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

Not Applicable

Completed

• Conditions: Disability Physical; Musculoskeletal Pain; Psychological Distress
• Interventions: Other: Chiropractic care (one visit); Other: Chiropractic care (more than one visit)

• Registration Number: NCT04573361
• Lead Sponsor: Real Centro Universitario Maria Cristina

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-05-02
• Primary Completion: 2020-05-27
• Study Completion: 2020-05-27
• Status Verified: 2020-09
• Study First Submitted: 2020-09-29
• Study First Submitted QC: 2020-09-30
• Last Update Submitted: 2020-09-30
• Study First Posted: 2020-10-05
• Last Update Posted: 2020-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 723

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group Chiropractic Care one session	Chiropractic care (one visit)	Patients having access to in-person chiropractic treatment once during the trial
Group Chiropractic Care multiple sessions	Chiropractic care (more than one visit)	Patients having access to in-person chiropractic treatment more than once during the trial

Primary Outcome Measures

Name	Time	Method
Pain intensity	14 days	Numerical rating scale (0-10, 0 meaning no pain, 10 meaning worst pain imaginable)
Pain frequency	14 days	Likert Scale from better (1) to worst (4) outcomes, 1: occasionally, 4: constantly
Pain evolution	14 days	Likert Scale of self-perceived improvement, from better (1) to worst (5) outcomes, 1: much better, 5: much worse
Pain interference	14 days	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Real Centro Universitario María Cristina; 🇪🇸 San Lorenzo De El Escorial, Madrid, Spain