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

Early Effects of a Pain Informed Movement Program in Patients With Post COVID-19 Condition Experiencing Persistent Pain: a Randomized Control Trial

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.

Study Overview

• Status: Completed
• Conditions: Post COVID-19 Condition
• Intervention / Treatment: Other: Pain Informed Movement program; Other: Standard medical care and leaflet education

• Study Type: Interventional
• Enrollment (Actual): 60
• 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 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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pain Informed Movement program	Other: 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.
Active Comparator: Standard medical care and leaflet education	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in activity levels	Activity levels will be evaluated with the International Physical Activity Questionnaire. It assess the frequency and time spent on vigorous, moderate-intensity activities and walking time for each category. Higher values indicate higher activity levels.	Baseline
Change in activity levels	Activity levels will be evaluated with the International Physical Activity Questionnaire. It assess the frequency and time spent on vigorous, moderate-intensity activities and walking time for each category. Higher values indicate higher activity levels.	At 6 weeks at the end of the intervention
Changes in pain knowledge	The Neurophysiology of Pain Questionnaire was used to assess pain knowledge. It consists of 19 items with a false, true or undecided response option. For each correct answer a point is added, the maximum score being 19. The higher the score, the greater the knowledge of pain. The questions refer to the biological mechanisms of pain or how and why pain is perceived.	Baseline
Changes in pain knowledge	The Neurophysiology of Pain Questionnaire was used to assess pain knowledge. It consists of 19 items with a false, true or undecided response option. For each correct answer a point is added, the maximum score being 19. The higher the score, the greater the knowledge of pain. The questions refer to the biological mechanisms of pain or how and why pain is perceived.	At 6 weeks at the end of the intervention
Changes in perceived health status	The PROMIS-29 questionnaire is divided into seven core domains (physical function, pain interference, anxiety, depression, fatigue, sleep disturbance, and ability to participate in social roles and activities) and a separate item on pain intensity. Each of the items has 5 response options except the pain intensity item which have a numerical rating scale from 0 to 10. Total scores for each domain are expressed as T-scores with a mean of 50 and a standard deviation of 10 for the U.S. reference population. Higher T-scores indicate a higher level of the underlying construct.	Baseline
Changes in perceived health status	The PROMIS-29 questionnaire is divided into seven core domains (physical function, pain interference, anxiety, depression, fatigue, sleep disturbance, and ability to participate in social roles and activities) and a separate item on pain intensity. Each of the items has 5 response options except the pain intensity item which have a numerical rating scale from 0 to 10. Total scores for each domain are expressed as T-scores with a mean of 50 and a standard deviation of 10 for the U.S. reference population. Higher T-scores indicate a higher level of the underlying construct.	At 6 weeks at the end of the intervention
Changes in pain intensity and pain interference	Pain intensity and interference were measured with the Brief Pain Inventory (BPI). The pain intensity section of the BPI is composed of four items and the pain interference section is composed of seven items. For the intensity section the responses range from 0 (no pain) to 10 (worst pain) and for the interference section the responses range from 0 (no interference) to 10 (total interference). To obtain the severity and interference index, the mean of the corresponding items is calculated, obtaining values between 0 and 10, with a higher score reflecting greater pain intensity and interference. The BPI has been established as a reliable and valid tool for assessing pain severity and interference.	Baseline
Changes in pain intensity and pain interference	Pain intensity and interference were measured with the Brief Pain Inventory (BPI). The pain intensity section of the BPI is composed of four items and the pain interference section is composed of seven items. For the intensity section the responses range from 0 (no pain) to 10 (worst pain) and for the interference section the responses range from 0 (no interference) to 10 (total interference). To obtain the severity and interference index, the mean of the corresponding items is calculated, obtaining values between 0 and 10, with a higher score reflecting greater pain intensity and interference. The BPI has been established as a reliable and valid tool for assessing pain severity and interference.	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, 2023
• Primary Completion (Actual): October 1, 2023
• Study Completion (Actual): October 7, 2023

Study Registration Dates

• First Submitted: July 26, 2022
• First Submitted That Met QC Criteria: July 26, 2022
• First Posted (Actual): July 27, 2022

Study Record Updates

• Last Update Posted (Actual): February 12, 2024
• Last Update Submitted That Met QC Criteria: February 9, 2024
• Last Verified: February 1, 2024

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; COVID-19; Disease
• Other Study ID Numbers: DF0097UG

Drug and device information, study documents

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