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

NCT05475743 | Completed

• 1 other identifier: DF0097UG
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• Changes in pain intensity and pain interference

  Pain intensity and interference were quantified using the Brief Pain Inventory (BPI). The section intended to measure pain intensity on the BPI comprises four items, while the section related to pain interference includes seven items. In the intensity section, responses range on a scale from 0 (no pain) to 10 (maximum pain), while in the interference section, responses range from 0 (no interference) to 10 (total interference). To calculate the severity and interference index, the values of the corresponding items are averaged, obtaining values ranging from 0 to 10, with a higher score indicating greater pain intensity and interference. The BPI has been validated as a reliable and valid tool to evaluate these aspects of pain.

  Baseline and at 8 weeks at the end of the intervention

• Changes in catastrophization

  To evaluate the phenomenon of catastrophizing, the Pain Catastrophizing Scale (PCS) was applied. This instrument consists of 13 statements structured on a 5-point Likert scale ranging from 0 (at no time) to 4 (at all times). The PCS breaks down catastrophizing into three components: feelings of helplessness, magnification of difficulties, and rumination about pain. Each of the items describes different thoughts and emotions that people may experience when in pain. The final score is obtained by summing the scores of all the items, resulting in a score ranging from 0 to 52, with higher scores indicating a higher level of catastrophizing.

  Baseline and at 8 weeks at the end of the intervention

• Changes in kinesiophobia

  The Tampa Kinesiophobia Scale (TSK) was used to quantify apprehension related to physical activity and the fear of injury (or re-injury). This scale is composed of 11 statements, which are assigned a score on a 4-point scale (1-4). Total scores vary between 11 and 44 points, with higher values being indicative of greater fear of movement and the possibility of (re)injury.

  Baseline and at 8 weeks at the end of the intervention

• Changes in functionality

  Functionality was assessed using the WHODAS 2.0 tool (World Health Organization Disability Assessment Schedule). It consists in 36 items assessing six main areas of functional ability. This questionnaire uses a 5-point Likert scale for respondents to rate their level of difficulty in six main subscales: Cognition, Mobility, Self-Care, Interpersonal Relationships, Home Life and Community Involvement. Response options go from 1 (no difficulty) to 5 (extreme difficulty or can not do). The scores obtained in each area are added to obtain a total score that shows the degree of functional limitation.

  Baseline and at 8 weeks at the end of the intervention

Study Arms (2)

Pain Informed Movement program

EXPERIMENTAL

Other: Pain Informed Movement program

Standard medical care and leaflet education

ACTIVE COMPARATOR

Other: Standard medical care and leaflet education

Interventions

Pain Informed Movement program 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.

Pain Informed Movement program

Standard medical care and leaflet education 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.

Standard medical care and leaflet education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de Granada: lead

Study Sites (1)

Faculty of Health Sciences. University of Granada.

Granada, Granada, 18071, Spain

Location

Study Officials

• Marie Carmen Valenza, PhD

  Universidad de Granada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 26, 2022
• First Posted: July 27, 2022
• Study Start: August 1, 2023
• Primary Completion: October 1, 2023
• Study Completion: October 7, 2023
• Last Updated: February 12, 2024

Record last verified: 2024-02

Locations

ES (1)