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

Musculoskeletal Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04573361
• Other study ID #: ChiroCOVID19
• Status: Completed
• Phase: N/A
• Start date: May 2, 2020
• Est. completion date: May 27, 2020

Study information

• Verified date: September 2020
• Source: Real Centro Universitario Maria Cristina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 723
• Est. completion date: May 27, 2020
• Est. primary completion date: May 27, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Disability Physical
• Emergencies
• Musculoskeletal Pain
• Psychological Distress

Intervention

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
• 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

Locations

Country	Name	City	State
Spain	Real Centro Universitario María Cristina	San Lorenzo De El Escorial	Madrid

Sponsors (3)

Lead Sponsor	Collaborator
Real Centro Universitario Maria Cristina	Université du Québec à Trois-Rivières, University of Birmingham

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain intensity	Numerical rating scale (0-10, 0 meaning no pain, 10 meaning worst pain imaginable)	14 days
Primary	Pain frequency	Likert Scale from better (1) to worst (4) outcomes, 1: occasionally, 4: constantly	14 days
Primary	Pain evolution	Likert Scale of self-perceived improvement, from better (1) to worst (5) outcomes, 1: much better, 5: much worse	14 days
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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