NCT04394169: PAIN-COVID

Early Care Program for the Management of Post-ICU Syndrome and Chronic Pain After COVID-19 Infection.

Completed NA Last updated 14 December 2021

What this trial tests

NA trial testing Intervention program in Post ICU Syndrome in 102 participants. Completed in 22 October 2021.

Timeline

25 May 2020

Primary endpoint
15 October 2021

22 October 2021

Quick facts

Lead sponsor	Hospital Clinic of Barcelona
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	102
Start date	25 May 2020
Primary completion	15 October 2021
Estimated completion	22 October 2021
Sites	1 location across Spain

Drugs / interventions tested

• Intervention program

Conditions studied

• Post ICU Syndrome — all drugs for Post ICU Syndrome →
• Chronic Pain — all drugs for Chronic Pain →
• Covid-19 — all drugs for Covid-19 →

Sponsor

Hospital Clinic of Barcelona

Who can join

18 and older, any sex, with Post ICU Syndrome or Chronic Pain. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

COVID-19 (coronavirus 2019) disease has led to a large number of hospital admissions, many of which require admission to intensive care (ICU).

Post-intensive care syndrome (PICS) is defined as deterioration or worsening of previous deterioration in the mental, physical or cognitive status that appears as a consequence of a critical illness and which persists after acute hospital care. Also, there is evidence that patients who survive a critical illness have a high prevalence of moderate to extreme chronic pain.

Patients with COVID-19 disease are an especially susceptible population to develop PICS due to acute respiratory distress syndrome (ARDS) survivors have significant long-term deterioration in mental, cognitive, and functional health.

This study hypothesis is that a specific care program based on early therapeutic education and psychological intervention improves the quality of life of patients at risk of developing PICS and chronic pain after COVID-19 disease.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Characteristics and influence on quality of life of new-onset pain in critical COVID-19 survivors.
   Ojeda A, Calvo A, Cuñat T, Mellado-Artigas R, et al · · 2022 · cited 29× · PMID 34866276 · DOI 10.1002/ejp.1897
2. Rationale and study design of an early care, therapeutic education, and psychological intervention program for the management of post-intensive care syndrome and chronic pain after COVID-19 infection (PAIN-COVID): study protocol for a randomized controlled trial.
   Ojeda A, Calvo A, Cuñat T, Artigas RM, et al · · 2021 · cited 11× · PMID 34303381 · DOI 10.1186/s13063-021-05463-7
3. SARS-Cov-2 Damage on the Nervous System and Mental Health.
   Boulkrane MS, Ilina V, Melchakov R, Arisov M, et al · · 2022 · cited 4× · PMID 34191699 · DOI 10.2174/1570159x19666210629151303
4. Effectiveness of a specific follow up program for the management of the mental components of post-intensive care syndrome and chronic pain after COVID-19: results from the PAIN-COVID randomized clinical trial.
   Ojeda A, Calvo A, Cuñat T, Mellado-Artigas R, et al · · 2024 · cited 3× · PMID 38242358 · DOI 10.1016/j.redare.2023.12.009
5. New-onset chronic and neuropathic pain in survivors of severe COVID-19: A secondary analysis of the PAIN-COVID Trial.
   Ojeda A, Cuñat T, Comino-Trinidad O, Aliaga J, et al · · 2025 · PMID 40998165 · DOI 10.1016/j.redare.2025.501915
6. Rationale and Study Design of an Early Care, Therapeutic Education, and Psychological Intervention for the Management of Post-intensive Care Syndrome and Chronic Pain After Coronavirus Disease 2019 (PAIN-COVID): Study protocol for a randomized controlled trial
   Ojeda A, Calvo A, Cuñat T, Artigas RM, et al · · 2021 · DOI 10.21203/rs.3.rs-54199/v2
7. Incidence of New-Onset Pain, Characteristics and Influence on Health-Related Quality of life in COVID-19 Survivors After Critical Illness. Analysis of the PAIN COVID Clinical Trial cohort.
   Ojeda A, Calvo A, Cuñat T, Artigas RM, et al · · 2020 · DOI 10.21203/rs.3.rs-125421/v1