Access to Chiropractic Care During the COVID-19 Pandemic

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.

Study Overview

• Status: Completed
• Conditions: Access to Chiropractic Care Services
• Intervention / Treatment: Other: Chiropractic care

• Study Type: Observational
• Enrollment (Actual): 399

Contacts and Locations

Study Locations

• Spain
  • Madrid
    • San Lorenzo De El Escorial, Madrid, Spain, 28200
      • Real Centro Universitario María Cristina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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)

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: Chiropractic care; Care provided by chiropractors, based on manual therapy, exercise prescription and patient advice/education/reassurance

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity	Numerical Rating Scale (0-10, 0=no pain, 10=maximum pain)	6 months
Pain duration	Duration of pain symptoms, PREVIOUS to the study, measured in months (up to 3 months, more than 3 months)	6 months
Pain frequency	Ranges: Constant, every day, every week, occasionally	6 months
Pain perceived improvement	Categories: New pain, worsened, no change, improv, gone	6 months
Pain interference	From the Brief Pain Inventory (7 items, 0-10: 0= minimal score, 70=maximal score)	6 months
Pain Catastrophizing Scale	Validated questionnaire (short version 4 items, 1-4: 4= minimal score, 16=maximal score)	6 months
Tampa Scale Kinesiophobia	Validated questionnaire (short version 11 items, 0-3: 0=minimal score, 33=maximal score)	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
General Anxiety Disorder scale	Validated questionnaire (7 items , 1-3: 1= minimal score, 21=maximal score)	6 months
Fear of Illness and Virus Evaluation	Questionnaire (12 items, 1-4: 1=minimal score, 48=maximal score)	6 months

Collaborators and Investigators

• Sponsor: Real Centro Universitario Maria Cristina
• Collaborators: Université du Québec à Trois-Rivières; University of Birmingham; Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
• Investigators: Principal Investigator: Arantxa Ortega de Mues, PhD, Real Centro Universitario María Cristina

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2020
• Primary Completion (Actual): February 21, 2021
• Study Completion (Actual): September 15, 2021

Study Registration Dates

• First Submitted: December 11, 2020
• First Submitted That Met QC Criteria: December 11, 2020
• First Posted (Actual): December 14, 2020

Study Record Updates

• Last Update Posted (Actual): September 16, 2021
• Last Update Submitted That Met QC Criteria: September 14, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: CohortChiroCOVID19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: All collected IPD will be shared, the format is yet to be decided.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No