Access to Chiropractic Care Services Clinical Trial
Official title:
Access to Chiropractic Care During the COVID-19 Pandemic: a Prospective Comparative Cohort Trial
| Verified date | September 2021 |
| Source | Real Centro Universitario Maria Cristina |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational [Patient Registry] |
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.
| Status | Completed |
| Enrollment | 399 |
| Est. completion date | September 15, 2021 |
| Est. primary completion date | February 21, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 16 Years and older |
| Eligibility | Inclusion Criteria: - chiropractic patients with pain, active when lockdown was declared, over the age of 16 Exclusion Criteria: - new patients in the clinic after the pandemic hit |
| Country | Name | City | State |
|---|---|---|---|
| Spain | Real Centro Universitario María Cristina | San Lorenzo De El Escorial | Madrid |
| Lead Sponsor | Collaborator |
|---|---|
| Real Centro Universitario Maria Cristina | Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz, Université du Québec à Trois-Rivières, University of Birmingham |
Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Pain intensity | Numerical Rating Scale (0-10, 0=no pain, 10=maximum pain) | 6 months | |
| Primary | Pain duration | Duration of pain symptoms, PREVIOUS to the study, measured in months (up to 3 months, more than 3 months) | 6 months | |
| Primary | Pain frequency | Ranges: Constant, every day, every week, occasionally | 6 months | |
| Primary | Pain perceived improvement | Categories: New pain, worsened, no change, improv, gone | 6 months | |
| Primary | Pain interference | From the Brief Pain Inventory (7 items, 0-10: 0= minimal score, 70=maximal score) | 6 months | |
| Primary | Pain Catastrophizing Scale | Validated questionnaire (short version 4 items, 1-4: 4= minimal score, 16=maximal score) | 6 months | |
| Primary | Tampa Scale Kinesiophobia | Validated questionnaire (short version 11 items, 0-3: 0=minimal score, 33=maximal score) | 6 months | |
| Secondary | General Anxiety Disorder scale | Validated questionnaire (7 items , 1-3: 1= minimal score, 21=maximal score) | 6 months | |
| Secondary | Fear of Illness and Virus Evaluation | Questionnaire (12 items, 1-4: 1=minimal score, 48=maximal score) | 6 months |