Physiotherapy in Post COVID-19 Syndrome Patients

Cognitive Behavioral Principles-based Treatment Program for Patients With Post COVID-19 Syndrome

Patients who have undergone COVID-19 infection often have long-term sequelae. One of the most prevalent sequelae is pain. The main objective of this research is to investigate the efficacy of a cognitive behavioral principles-based treatment program in fear avoidance beliefs, disability, pain catastrophizing and pain interference.

Study Overview

• Status: Completed
• Conditions: Post-COVID-19 Syndrome
• Intervention / Treatment: Other: Cognitive behavioral principles-based treatment program; Other: Control intervention

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Granada
    • Granada., Granada, Spain, 18071
      • Faculty of Health Sciences. University of Granada.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients of both sexes.
• Agreed to participate.
• Post COVID-19 patients meeting the WHO definition for this disease.

Exclusion Criteria:

• Neurological or orthopaedic pathologies that limited voluntary movement.
• Cognitive impairment that prevented them from understanding and answering the questionnaires.
• Patients suffering from a reinfection with SARS-CoV-2.
• Patients who had been hospitalized due to COVID-19 infection.
• Patients who had pre-existing chronic pain according to the current IASP definition.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group	Other: Control intervention; Patients received an informational brochure in a consultation with a health professional. The brochure explained the importance of physical activity to improve the health condition of these patients. Patients had the opportunity to ask any questions to the healthcare professional.
Experimental: Cognitive behavioral principles-based treatment program group	Other: Cognitive behavioral principles-based treatment program; The treatment protocol had a total duration of 6 weeks. Two sessions were conducted each week, the first being a group session lasting 1.5 hours and the second an individual session lasting 45 minutes. During the group sessions, emotional disclosure and sharing of the experiences of patients with post COVID-19 syndrome were encouraged. During the individual sessions, a strong relationship was developed between the patient and the healthcare professional, with the healthcare professional helping the patient develop self-efficacy, thought monitoring, helpful self-talk, and reflection on changes in activity levels throughout the program.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fear-avoidance belief changes	Fear avoidance beliefs will be assessed by the the Fear Avoidance Beliefs Questionnaire (FABQ). It consists of 16 sentences related to physical activity (first 5 items) and work (last 11 items).	Baseline
Fear-avoidance belief changes	Fear avoidance beliefs will be assessed by the the Fear Avoidance Beliefs Questionnaire (FABQ). It consists of 16 sentences related to physical activity (first 5 items) and work (last 11 items).	At 6 weeks at the end of the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in functionality	Changes in functionality were measured using the World Health Organization Disability Assessment Schedule, WHODAS-2, which provides a global measure of disability and 7 domain-specific scores.	Baseline
Changes in functionality	Changes in functionality were measured using the World Health Organization Disability Assessment Schedule, WHODAS-2, which provides a global measure of disability and 7 domain-specific scores.	At 6 weeks at the end of the intervention
Changes in pain catastrophizing	Changes in pain catastrophizing were assessed with the pain catastrophizing scale. It consists of a 13-item scale with values from 0 to 4. The higher the score, the greater the pain catastrophization.	Baseline
Changes in pain catastrophizing	Changes in pain catastrophizing were assessed with the pain catastrophizing scale. It consists of a 13-item scale with values from 0 to 4. The higher the score, the greater the pain catastrophization.	At 6 weeks at the end of the intervention
Changes in pain interference	In the PROMIS PI, item category responses range from 1 to 5. T scores had a mean score of 50 and a standard deviation of 10 points. Low scores on the PROMIS PI represent less interference of pain with physical function, whereas high scores represent greater interference with physical function.	Baseline
Changes in pain interference	In the PROMIS PI, item category responses range from 1 to 5. T scores had a mean score of 50 and a standard deviation of 10 points. Low scores on the PROMIS PI represent less interference of pain with physical function, whereas high scores represent greater interference with physical function.	At 6 weeks at the end of the intervention
Changes in the sensory, affective and evaluative dimensions of pain.	The Short Form McGuill Pain Questionnaire (SF-MPQ) is a version of the original McGuill Pain Questionnaire, discovered by Melzak in 1987. This scale is divided into several parts. The first part consists of a list of 15 adjectives, including 11 sensory and 4 affective descriptors of pain (e.g., terrible, throbbing, etc.) on a scale ranging from 0 (none) to 3 (severe), giving an overall score ranging from 0 to 45, as well as two scores from 0 to 33 for the sensory subscale and 0 to 12 for the affective subscale. In addition, it includes a VAS scale that assesses the patient's pain in the last week. Finally, it includes a Present Pain Intensity Scale (PPI). The PPI is based on a single item measuring overall pain intensity. Patients are asked about their current level of pain on a 5-point Likert scale ranging from 0 (no pain) to 5 (unbearable). This scale has been shown to have excellent psychometric properties.	Baseline
Changes in the sensory, affective and evaluative dimensions of pain.	The Short Form McGuill Pain Questionnaire (SF-MPQ) is a version of the original McGuill Pain Questionnaire, discovered by Melzak in 1987. This scale is divided into several parts. The first part consists of a list of 15 adjectives, including 11 sensory and 4 affective descriptors of pain (e.g., terrible, throbbing, etc.) on a scale ranging from 0 (none) to 3 (severe), giving an overall score ranging from 0 to 45, as well as two scores from 0 to 33 for the sensory subscale and 0 to 12 for the affective subscale. In addition, it includes a VAS scale that assesses the patient's pain in the last week. Finally, it includes a Present Pain Intensity Scale (PPI). The PPI is based on a single item measuring overall pain intensity. Patients are asked about their current level of pain on a 5-point Likert scale ranging from 0 (no pain) to 5 (unbearable). This scale has been shown to have excellent psychometric properties.	At 6 weeks at the end of the intervention

Collaborators and Investigators

• Sponsor: Universidad de Granada
• Investigators: Principal Investigator: Marie Carmen Valenza, PhD, Universidad de Granada

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Actual): September 15, 2022
• Study Completion (Actual): September 22, 2022

Study Registration Dates

• First Submitted: July 26, 2022
• First Submitted That Met QC Criteria: July 26, 2022
• First Posted (Actual): July 28, 2022

Study Record Updates

• Last Update Posted (Actual): November 27, 2023
• Last Update Submitted That Met QC Criteria: November 24, 2023
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease; COVID-19; Syndrome
• Other Study ID Numbers: DF0098UG

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No