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

NCT04573361 | Completed

• 1 other identifier: ChiroCOVID19
• Study Type: interventional
• Target: 723
• Locations: 1 country
• Sites: 1

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.

Conditions

Musculoskeletal Pain; Disability Physical; Psychological Distress

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (6)

• Pain Catastrophizing Scale

  14 days

• Tampa Scale Kinesiophobia

  14 days

• General Anxiety Disorder scale

  14 days

• Intolerance of Uncertainty Scale

  14 days

• General Self-Efficacy scale

  14 days

Study Arms (3)

Group Control

NO INTERVENTION

Patients having no access to chiropractic treatment during the trial

Group Chiropractic Care one session

EXPERIMENTAL

Patients having access to in-person chiropractic treatment once during the trial

Other: Chiropractic care (one visit)

Group Chiropractic Care multiple sessions

EXPERIMENTAL

Patients having access to in-person chiropractic treatment more than once during the trial

Other: Chiropractic care (more than one visit)

Interventions

Chiropractic care (one visit) OTHER

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

Also known as: Chiropractic Tx1

Group Chiropractic Care one session

Chiropractic care (more than one visit) OTHER

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

Also known as: Chiropractic Tx2

Group Chiropractic Care multiple sessions

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• chiropractic patients active when lockdown was declared, over the age of 14

You may not qualify if:

• new patients in the clinic, patients with no current pain at the time of the trial

Sponsors & Collaborators

• Real Centro Universitario Maria Cristina: lead
• Université du Québec à Trois-Rivières: collaborator
• University of Birmingham: collaborator

Study Sites (1)

Real Centro Universitario María Cristina

El Escorial, Madrid, 28200, Spain

Location

MeSH Terms

Conditions

Musculoskeletal Pain

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Arantxa Ortega de Mues, PhD

  Madrid College of Chiropractic - Real Centro Universitario Maria Cristina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Care was provided by chiropractors,
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 29, 2020
• First Posted: October 5, 2020
• Study Start: May 2, 2020
• Primary Completion: May 27, 2020
• Study Completion: May 27, 2020
• Last Updated: October 5, 2020

Record last verified: 2020-09

Locations

ES (1)