Effects of an Active Coping Program in Patients With Persistent Post-Covid Pain.

Justification: among the sequelae of Covid-19 in clinical practice we frequently find persistent neuromusculoskeletal pain. Previous studies carried out by this research group and in the scientific literature have shown that "Pain Neuroscience Education" (PNE) and Therapeutic Exercise (TE) constitute an effective care strategy in the treatment of persistent pain. Therefore, with this research we will try to respond with a treatment proposal from Primary Care (PC).

Objective: to determine whether an PNE and TE program is effective in patients presenting Long Covid Pain (LCP).

Method: Randomized clinical trial. A sample of 80 subjects will be recruited. The intervention group will receive a program of TE and PNE, of 12 weeks duration: 5 weeks of PNE, of 1 weekly session of 90 minutes, and 7 weeks of TE, with a total of 19 sessions of 60 minutes duration. The control group will receive the usual treatment. An assessment will be made at the beginning and after the end of the intervention, where the following variables will be measured: quality of life, intensity, distribution and expansion of pain, healthy physical condition and blood test values. These will be evaluated by means of physical examination, questionnaires and laboratory tests.

Applicability of the expected results: The proposed intervention is simple and reproducible. It requires few resources, and can produce changes in pain perception, functionality and quality of life in patients with LCP.

Study Overview

• Status: Completed
• Conditions: Pain; Long COVID
• Intervention / Treatment: Behavioral: Pain Neuroscience Education (PNE)+ Therapeutic Exercise (TE); Behavioral: Active Comparator: Usual treatment

• Study Type: Interventional
• Enrollment (Actual): 89
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Valladolid, Spain, 47005
    • Universidad de Valladolid

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients who have had Covid-19, with a confirmatory PCR+ test or positive antigen test and recorded in their primary care medical record.
• Subjects between 18-70 years old.
• Musculoskeletal pain of more than 12 weeks of evolution since the beginning of the infection.
• Agree to participate in the study and sign the informed consent form.

Exclusion Criteria:

• History of chronic musculoskeletal pain of more than 12 weeks of evolution prior to Covid-19.
• History of diagnosed major depression.
• Having a diagnosis of fibromyalgia prior to Covid-19 infection.
• Pregnancy.
• Pain of oncologic origin.
• Fracture or surgical intervention on the spine in the last year.
• Cognitive neurological impairment that prevents understanding of PNE contents (in case of doubt, assessment with Minimental state examination).
• Bladder or bowel incontinence.
• Saddle anesthesia.
• Patients with other clinical conditions that may aggravate chronic spine pain (chronic fatigue syndrome, fibromyalgia and complex regional pain syndrome).
• Patients with associated pathologies that make it impossible for them to perform TE.
• Patients undergoing treatment with alternative therapies.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pain Neuroscience Education (PNE)+ Therapeutic Exercise (TE); Intervention Group (IG): 12-week program consisting of: 6 PNE sessions (1 session of 90 minutes per week for 5 weeks).; 19 sessions of TE (2-3 weekly sessions of 60 minutes, for 7 weeks).	Behavioral: Pain Neuroscience Education (PNE)+ Therapeutic Exercise (TE); 12-week program consisting of PNE and TE
Active Comparator: Usual treatment; Delivery of a printed document with exercises to be performed at home for patients with persistent pain endorsed by a Scientific Society, as has been done in the Spanish Health Care Public System's usual practice with patients with chronic pain.	Behavioral: Active Comparator: Usual treatment; 12-week program consisting of home exercises, performed 3 days/week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life (QoL)	EQ-5D questionnaire (Quality of life 5 dimension questionnaire): The EQ-5D is a brief multi-attribute health status measure composed of five questions with Likert response options (descriptive system) and a visual analogue scale (EQ-VAS). The descriptive system covers five dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) with three levels of severity in each dimension (no problems, some problems, and extreme problems).	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Intensity	Visual Analog Scale, VAS (0-100mm).	3 months
Body Chart	Nordic Questionnaire	3 months
Quantitative sensory tests	pain detection to pressure	3 months
Handgrip Strength assessment	With a manual dynamometer.	3 months
30 sit to stand test		3 months
6 Minute Walking Test (6MWT)		3 months
Maximal Inspiratory and Expiration Pressure (MIP/MEP)		3 months
Catastrophism	Pain Catastrophism Scale (ECD).	3 months
Anxiety	Beck Anxiety Questionnaire (BAI)	3 months
Depression	Beck Depression Questionnaire-II (BDI-II)	3 months
Drug consumption.	Record by dose of the consumption of drugs for the patient's pain pre-post intervention.	3 months
Fatigue	Modified Fatigue Impact Scale (MFIS)	3 months

Collaborators and Investigators

• Sponsor: University of Valladolid

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2023
• Primary Completion (Actual): June 1, 2023
• Study Completion (Actual): September 30, 2023

Study Registration Dates

• First Submitted: June 6, 2023
• First Submitted That Met QC Criteria: June 7, 2023
• First Posted (Actual): June 8, 2023

Study Record Updates

• Last Update Posted (Actual): June 4, 2025
• Last Update Submitted That Met QC Criteria: May 29, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Exercise; Intervention; Pain Neuroscience Education; Long Covid Pain
• Additional Relevant MeSH Terms: Post-Infectious Disorders; COVID-19; Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; Post-Acute COVID-19 Syndrome
• Other Study ID Numbers: LGCOVIDTRIAL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No