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

Sponsor
Real Centro Universitario Maria Cristina (Other)
Overall Status
Completed
CT.gov ID
NCT04573361
Collaborator
Université du Québec à Trois-Rivières (Other), University of Birmingham (Other)
723
1
3
25
880.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Chiropractic care (one visit)
  • Other: Chiropractic care (more than one visit)
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
723 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Three arms depending on the access to chiropractic care (no access, one visit or more than one) during the 14-days period of the trial. Measures were taken at the beginning and at the end of the 14-day period.Three arms depending on the access to chiropractic care (no access, one visit or more than one) during the 14-days period of the trial. Measures were taken at the beginning and at the end of the 14-day period.
Masking:
None (Open Label)
Masking Description:
Care was provided by chiropractors,
Primary Purpose:
Treatment
Official Title:
Access to Chiropractic Care During the State of Emergency Generated by the COVID-19 Pandemic in Spain: a Pragmatic Controlled Trial
Actual Study Start Date :
May 2, 2020
Actual Primary Completion Date :
May 27, 2020
Actual Study Completion Date :
May 27, 2020

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. Pain intensity [14 days]

      Numerical rating scale (0-10, 0 meaning no pain, 10 meaning worst pain imaginable)

    2. Pain frequency [14 days]

      Likert Scale from better (1) to worst (4) outcomes, 1: occasionally, 4: constantly

    3. Pain evolution [14 days]

      Likert Scale of self-perceived improvement, from better (1) to worst (5) outcomes, 1: much better, 5: much worse

    4. 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

    1. 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

    2. 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

    3. 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

    4. 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

    5. 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

    6. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    14 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Real Centro Universitario María Cristina San Lorenzo De El Escorial Madrid Spain 28200

    Sponsors and Collaborators

    • Real Centro Universitario Maria Cristina
    • 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 Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Real Centro Universitario Maria Cristina
    ClinicalTrials.gov Identifier:
    NCT04573361
    Other Study ID Numbers:
    • ChiroCOVID19
    First Posted:
    Oct 5, 2020
    Last Update Posted:
    Oct 5, 2020
    Last Verified:
    Sep 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 5, 2020