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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pain Neuroscience Education (PNE)+ Therapeutic Exercise (TE) | Experimental | Intervention Group (IG): 12-week program consisting of:
|
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| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pain Neuroscience Education (PNE)+ Therapeutic Exercise (TE) | Behavioral | 12-week program consisting of PNE and TE |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Intensity | Visual Analog Scale, VAS (0-100mm). | 3 months |
| Body Chart | Nordic Questionnaire | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidad de Valladolid | Valladolid | VALLADOLID | 47005 | Spain |
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| ID | Term |
|---|---|
| D000094024 | Post-Acute COVID-19 Syndrome |
| D010146 | Pain |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
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| Active Comparator: Usual treatment | Behavioral | 12-week program consisting of home exercises, performed 3 days/week. |
|
| 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 |
| D007239 |
| Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000094025 | Post-Infectious Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D001519 | Behavior |