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

Access to Chiropractic Care During the State of Emergency Generated by the COVID-19 Pandemic in Spain: a Pragmatic Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Musculoskeletal Pain; Psychological Distress; Disability Physical
• Intervention / Treatment: Other: Chiropractic care (one visit); Other: Chiropractic care (more than one visit)

• Study Type: Interventional
• Enrollment (Actual): 723
• Phase: Not Applicable

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

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Group Control; Patients having no access to chiropractic treatment during the trial
Experimental: Group Chiropractic Care one session; Patients having access to in-person chiropractic treatment once during the trial	Other: 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; Other Names: Chiropractic Tx1
Experimental: Group Chiropractic Care multiple sessions; Patients having access to in-person chiropractic treatment more than once during the trial	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; Other Names: Chiropractic Tx2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity	Numerical rating scale (0-10, 0 meaning no pain, 10 meaning worst pain imaginable)	14 days
Pain frequency	Likert Scale from better (1) to worst (4) outcomes, 1: occasionally, 4: constantly	14 days
Pain evolution	Likert Scale of self-perceived improvement, from better (1) to worst (5) outcomes, 1: much better, 5: much worse	14 days
Pain interference	Validated subscale form the Brief Pain Inventory, 6 categories from 0 to 10 each, the lower, the better outcomes, out of a minimal of 0 and total of 60.	14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Catastrophizing Scale	Validated questionnaire. Short version 4 items, Likert scale from 0 to 4, lowest score (0) better outcomes, highest score (16) worst outcomes	14 days
Tampa Scale Kinesiophobia	Validated questionnaire. Short version 11 items, Likert scale from 1 to 4, lowest score (11) better outcomes, highest score (44) worst outcomes	14 days
General Anxiety Disorder scale	Validated questionnaire 7 items, Likert scale from 0 to 3, lowest score (0) better outcomes, highest score (21) worst outcomes	14 days
Intolerance of Uncertainty Scale	Validated questionnaire. Short version 12 items, Likert scale from 1 to 5, lowest score (12) better outcomes, highest score (60) worst outcomes	14 days
General Self-Efficacy scale	Validated questionnaire 10 items, Likert scale from 1 to 10, lowest score (10) WORST outcomes, highest score (100) BETTER outcomes	14 days
Fear of Illness and Virus Evaluation	Questionnaire, subscale 10 items, Likert scale from 1 to 4, lowest score (1) WORST outcomes, highest score (40) BETTER outcomes	14 days

Collaborators and Investigators

• Sponsor: Real Centro Universitario Maria Cristina
• Collaborators: Université du Québec à Trois-Rivières; University of Birmingham
• Investigators: Principal Investigator: Arantxa Ortega de Mues, PhD, Madrid College of Chiropractic - Real Centro Universitario Maria Cristina

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2020
• Primary Completion (Actual): May 27, 2020
• Study Completion (Actual): May 27, 2020

Study Registration Dates

• First Submitted: September 29, 2020
• First Submitted That Met QC Criteria: September 30, 2020
• First Posted (Actual): October 5, 2020

Study Record Updates

• Last Update Posted (Actual): October 5, 2020
• Last Update Submitted That Met QC Criteria: September 30, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Disease Attributes; Musculoskeletal Diseases; Muscular Diseases; Emergencies; Musculoskeletal Pain
• Other Study ID Numbers: ChiroCOVID19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: All collected IPD will be shared, though a next phase of the study is being debated, which is why we are still undecided.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No