Back to resultsAccess to Chiropractic Care During the COVID-19 Healthcare Emergency in Spain
Primary Purpose
Musculoskeletal Pain, Disability Physical, Psychological Distress
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Chiropractic care (one visit)
Chiropractic care (more than one visit)
Sponsored by
About this trial
This is an interventional treatment trial for Musculoskeletal Pain
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
Sites / Locations
- Real Centro Universitario María Cristina
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Experimental
Arm Label
Group Control
Group Chiropractic Care one session
Group Chiropractic Care multiple sessions
Arm Description
Patients having no access to chiropractic treatment during the trial
Patients having access to in-person chiropractic treatment once during the trial
Patients having access to in-person chiropractic treatment more than once during the trial
Outcomes
Primary Outcome Measures
Pain intensity
Numerical rating scale (0-10, 0 meaning no pain, 10 meaning worst pain imaginable)
Pain frequency
Likert Scale from better (1) to worst (4) outcomes, 1: occasionally, 4: constantly
Pain evolution
Likert Scale of self-perceived improvement, from better (1) to worst (5) outcomes, 1: much better, 5: much worse
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.
Secondary Outcome Measures
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
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
General Anxiety Disorder scale
Validated questionnaire 7 items, Likert scale from 0 to 3, lowest score (0) better outcomes, highest score (21) worst outcomes
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
General Self-Efficacy scale
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
Questionnaire, subscale 10 items, Likert scale from 1 to 4, lowest score (1) WORST outcomes, highest score (40) BETTER outcomes
Full Information
NCT ID
NCT04573361
First Posted
September 29, 2020
Last Updated
September 30, 2020
Sponsor
Real Centro Universitario Maria Cristina
Collaborators
Université du Québec à Trois-Rivières, University of Birmingham
1. Study Identification
Unique Protocol Identification Number
NCT04573361
Brief Title
Access to Chiropractic Care During the COVID-19 Healthcare Emergency in Spain
Official Title
Access to Chiropractic Care During the State of Emergency Generated by the COVID-19 Pandemic in Spain: a Pragmatic Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
May 2, 2020 (Actual)
Primary Completion Date
May 27, 2020 (Actual)
Study Completion Date
May 27, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Real Centro Universitario Maria Cristina
Collaborators
Université du Québec à Trois-Rivières, University of Birmingham
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Musculoskeletal Pain, Disability Physical, Psychological Distress
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Masking Description
Care was provided by chiropractors,
Allocation
Non-Randomized
Enrollment
723 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group Control
Arm Type
No Intervention
Arm Description
Patients having no access to chiropractic treatment during the trial
Arm Title
Group Chiropractic Care one session
Arm Type
Experimental
Arm Description
Patients having access to in-person chiropractic treatment once during the trial
Arm Title
Group Chiropractic Care multiple sessions
Arm Type
Experimental
Arm Description
Patients having access to in-person chiropractic treatment more than once during the trial
Intervention Type
Other
Intervention Name(s)
Chiropractic care (one visit)
Other Intervention Name(s)
Chiropractic Tx1
Intervention Description
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
Intervention Name(s)
Chiropractic care (more than one visit)
Other Intervention Name(s)
Chiropractic Tx2
Intervention Description
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
Primary Outcome Measure Information:
Title
Pain intensity
Description
Numerical rating scale (0-10, 0 meaning no pain, 10 meaning worst pain imaginable)
Time Frame
14 days
Title
Pain frequency
Description
Likert Scale from better (1) to worst (4) outcomes, 1: occasionally, 4: constantly
Time Frame
14 days
Title
Pain evolution
Description
Likert Scale of self-perceived improvement, from better (1) to worst (5) outcomes, 1: much better, 5: much worse
Time Frame
14 days
Title
Pain interference
Description
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.
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Pain Catastrophizing Scale
Description
Validated questionnaire. Short version 4 items, Likert scale from 0 to 4, lowest score (0) better outcomes, highest score (16) worst outcomes
Time Frame
14 days
Title
Tampa Scale Kinesiophobia
Description
Validated questionnaire. Short version 11 items, Likert scale from 1 to 4, lowest score (11) better outcomes, highest score (44) worst outcomes
Time Frame
14 days
Title
General Anxiety Disorder scale
Description
Validated questionnaire 7 items, Likert scale from 0 to 3, lowest score (0) better outcomes, highest score (21) worst outcomes
Time Frame
14 days
Title
Intolerance of Uncertainty Scale
Description
Validated questionnaire. Short version 12 items, Likert scale from 1 to 5, lowest score (12) better outcomes, highest score (60) worst outcomes
Time Frame
14 days
Title
General Self-Efficacy scale
Description
Validated questionnaire 10 items, Likert scale from 1 to 10, lowest score (10) WORST outcomes, highest score (100) BETTER outcomes
Time Frame
14 days
Title
Fear of Illness and Virus Evaluation
Description
Questionnaire, subscale 10 items, Likert scale from 1 to 4, lowest score (1) WORST outcomes, highest score (40) BETTER outcomes
Time Frame
14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arantxa Ortega de Mues, PhD
Organizational Affiliation
Madrid College of Chiropractic - Real Centro Universitario Maria Cristina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Real Centro Universitario María Cristina
City
San Lorenzo De El Escorial
State/Province
Madrid
ZIP/Postal Code
28200
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing 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.
Learn more about this trial
Access to Chiropractic Care During the COVID-19 Healthcare Emergency in Spain
We'll reach out to this number within 24 hrs