Access to Chiropractic Care During the COVID-19 Pandemic

NCT04666779 | Completed

• 1 other identifier: CohortChiroCOVID19
• Study Type: observational
• Target: 399
• Locations: 1 country
• Sites: 1

Brief 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 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

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (2)

• General Anxiety Disorder scale

  6 months

• Fear of Illness and Virus Evaluation

  6 months

Study Arms (2)

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

Interventions

Chiropractic care OTHER

Care provided by chiropractors, based on manual therapy, exercise prescription and patient advice/education/reassurance

Access to care

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• chiropractic patients with pain, active when lockdown was declared, over the age of 16

You may not qualify if:

• new patients in the clinic after the pandemic hit

Sponsors & Collaborators

• Real Centro Universitario Maria Cristina: lead
• University of Birmingham: collaborator
• Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz: collaborator
• Université du Québec à Trois-Rivières: collaborator

Study Sites (1)

Real Centro Universitario María Cristina

El Escorial, Madrid, 28200, Spain

Location

Study Officials

• Arantxa Ortega de Mues, PhD

  Real Centro Universitario María Cristina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2020
• First Posted: December 14, 2020
• Study Start: December 18, 2020
• Primary Completion: February 21, 2021
• Study Completion: September 15, 2021
• Last Updated: September 16, 2021

Record last verified: 2021-09

Locations

ES (1)