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OpenTrials
Completed

NCT Number: NCT05894629

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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad de Valladolid

Valladolid, VALLADOLID, 47005, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Behavioral

12-week program consisting of PNE and TE

Active Comparator: Usual treatment

Behavioral

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

Primary outcomes

  1. Quality of life (QoL)

    Time frame: 3 months

    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).

Secondary outcomes

  1. Pain Intensity

    Time frame: 3 months

    Visual Analog Scale, VAS (0-100mm).

  2. Body Chart

    Time frame: 3 months

    Nordic Questionnaire

  3. Quantitative sensory tests

    Time frame: 3 months

    pain detection to pressure

  4. Handgrip Strength assessment

    Time frame: 3 months

    With a manual dynamometer.

  5. 30 sit to stand test

    Time frame: 3 months

  6. 6 Minute Walking Test (6MWT)

    Time frame: 3 months

  7. Maximal Inspiratory and Expiration Pressure (MIP/MEP)

    Time frame: 3 months

  8. Catastrophism

    Time frame: 3 months

    Pain Catastrophism Scale (ECD).

  9. Anxiety

    Time frame: 3 months

    Beck Anxiety Questionnaire (BAI)

  10. Depression

    Time frame: 3 months

    Beck Depression Questionnaire-II (BDI-II)

  11. Drug consumption.

    Time frame: 3 months

    Record by dose of the consumption of drugs for the patient's pain pre-post intervention.

  12. Fatigue

    Time frame: 3 months

    Modified Fatigue Impact Scale (MFIS)

Sponsors and collaborators

Lead sponsor

University of Valladolid

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jun 8, 2023
Registry last updated
Jun 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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