Musculoskeletal PainPRiSMNCT02726464
Testing the Characteristics of Platelet Rich Plasma in Sports Medicine
An observational study of Musculoskeletal Pain and Osteoarthritis, run by University of British Columbia at 1 site in Canada.
Trial summary
This is an observational study that evaluates the characteristics of Platelet Rich Plasma used in the therapy and treatment of musculoskeletal injuries and degenerative joint diseases. Read more about this study
- Who is it for?
- Ages 19 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Musculoskeletal Pain, Osteoarthritis
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2016to Feb 2018
- 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 19 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population will consist of adults have been selected to receive platelet-rich plasma (PRP) injections as a treatment for musculoskeletal or degenerative joint conditions
Who may be able to join
- Are willing and able to give informed consent for participation in the study
- Have a diagnosed injury/condition requiring PRP injection: patients with acute or chronic musculoskeletal injury, tendinopathy, or mild to moderate osteoarthritis of the knee
- Are otherwise healthy
- Agree to pre-treatment fasting (4 hours prior to treatment)
- Agree to disclose medications taken in the last 2 weeks
- Able (in the Investigators opinion) and willing to comply with all study requirements
- Able to attend an on-site visit or provide information on your current status electronically, 3 and 6 weeks following the PRP injection
- Have not previously received a PRP injection for your current injury
Who cannot join
- Unable to provide informed consent
- Have any blood borne disease, currently or in the past
- Have a systemic inflammatory disease, skin or joint infection, bleeding disorders, or compromised immune function
- Have a known platelet abnormality or hematological disorder
- Are not able or willing to share with the study team any medications taken in the last two weeks.
- Taking anti-inflammatory medications or medications that interfere with clotting
Show all 9Show fewer
- Are female and are pregnant or breast feeding
- Have inadequate venous access for drawing blood
- Have any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the patients ability to participate in the study
Trial locations and contacts
1 site in 1 country.
Canada1 site
Allan McGavin Sports Medicine Centre
Vancouver, British Columbia, V6T1Z3
About this study
This is an observational study that evaluates the characteristics of Platelet Rich Plasma used in the therapy and treatment of musculoskeletal injuries and degenerative joint diseases.
A sample of the PRP will be tested for platelet and microparticle content using dynamic light scattering to determine if there is a relationship between the composition and the treatment outcome.
Read the detailed description
An observational study that evaluates the characteristics of Platelet Rich Plasma used in the therapy and treatment of musculoskeletal and degenerative joint conditions.
Patients enrolled in this study have already been assessed by the Principal Investigator and are schedule to receive treatment with Platelet Rich Plasma. Prior to the treatment patients will be asked to consent in the study where the composition of the PRP is to be evaluated. Consenting patients that meet inclusion/exclusion criteria will complete a pain score self-assessment prior to treatment.
An autologous preparation of PRP sample will be made from the subject's whole blood. The subject will receive the PRP treatment and an excess portion of the PRP preparation will be tested for composition and the relative concentration of the constituents.
The sample of the PRP will be tested using Dynamic Light Scattering (ThromboLUX System) to measure the constituents in PRP preparations prior to injection. PRP and whole blood (at physician's discretion) will be analyzed on a hematology analyzer.
The testing work-flow does not alter the subject's standard of care. The physician will be blinded to the analytical results during the enrolment, treatment and patient follow-up phase of the study. Analytical results are not used in patient management decisions.
Patient's response to the PRP treatment will be assessed at 3 and 6 weeks post injection. At these times, the clinical outcome of the treatment will be measured using a patient self -assessment (post-treatment pain scores).
This study will test the hypothesis that PRP characteristics, such as platelet and microparticle content and composition can be predictive clinical outcome for PRP treatments.
The clinical outcome will be evaluated by patient pre- and post-pain score assessment. This study aims to review clinical outcomes and compare these results against ThromboLUX and other test results. If the predictive value of platelet composition testing can be demonstrated, additional studies may be considered.
- Conditions
- Musculoskeletal Pain, Osteoarthritis
- Keywords
- Platelet-rich Plasma, Cell-Derived Microparticles, Pain Management, Blood Platelets, Therapeutics, Inflammation, ThromboLUX, Dynamic Light Scattering
- Medical subject headings
- Musculoskeletal Pain, Osteoarthritis, Agnosia, Inflammation
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pre- and post- pain score at 3 and 6 weeks
The primary objective of the study is to test the hypothesis that the constituents in platelet-rich plasma (PRP) preparations, such as platelet and microparticle content and composition, can be correlated to the clinical outcome for PRP treatments.
Measured: Up to 6 weeks after injection
The impact of microparticle content on pain scores
The study will ascertain the capability of ThromboLUX microparticle assay results to correlate with the clinical outcome for PRP treatments when evaluated by patient pre- and post-pain score assessment.
Measured: Up to 6 weeks after injection
Secondary outcomes (2)
Correlation of platelet count to ThromboLUX results
Evaluation of PRP platelet count to clinical outcome and ThromboLUX data outputs
Measured: Up to 6 weeks after injection
The use of dynamic light scattering (ThromboLUX) as a patient screening tool
To verify the performance of the ThromboLUX instrument in a clinical setting by reviewing size and composition of constituents in PRP
Measured: Up to 6 weeks after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2016 (estimated)
- Study startMar 2016
- Primary completionMar 2017 (estimated)
- Study completionFeb 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal PainStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- LightIntegra Technology
- Responsible party
- Sponsor
- Investigators
- Don McKenzie, MD, PhD, LLD, Principal investigator, University of British ColumbiaJennifer Leung, MSc, Study director, LightIntegra Technology Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02726464
- Sponsor's protocol ID
- H16-00328
- Acronym
- PRiSM
- Status last verified
- Feb 2017
- First submitted
- 29 Mar 2016
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Characteristics of Platelet Rich Plasma in Sports Medicine
- ClinicalTrials.gov ID
- NCT02726464
- Acronym / sponsor ID
- PRiSM / H16-00328
- Conditions
- Musculoskeletal Pain, Osteoarthritis
- Keywords
- Platelet-rich Plasma, Cell-Derived Microparticles, Pain Management, Blood Platelets, Therapeutics, Inflammation, ThromboLUX, Dynamic Light Scattering
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- LightIntegra Technology
- Study start
- Mar 2016
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Feb 2018 (estimated)
- First posted
- 1 Apr 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 is an observational study that evaluates the characteristics of Platelet Rich Plasma used in the therapy and treatment of musculoskeletal injuries and degenerative joint diseases.
A sample of the PRP will be tested for platelet and microparticle content using dynamic light scattering to determine if there is a relationship between the composition and the treatment outcome.
Detailed description
An observational study that evaluates the characteristics of Platelet Rich Plasma used in the therapy and treatment of musculoskeletal and degenerative joint conditions.
Patients enrolled in this study have already been assessed by the Principal Investigator and are schedule to receive treatment with Platelet Rich Plasma. Prior to the treatment patients will be asked to consent in the study where the composition of the PRP is to be evaluated. Consenting patients that meet inclusion/exclusion criteria will complete a pain score self-assessment prior to treatment.
An autologous preparation of PRP sample will be made from the subject's whole blood. The subject will receive the PRP treatment and an excess portion of the PRP preparation will be tested for composition and the relative concentration of the constituents.
The sample of the PRP will be tested using Dynamic Light Scattering (ThromboLUX System) to measure the constituents in PRP preparations prior to injection. PRP and whole blood (at physician's discretion) will be analyzed on a hematology analyzer.
The testing work-flow does not alter the subject's standard of care. The physician will be blinded to the analytical results during the enrolment, treatment and patient follow-up phase of the study. Analytical results are not used in patient management decisions.
Patient's response to the PRP treatment will be assessed at 3 and 6 weeks post injection. At these times, the clinical outcome of the treatment will be measured using a patient self -assessment (post-treatment pain scores).
This study will test the hypothesis that PRP characteristics, such as platelet and microparticle content and composition can be predictive clinical outcome for PRP treatments.
The clinical outcome will be evaluated by patient pre- and post-pain score assessment. This study aims to review clinical outcomes and compare these results against ThromboLUX and other test results. If the predictive value of platelet composition testing can be demonstrated, additional studies may be considered.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of adults have been selected to receive platelet-rich plasma (PRP) injections as a treatment for musculoskeletal or degenerative joint conditions
Key inclusion criteria (8 listed)
- Are willing and able to give informed consent for participation in the study
- Have a diagnosed injury/condition requiring PRP injection: patients with acute or chronic musculoskeletal injury, tendinopathy, or mild to moderate osteoarthritis of the knee
- Are otherwise healthy
- Agree to pre-treatment fasting (4 hours prior to treatment)
- Agree to disclose medications taken in the last 2 weeks
Key exclusion criteria (9 listed)
- Unable to provide informed consent
- Have any blood borne disease, currently or in the past
- Have a systemic inflammatory disease, skin or joint infection, bleeding disorders, or compromised immune function
- Have a known platelet abnormality or hematological disorder
- Are not able or willing to share with the study team any medications taken in the last two weeks.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in pre- and post- pain score at 3 and 6 weeks
Time frame: Up to 6 weeks after injection
The primary objective of the study is to test the hypothesis that the constituents in platelet-rich plasma (PRP) preparations, such as platelet and microparticle content and composition, can be correlated to the clinical outcome for PRP treatments.
The impact of microparticle content on pain scores
Time frame: Up to 6 weeks after injection
The study will ascertain the capability of ThromboLUX microparticle assay results to correlate with the clinical outcome for PRP treatments when evaluated by patient pre- and post-pain score assessment.
2 secondary outcomes
Correlation of platelet count to ThromboLUX results
Time frame: Up to 6 weeks after injection
The use of dynamic light scattering (ThromboLUX) as a patient screening tool
Time frame: Up to 6 weeks after injection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
- Individual participant dataSharing planned: Undecided
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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.
Don McKenzie, MD, PhD, LLD principal investigator
University of British Columbia
Jennifer Leung, MSc study director
LightIntegra Technology Inc
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 Osteoarthritis, 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 8 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 23 Feb 2017. 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?
Results are not available in the source record.
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?
Change in pre- and post- pain score at 3 and 6 weeks (time frame: Up to 6 weeks after injection). 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?
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 23 Feb 2017.