PainNCT03704883
Behavior of Cyclists in Response to Pain
An observational study of Pain and Sport Injury, run by Allina Health System at 1 site in United States.
Trial summary
A qualitative study, as a follow-up to an earlier study, that provides an opportunity to develop a deeper understanding of the injured cyclist's behavior related to seeking medical attention and endurance of pain. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pain, Sport Injury, Athletic Injuries
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2016to 1 Sep 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Club-level cyclists, recruited from a local bike shop, who have an injury and either have or have not sought medical attention.
Who may be able to join
- Have at least one year of cycling experience and will not compete in multi-sport events such as a triathlon.
- Have had an injury currently or in the recent past associated with biking and experiencing pain related to cycling injury(s).
- Must read and speak English.
Who cannot join
- Non-English speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407
About this study
Official title: Behavior of Cyclists in Response to Pain: a Qualitative Study
A qualitative study, as a follow-up to an earlier study, that provides an opportunity to develop a deeper understanding of the injured cyclist's behavior related to seeking medical attention and endurance of pain. This study includes 10 club-level cyclists who have an injury and either have or have not sought medical attention.
- Conditions
- Pain, Sport Injury, Athletic Injuries
- Keywords
- Cycling, Endurance, Pain, Injury
- Medical subject headings
- Pain, Athletic Injuries, Wounds and Injuries
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported experience of cycling-related pain
Key themes elicited from semi-structured interviews with participants. Themes will involve experiences related to cyclists' experience of pain and behavior related to pain, specifically the decision surrounding if and how to seek medical attention.
Measured: Up to 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2018
- Study start1 May 2016
- Primary completion1 Sep 2018
- Study completion1 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- 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 only
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allina Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie C Lesiz, DO, Principal investigator, Allina Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03704883
- Sponsor's protocol ID
- CKML-1601
- Status last verified
- Oct 2018
- First submitted
- 8 Oct 2018
- Last updated
- 15 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavior of Cyclists in Response to Pain: a Qualitative Study
- ClinicalTrials.gov ID
- NCT03704883
- Acronym / sponsor ID
- CKML-1601
- Conditions
- Pain, Sport Injury, Athletic Injuries
- Keywords
- Cycling, Endurance, Pain, Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Allina Health SystemUniversity, hospital or other
- Study start
- 1 May 2016 (actual)
- Primary completion
- 1 Sep 2018 (actual)
- Study completion
- 1 Sep 2018 (actual)
- First posted
- 15 Oct 2018 (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.
A qualitative study, as a follow-up to an earlier study, that provides an opportunity to develop a deeper understanding of the injured cyclist's behavior related to seeking medical attention and endurance of pain. This study includes 10 club-level cyclists who have an injury and either have or have not sought medical attention.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Club-level cyclists, recruited from a local bike shop, who have an injury and either have or have not sought medical attention.
Key inclusion criteria (3 listed)
- Have at least one year of cycling experience and will not compete in multi-sport events such as a triathlon.
- Have had an injury currently or in the recent past associated with biking and experiencing pain related to cycling injury(s).
- Must read and speak English.
Key exclusion criteria (1 listed)
- Non-English speaking
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
Self-reported experience of cycling-related pain
Time frame: Up to 30 minutes
Key themes elicited from semi-structured interviews with participants. Themes will involve experiences related to cyclists' experience of pain and behavior related to pain, specifically the decision surrounding if and how to seek medical attention.
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 15 Oct 2018.
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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.
Marie C Lesiz, DO principal investigator
Allina Health System
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 and Sport Injury, run by Allina Health System at 1 site in United States.
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 3 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 15 Oct 2018. 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 United States. 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?
Self-reported experience of cycling-related pain (time frame: Up to 30 minutes). 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 15 Oct 2018.