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Physiotherapy in Post COVID-19 Syndrome Patients

Not Applicable
Completed
Conditions
Post-COVID-19 Syndrome
Interventions
Other: Cognitive behavioral principles-based treatment program
Other: Control intervention
Registration Number
NCT05477199
Lead Sponsor
Universidad de Granada
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
54
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Cognitive behavioral principles-based treatment program groupCognitive behavioral principles-based treatment program-
Control groupControl intervention-
Primary Outcome Measures
NameTimeMethod
Fear-avoidance belief changesAt 6 weeks at the end of the intervention

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).

Secondary Outcome Measures
NameTimeMethod
Changes in pain catastrophizingAt 6 weeks at the end of the intervention

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.

Changes in the sensory, affective and evaluative dimensions of pain.At 6 weeks at the end of the intervention

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.

Changes in functionalityAt 6 weeks at the end of the intervention

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.

Changes in pain interferenceAt 6 weeks at the end of the intervention

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.

Trial Locations

Locations (1)

Faculty of Health Sciences. University of Granada.

🇪🇸

Granada., Granada, Spain

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