Pain Informed Movement Program in Patients With Post COVID-19 Condition

NCT ID: NCT05475743

Last Updated: 2024-02-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-01
• Study Completion Date: 2023-10-07

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 Pain Informed Movement program in patients with post COVID-19 condition experiencing persistent pain. Through the implementation of this program, the investigators seek to determine whether such intervention can offer significant improvements in reducing pain intensity and interference, catastrophizing, kinesiophobia, and functionality of affected patients.

Conditions

Post COVID-19 Condition

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Pain Informed Movement program

Group Type: EXPERIMENTAL

Pain Informed Movement program

Intervention Type: OTHER

The patients included in the experimental group attended an 8-week Pain Informed Movement program in addition to standard medical care. The program was led by a physical therapist with experience in treating patients with chronic pain. This program consisted of 2 face-to-face sessions per week, and they were asked to complete two sessions at home weekly. The first face-to-face session was a group session with 3-6 participants, and the second face-to-face session was individual. Both sessions lasted approximately 1 h. In the group sessions, pain neuroscience education was conducted. In the individual sessions, an individualized functional exercise program was performed by each patient, as well as relaxation techniques. Patients were asked to perform the functional exercises and relaxation techniques at home. Participants were asked to record their compliance with the program and their progress.

Standard medical care and leaflet education

Group Type: ACTIVE_COMPARATOR

Standard medical care and leaflet education

Intervention Type: OTHER

In addition to standard medical care, patients assigned to this group received a leaflet with information about the main post COVID-19 condition symptoms. This is a control group that was not controlled or monitored by a therapist.

Interventions

Pain Informed Movement program

The patients included in the experimental group attended an 8-week Pain Informed Movement program in addition to standard medical care. The program was led by a physical therapist with experience in treating patients with chronic pain. This program consisted of 2 face-to-face sessions per week, and they were asked to complete two sessions at home weekly. The first face-to-face session was a group session with 3-6 participants, and the second face-to-face session was individual. Both sessions lasted approximately 1 h. In the group sessions, pain neuroscience education was conducted. In the individual sessions, an individualized functional exercise program was performed by each patient, as well as relaxation techniques. Patients were asked to perform the functional exercises and relaxation techniques at home. Participants were asked to record their compliance with the program and their progress.

Intervention Type: OTHER

Standard medical care and leaflet education

In addition to standard medical care, patients assigned to this group received a leaflet with information about the main post COVID-19 condition symptoms. This is a control group that was not controlled or monitored by a therapist.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients of both sexes.
• Agreed to participate.
• Post COVID-19 condition patients meeting the WHO definition for this disease.
• Patients with moderate or severe pain were included, the cut-off point on the Visual Analogical Scale (VAS) being pain greater than or equal to 3.5 cm.

Exclusion Criteria

• Pulmonary, cardiac, neurological, vascular, or orthopaedic pathologies that could limit the execution of the evaluation and intervention.
• Cognitive impairment that prevented them from understanding and answering the questionnaires.
• Patients suffering from a reinfection with SARS-CoV-2.
• Patients with a history of severe or critical COVID-19 disease severity.
• Patients who had pre-existing chronic pain according to the current IASP definition.
• Patients participating in other studies.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad de Granada

OTHER

Sponsor Role: lead

Responsible Party

Marie Carmen Valenza

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marie Carmen Valenza, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidad de Granada

Locations

Faculty of Health Sciences. University of Granada.

Granada, Granada, Spain

Countries

Spain

Other Identifiers

DF0097UG

Identifier Type: -

Identifier Source: org_study_id