Access to Chiropractic Care ServicesNCT04666779
Access to Chiropractic Care During the COVID-19 Pandemic
An observational study of Access to Chiropractic Care Services, run by Real Centro Universitario Maria Cristina at 1 site in Spain.
Trial summary
This is a prospective comparative cohort trial taking place during the first year of the Coronavirus-19 (COVID-19) pandemic in Spain. Chiropractic patients throughout Spain were invited to participate independently of the care received, including patients who had stopped visiting their chiropractors since the pandemic… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Access to Chiropractic Care Services
- What is being tested?
- Chiropractic care
- How many people
- 399 participants
- Where
- 1 siteSpain
- Study dates
- 18 Dec 2020to 15 Sep 2021
- How long will I take part?
- 6 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Chiropractic patients when the pandemic hit in Spain (March 2020), who consulted a chiropractor for pain as one of the chief complaints (not necessarily the main or the only one)
Who may be able to join
- chiropractic patients with pain, active when lockdown was declared, over the age of 16
Who cannot join
- new patients in the clinic after the pandemic hit
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Access to Chiropractic Care During the COVID-19 Pandemic: a Prospective Comparative Cohort Trial
This is a prospective comparative cohort trial taking place during the first year of the Coronavirus-19 (COVID-19) pandemic in Spain. Chiropractic patients throughout Spain were invited to participate independently of the care received, including patients who had stopped visiting their chiropractors since the pandemic hit. The main exposure variable is the access to chiropractic care services, and the degree of this exposure during the months following initial lockdown phase in Spain. Participants will fill an online questionnaire with self-reported outcome-measures.
- Conditions
- Access to Chiropractic Care Services
- Being tested
- Chiropractic care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chiropractic careOther
Care provided by chiropractors, based on manual therapy, exercise prescription and patient advice/education/reassurance
| Study group | Role | What they receive |
|---|---|---|
| No access | Group not accessing chiropractic care | |
| Access to care | Group with access to care in a 6 months period. Differences in the degree of access, measured in ranges of numbers of visits, will be used as independent variable within this group. Receives: Other: Chiropractic care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Numerical Rating Scale (0-10, 0=no pain, 10=maximum pain)
Measured: 6 months
Pain duration
Duration of pain symptoms, PREVIOUS to the study, measured in months (up to 3 months, more than 3 months)
Measured: 6 months
Pain frequency
Ranges: Constant, every day, every week, occasionally
Measured: 6 months
Pain perceived improvement
Categories: New pain, worsened, no change, improv, gone
Measured: 6 months
Pain interference
From the Brief Pain Inventory (7 items, 0-10: 0= minimal score, 70=maximal score)
Measured: 6 months
Pain Catastrophizing Scale
Validated questionnaire (short version 4 items, 1-4: 4= minimal score, 16=maximal score)
Measured: 6 months
Tampa Scale Kinesiophobia
Validated questionnaire (short version 11 items, 0-3: 0=minimal score, 33=maximal score)
Measured: 6 months
Secondary outcomes (2)
General Anxiety Disorder scale
Validated questionnaire (7 items , 1-3: 1= minimal score, 21=maximal score)
Measured: 6 months
Fear of Illness and Virus Evaluation
Questionnaire (12 items, 1-4: 1=minimal score, 48=maximal score)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2020
- Study start18 Dec 2020
- Primary completion21 Feb 2021
- Study completion15 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Access to Chiropractic Care ServicesStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 399 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Real Centro Universitario Maria Cristina
- Sponsor type
- University, hospital or other
- Collaborators
- University of Birmingham, Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz, Université du Québec à Trois-Rivières
- Responsible party
- Sponsor
- Investigators
- Arantxa Ortega de Mues, PhD, Principal investigator, Real Centro Universitario María Cristina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04666779
- Sponsor's protocol ID
- CohortChiroCOVID19
- Status last verified
- Sep 2021
- First submitted
- 11 Dec 2020
- Last updated
- 16 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: All collected IPD will be shared, the format is yet to be decided.
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Access to Chiropractic Care During the COVID-19 Pandemic: a Prospective Comparative Cohort Trial
- ClinicalTrials.gov ID
- NCT04666779
- Acronym / sponsor ID
- CohortChiroCOVID19
- Conditions
- Access to Chiropractic Care Services
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 399 participants (actual)
- Lead sponsor
- Real Centro Universitario Maria CristinaUniversity, hospital or other
- Collaborators
- University of Birmingham, Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz, Université du Québec à Trois-Rivières
- Study start
- 18 Dec 2020 (actual)
- Primary completion
- 21 Feb 2021 (actual)
- Study completion
- 15 Sep 2021 (actual)
- First posted
- 14 Dec 2020 (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.
This is a prospective comparative cohort trial taking place during the first year of the Coronavirus-19 (COVID-19) pandemic in Spain. Chiropractic patients throughout Spain were invited to participate independently of the care received, including patients who had stopped visiting their chiropractors since the pandemic hit. The main exposure variable is the access to chiropractic care services, and the degree of this exposure during the months following initial lockdown phase in Spain. Participants will fill an online questionnaire with self-reported outcome-measures.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No access | – | –Group not accessing chiropractic care |
| Access to care | – | Other: Chiropractic careGroup with access to care in a 6 months period. Differences in the degree of access, measured in ranges of numbers of visits, will be used as independent variable within this group. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Chiropractic patients when the pandemic hit in Spain (March 2020), who consulted a chiropractor for pain as one of the chief complaints (not necessarily the main or the only one)
Key inclusion criteria (1 listed)
- chiropractic patients with pain, active when lockdown was declared, over the age of 16
Key exclusion criteria (1 listed)
- new patients in the clinic after the pandemic hit
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 |
|---|---|---|
| Chiropractic careCare provided by chiropractors, based on manual therapy, exercise prescription and patient advice/education/reassurance | Other | Access to care |
Primary outcome
Pain intensity
Time frame: 6 months
Numerical Rating Scale (0-10, 0=no pain, 10=maximum pain)
Pain duration
Time frame: 6 months
Duration of pain symptoms, PREVIOUS to the study, measured in months (up to 3 months, more than 3 months)
Pain frequency
Time frame: 6 months
Ranges: Constant, every day, every week, occasionally
Pain perceived improvement
Time frame: 6 months
Categories: New pain, worsened, no change, improv, gone
Pain interference
Time frame: 6 months
From the Brief Pain Inventory (7 items, 0-10: 0= minimal score, 70=maximal score)
Pain Catastrophizing Scale
Time frame: 6 months
Validated questionnaire (short version 4 items, 1-4: 4= minimal score, 16=maximal score)
Tampa Scale Kinesiophobia
Time frame: 6 months
Validated questionnaire (short version 11 items, 0-3: 0=minimal score, 33=maximal score)
2 secondary outcomes
General Anxiety Disorder scale
Time frame: 6 months
Fear of Illness and Virus Evaluation
Time frame: 6 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 16 Sep 2021.
- Individual participant dataSharing planned: Undecided. All collected IPD will be shared, the format is yet to be decided.
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.
Arantxa Ortega de Mues, PhD principal investigator
Real Centro Universitario María Cristina
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 Access to Chiropractic Care Services, run by Real Centro Universitario Maria Cristina at 1 site in Spain.
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 1 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 16 Sep 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 Spain. 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?
Pain intensity (time frame: 6 months). The study lists 7 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 16 Sep 2021.