Access to Chiropractic Care During the COVID-19 Healthcare Emergency in Spain

NCT ID: NCT04573361

Last Updated: 2020-10-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 723 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-02
• Study Completion Date: 2020-05-27

Brief Summary

This is a pragmatic controlled clinical trial taking place in the first phase of COVID-19 lockdown re-opening in Spain. Patients of 52 chiropractic clinics were invited to participate in a pseudo-random order (one out of every three contacted patients) as they were contacted to either schedule an appointment with their current chiropractor or not, depending on the clinic's and the patient's availability. Patients would receive chiropractic in-person care (one or more than one visits) or no care at all, for a two-week period. According to the care received, they were assigned to one of three groups (receiving no care, receiving care once, and more than once). Participants filled an online questionnaire with self-reported outcome-measures at the beginning of the two week period. A follow-up questionnaire was completed 14 days after.

Conditions

Musculoskeletal Pain; Disability Physical; Psychological Distress

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group Control

Patients having no access to chiropractic treatment during the trial

Group Type: NO_INTERVENTION

No interventions assigned to this group

Group Chiropractic Care one session

Patients having access to in-person chiropractic treatment once during the trial

Group Type: EXPERIMENTAL

Chiropractic care (one visit)

Intervention Type: OTHER

One visit to the chiropractor based on the use of spinal manipulative therapy, mobilization and other forms of manual therapy, exercise therapy, patient education, advice and reassurance

Group Chiropractic Care multiple sessions

Patients having access to in-person chiropractic treatment more than once during the trial

Group Type: EXPERIMENTAL

Chiropractic care (more than one visit)

Intervention Type: OTHER

More than one visit to the chiropractor based on the use of spinal manipulative therapy, mobilization and other forms of manual therapy, exercise therapy, patient education, advice and reassurance

Interventions

Chiropractic care (one visit)

One visit to the chiropractor based on the use of spinal manipulative therapy, mobilization and other forms of manual therapy, exercise therapy, patient education, advice and reassurance

Intervention Type: OTHER

Chiropractic care (more than one visit)

More than one visit to the chiropractor based on the use of spinal manipulative therapy, mobilization and other forms of manual therapy, exercise therapy, patient education, advice and reassurance

Intervention Type: OTHER

Other Intervention Names

Chiropractic Tx1; Chiropractic Tx2

Eligibility Criteria

Inclusion Criteria

• chiropractic patients active when lockdown was declared, over the age of 14

Exclusion Criteria

• new patients in the clinic, patients with no current pain at the time of the trial

• Minimum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Université du Québec à Trois-Rivières

OTHER

Sponsor Role: collaborator

University of Birmingham

OTHER

Sponsor Role: collaborator

Real Centro Universitario Maria Cristina

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Arantxa Ortega de Mues, PhD

Role: PRINCIPAL_INVESTIGATOR

Madrid College of Chiropractic - Real Centro Universitario Maria Cristina

Locations

Real Centro Universitario María Cristina

El Escorial, Madrid, Spain

Countries

Spain

Other Identifiers

ChiroCOVID19

Identifier Type: -

Identifier Source: org_study_id