Clinical trial NCT05894629: Effects of an Active Coping Program in Patients With Persistent Post-Covid Pain.
Official title: Effects of an Active Coping Program in Patients With Persistent Post-Covid Pain.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Long COVID
Pain
Keywords: Intervention
Long Covid Pain
Pain Neuroscience Education
Exercise
Lead sponsor: University of Valladolid
Sponsor class: OTHER
First posted: 2023-06-08
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Quality of life (QoL)
timeFrame: 3 months
Secondary outcomes:
measure: Pain Intensity
timeFrame: 3 months
measure: Body Chart
timeFrame: 3 months
measure: Quantitative sensory tests
timeFrame: 3 months
measure: Handgrip Strength assessment
timeFrame: 3 months
measure: 30 sit to stand test
timeFrame: 3 months
measure: 6 Minute Walking Test (6MWT)
timeFrame: 3 months
measure: Maximal Inspiratory and Expiration Pressure (MIP/MEP)
timeFrame: 3 months
measure: Catastrophism
timeFrame: 3 months
measure: Anxiety
timeFrame: 3 months
measure: Depression
timeFrame: 3 months
measure: Drug consumption.
timeFrame: 3 months
measure: Fatigue
timeFrame: 3 months
Other outcomes:
Locations:
city: Valladolid
country: Spain
facility: Universidad de Valladolid
Study officials:
References: