Physiotherapy in Post COVID-19 Syndrome Patients
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Cognitive behavioral principles-based treatment program group
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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.
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| Active Comparator: Control group
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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.
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Outcome Measures
Primary Outcome Measures
- Fear-avoidance belief changes [Baseline]
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).
- Fear-avoidance belief changes [At 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
- Changes in functionality [Baseline]
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 functionality [At 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 catastrophizing [Baseline]
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 pain catastrophizing [At 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 pain interference [Baseline]
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.
- Changes in pain interference [At 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.
- Changes in the sensory, affective and evaluative dimensions of pain. [Baseline]
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 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients of both sexes.
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Agreed to participate.
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Post COVID-19 patients meeting the WHO definition for this disease.
Exclusion Criteria:
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Neurological or orthopaedic pathologies that limited voluntary movement.
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Cognitive impairment that prevented them from understanding and answering the questionnaires.
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Patients suffering from a reinfection with SARS-CoV-2.
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Patients who had been hospitalized due to COVID-19 infection.
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Patients who had pre-existing chronic pain according to the current IASP definition.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Faculty of Health Sciences. University of Granada. | Granada. | Granada | Spain | 18071 |
Sponsors and Collaborators
- Universidad de Granada
Investigators
- Principal Investigator: Marie Carmen Valenza, PhD, Universidad de Granada
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- DF0098UG