## Protocol Section
### Identification Module
**NCT ID:** NCT04666779

**Brief Title:** Access to Chiropractic Care During the COVID-19 Pandemic

**Official Title:** Access to Chiropractic Care During the COVID-19 Pandemic: a Prospective Comparative Cohort Trial

#### Organization Study ID Info
**ID:** CohortChiroCOVID19
#### Organization
**Class:** OTHER
**Full Name:** Real Centro Universitario Maria Cristina
### Status Module
#### Completion Date
**Date:** 2021-09-15

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2021-09-16

**Type:** ACTUAL

**Last Update Submit Date:** 2021-09-14

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2021-02-21

**Type:** ACTUAL

#### Start Date
**Date:** 2020-12-18

**Type:** ACTUAL

**Status Verified Date:** 2021-09

#### Study First Post Date
**Date:** 2020-12-14
**Type:** ACTUAL
**Study First Submit Date:** 2020-12-11
**Study First Submit QC Date:** 2020-12-11
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** University of Birmingham

**Class:** OTHER

**Name:** Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

**Class:** OTHER

**Name:** Université du Québec à Trois-Rivières

#### Lead Sponsor

**Class:** OTHER

**Name:** Real Centro Universitario Maria Cristina

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** This is a prospective comparative cohort trial taking place during the first year of the Coronavirus-19 (COVID-19) pandemic in Spain. Chiropractic patients throughout Spain were invited to participate independently of the care received, including patients who had stopped visiting their chiropractors since the pandemic hit. The main exposure variable is the access to chiropractic care services, and the degree of this exposure during the months following initial lockdown phase in Spain. Participants will fill an online questionnaire with self-reported outcome-measures.

### Conditions Module

**Conditions:**

- Access to Chiropractic Care Services

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 399

**Type:** ACTUAL

**Patient Registry:** True

**Study Type:** OBSERVATIONAL

**Target Duration:** 6 Months

### Arms Interventions Module

#### Arm Group 1

**Description:** Group not accessing chiropractic care

**Label:** No access

#### Arm Group 2

**Description:** Group with access to care in a 6 months period. Differences in the degree of access, measured in ranges of numbers of visits, will be used as independent variable within this group.

**Intervention Names:**

- Other: Chiropractic care

**Label:** Access to care

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Access to care

**Description:** Care provided by chiropractors, based on manual therapy, exercise prescription and patient advice/education/reassurance

**Name:** Chiropractic care

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Numerical Rating Scale (0-10, 0=no pain, 10=maximum pain)

**Measure:** Pain intensity

**Time Frame:** 6 months

**Description:** Duration of pain symptoms, PREVIOUS to the study, measured in months (up to 3 months, more than 3 months)

**Measure:** Pain duration

**Time Frame:** 6 months

**Description:** Ranges: Constant, every day, every week, occasionally

**Measure:** Pain frequency

**Time Frame:** 6 months

**Description:** Categories: New pain, worsened, no change, improv, gone

**Measure:** Pain perceived improvement

**Time Frame:** 6 months

**Description:** From the Brief Pain Inventory (7 items, 0-10: 0= minimal score, 70=maximal score)

**Measure:** Pain interference

**Time Frame:** 6 months

**Description:** Validated questionnaire (short version 4 items, 1-4: 4= minimal score, 16=maximal score)

**Measure:** Pain Catastrophizing Scale

**Time Frame:** 6 months

**Description:** Validated questionnaire (short version 11 items, 0-3: 0=minimal score, 33=maximal score)

**Measure:** Tampa Scale Kinesiophobia

**Time Frame:** 6 months

#### Secondary Outcomes

**Description:** Validated questionnaire (7 items , 1-3: 1= minimal score, 21=maximal score)

**Measure:** General Anxiety Disorder scale

**Time Frame:** 6 months

**Description:** Questionnaire (12 items, 1-4: 1=minimal score, 48=maximal score)

**Measure:** Fear of Illness and Virus Evaluation

**Time Frame:** 6 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* chiropractic patients with pain, active when lockdown was declared, over the age of 16

Exclusion Criteria:

* new patients in the clinic after the pandemic hit

**Minimum Age:** 16 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

**Study Population:** Chiropractic patients when the pandemic hit in Spain (March 2020), who consulted a chiropractor for pain as one of the chief complaints (not necessarily the main or the only one)

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** San Lorenzo De El Escorial

**Country:** Spain

**Facility:** Real Centro Universitario María Cristina

**State:** Madrid

**Zip:** 28200

#### Overall Officials

**Official 1:**

**Affiliation:** Real Centro Universitario María Cristina

**Name:** Arantxa Ortega de Mues, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**Description:** All collected IPD will be shared, the format is yet to be decided.

**IPD Sharing:** UNDECIDED

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000011024

- Term: Pneumonia, Viral

- ID: D000011014

- Term: Pneumonia

- ID: D000012141

- Term: Respiratory Tract Infections

- ID: D000007239

- Term: Infections

- ID: D000014777

- Term: Virus Diseases

- ID: D000018352

- Term: Coronavirus Infections

- ID: D000003333

- Term: Coronaviridae Infections

- ID: D000030341

- Term: Nidovirales Infections

- ID: D000012327

- Term: RNA Virus Infections

- ID: D000008171

- Term: Lung Diseases

- ID: D000012140

- Term: Respiratory Tract Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M2561

- Name: COVID-19

- Relevance: HIGH

- As Found: COVID-19 Pandemic

- ID: M13904

- Name: Pneumonia

- Relevance: LOW

- As Found: Unknown

- ID: M13914

- Name: Pneumonia, Viral

- Relevance: LOW

- As Found: Unknown

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14978

- Name: Respiratory Tract Infections

- Relevance: LOW

- As Found: Unknown

- ID: M17522

- Name: Virus Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M20490

- Name: Coronavirus Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6555

- Name: Coronaviridae Infections

- Relevance: LOW

- As Found: Unknown

- ID: M23685

- Name: Nidovirales Infections

- Relevance: LOW

- As Found: Unknown

- ID: M15149

- Name: RNA Virus Infections

- Relevance: LOW

- As Found: Unknown

- ID: M11168

- Name: Lung Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000086382

- Term: COVID-19

### Misc Info Module

- Version Holder: 2024-05-24
