completionDec 2020
- Study completionDec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Musculoskeletal PainStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe 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
- 134 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Collaborators
- The Canadian Pain Society, Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02711085
- Sponsor's protocol ID
- 106140
- Acronym
- SYMBIOME
- Status last verified
- Dec 2018
- First submitted
- 16 Dec 2015
- Last updated
- 12 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: De-identified database will be made available on a cost-recovery basis as data accrue.
Publications
Modarresi S, MacDermid JC, Suh N, Elliott JM, Walton DM. How Is the Probability of Reporting Various Levels of Pain 12 Months After Noncatastrophic Injuries Associated with the Level of Peritraumatic Distress? Clin Orthop Relat Res. 2022 Feb 1;480(2):226-234. doi: 10.1097/CORR.0000000000002024.
PubMed 34705736Lee JY, Fakhereddin M, MacDermid JC, Elliott JM, Schabrun SM, Walton DM. An Exploration of Blood MarkerxEnvironment Interaction Effects on Pain Severity and Interference Scores in People With Acute Musculoskeletal Trauma. Clin J Pain. 2021 Oct 1;37(10):747-758. doi: 10.1097/AJP.0000000000000961.
PubMed 34292185Ghodrati M, Walton DM, MacDermid JC. Exploring the Domains of Gender as Measured by a New Gender, Pain and Expectations Scale. Womens Health Rep (New Rochelle). 2021 Apr 9;2(1):87-96. doi: 10.1089/whr.2020.0109. eCollection 2021.
PubMed 33937906Lee JY, Walton DM, Tremblay P, May C, Millard W, Elliott JM, MacDermid JC. Defining pain and interference recovery trajectories after acute non-catastrophic musculoskeletal trauma through growth mixture modeling. BMC Musculoskelet Disord. 2020 Sep 17;21(1):615. doi: 10.1186/s12891-020-03621-7.
PubMed 32943021
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Systematic Merging of Biology, Mental Health and Environment (SYMBIOME) Longitudinal Databanking Project
- ClinicalTrials.gov ID
- NCT02711085
- Acronym / sponsor ID
- SYMBIOME / 106140
- Conditions
- Musculoskeletal Pain, Injuries
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Collaborators
- The Canadian Pain Society, Canadian Institutes of Health Research (CIHR)
- Study start
- Dec 2015 (actual)
- Primary completion
- Dec 2020 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 17 Mar 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 study will explore the contribution of stress-system activity to pain and functional disability in the acute stage of traumatic musculoskeletal injury, and to the maintenance of symptoms after 3, 6 and 12 months post-injury.
Detailed description
Purpose: The purpose of this protocol is to establish a longitudinal database of data collected from people having experienced an acute traumatic injury to their musculoskeletal system. This includes injuries commonly considered 'non-catastrophic' or 'minor' soft tissue injuries such as whiplash, low back injuries, sports or slip and fall-type injuries that result in sprain/strain of muscle, tendon, ligament or other such soft tissues. Uncomplicated bony fractures (those that are managed through casting only, non-surgical) will also comprise this cohort. The data will include biological specimens, psychological and cognitive profiles, and social/environmental indicators. This protocol represents the start of the SYStematic Merging of Biology, Mental health and Environment (SYMBIOME) project from the emerging Solving Traumatic pain and disability through Advanced Research Translation (START) research group centred at Western. Over time, this database will allow rich exploration of complex interactions between biology, psychology and environment as they relate to the resolution of traumatic pain and disability, or similarly the persistence thereof. Additional research ethics board (REB) applications will be submitted as those projects are ready to be formally conducted.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute trauma | – | Other: No interventionThose within the first 3 weeks of a non-catastrophic injury affecting the musculoskeletal system, including but not limited to whiplash or other road-traffic collisions, sports injuries, work-related injuries, sprains, strains, slips and falls and non-displaced fractures that don't require surgical correction. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults aged 18 or over presenting for issues of pain/limited function arising from acute (<3 weeks) injury affecting the musculoskeletal system that does not require hospital admission or surgery ('minor' injuries).
Key inclusion criteria (11 listed)
- Will be aged 18 years or older
- Will be able to speak and understand conversational (grade 6) English
- Will be free of cognitive impairments that would interfere with ability to follow directions (e.g. diagnosed Alzheimer's Dementia, Down's Syndrome)
- Will be free of neuromuscular disorder that impairs mobility (e.g. stroke, multiple sclerosis, cerebral palsy, ALS)
- Will be free of active malignancies for the past 5 years
Key exclusion criteria (1 listed)
- Those who are under the influence of drugs or alcohol, or are otherwise not able to provide appropriate informed consent at the time of contact and those with no fixed address will be excluded.
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 |
|---|---|---|
| No interventionNo intervention - observational study | Other | Acute trauma |
Primary outcome
Recovery change
Time frame: 1, 2, 3, 6, and 12 months
Change in Satisfaction and Recovery Index
Functional Recovery
Time frame: 1, 2, 3, 6, 12 months
Brief Pain Inventory - Interference Subscale
4 secondary outcomes
Change in Work status
Time frame: 1, 2, 3, 6, and 12 months
Change in Pain
Time frame: 1, 2, 3, 6, and 12 months
Change in Post-traumatic Stress
Time frame: 1, 2, 3, 6, and 12 months
Change in Depressive Symptoms
Time frame: 1, 2, 3, 6, and 12 months
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 12 Aug 2021.
- Derived from this study: PubMed 34705736Modarresi S, MacDermid JC, Suh N, Elliott JM, Walton DM. How Is the Probability of Reporting Various Levels of Pain 12 Months After Noncatastrophic Injuries Associated with the Level of Peritraumatic Distress? Clin Orthop Relat Res. 2022 Feb 1;480(2):226-234. doi: 10.1097/CORR.0000000000002024.
- Derived from this study: PubMed 34292185Lee JY, Fakhereddin M, MacDermid JC, Elliott JM, Schabrun SM, Walton DM. An Exploration of Blood MarkerxEnvironment Interaction Effects on Pain Severity and Interference Scores in People With Acute Musculoskeletal Trauma. Clin J Pain. 2021 Oct 1;37(10):747-758. doi: 10.1097/AJP.0000000000000961.
- Derived from this study: PubMed 33937906Ghodrati M, Walton DM, MacDermid JC. Exploring the Domains of Gender as Measured by a New Gender, Pain and Expectations Scale. Womens Health Rep (New Rochelle). 2021 Apr 9;2(1):87-96. doi: 10.1089/whr.2020.0109. eCollection 2021.
- Derived from this study: PubMed 32943021Lee JY, Walton DM, Tremblay P, May C, Millard W, Elliott JM, MacDermid JC. Defining pain and interference recovery trajectories after acute non-catastrophic musculoskeletal trauma through growth mixture modeling. BMC Musculoskelet Disord. 2020 Sep 17;21(1):615. doi: 10.1186/s12891-020-03621-7.
- Individual participant dataSharing planned: Yes. De-identified database will be made available on a cost-recovery basis as data accrue.
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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?
An observational study of Musculoskeletal Pain and Injuries, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's 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 11 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 12 Aug 2021. 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?
Recovery change (time frame: 1, 2, 3, 6, and 12 months). The study lists 2 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 NCT02711085, which also lists 4 linked publications.
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 12 Aug 2021.