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

NCT05894629 | Completed

• 1 other identifier: LGCOVIDTRIAL
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Long COVID; Pain

Keywords

Intervention; Long Covid Pain; Pain Neuroscience Education; Exercise

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Pain Intensity

  3 months

• Body Chart

  3 months

• Quantitative sensory tests

  3 months

• Handgrip Strength assessment

  3 months

• 30 sit to stand test

  3 months

Study Arms (2)

Pain Neuroscience Education (PNE)+ Therapeutic Exercise (TE)

EXPERIMENTAL

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)

Usual treatment

ACTIVE COMPARATOR

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

Interventions

Pain Neuroscience Education (PNE)+ Therapeutic Exercise (TE) BEHAVIORAL

12-week program consisting of PNE and TE

Pain Neuroscience Education (PNE)+ Therapeutic Exercise (TE)

Active Comparator: Usual treatment BEHAVIORAL

12-week program consisting of home exercises, performed 3 days/week.

Usual treatment

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Valladolid: lead

Study Sites (1)

Universidad de Valladolid

Valladolid, VALLADOLID, 47005, Spain

Location

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome; Pain; Motor Activity

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms; Behavior

Study Design

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

Study Record Dates

• First Submitted: June 6, 2023
• First Posted: June 8, 2023
• Study Start: February 20, 2023
• Primary Completion: June 1, 2023
• Study Completion: September 30, 2023
• Last Updated: June 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)