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Completed

NCT Number: NCT04573361

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

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.

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Key information

Conditions

Musculoskeletal Pain Disability Physical Muscular Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Psychological Distress Signs and Symptoms

Age range

14 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Real Centro Universitario María Cristina

El Escorial, Madrid, 28200, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: Chiropractic Tx1

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

Other names: Chiropractic Tx2

Primary outcomes

  1. Pain intensity

    Time frame: 14 days

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

  2. Pain frequency

    Time frame: 14 days

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

  3. Pain evolution

    Time frame: 14 days

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

  4. Pain interference

    Time frame: 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 outcomes

  1. Pain Catastrophizing Scale

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 14 days

    Questionnaire, subscale 10 items, Likert scale from 1 to 4, lowest score (1) WORST outcomes, highest score (40) BETTER outcomes

Sponsors and collaborators

Lead sponsor

Real Centro Universitario Maria Cristina

Other

Collaborators

  • University of Birmingham
  • Université du Québec à Trois-Rivières

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Oct 5, 2020
Registry last updated
Oct 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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