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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05894629
• Other study ID #: LGCOVIDTRIAL
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 20, 2023
• Est. completion date: September 30, 2023

Study information

• Verified date: June 2023
• Source: University of Valladolid
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 89
• Est. completion date: September 30, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Long COVID
• Pain

Intervention

Behavioral:
• Pain Neuroscience Education (PNE)+ Therapeutic Exercise (TE)
12-week program consisting of PNE and TE
• Active Comparator: Usual treatment
12-week program consisting of home exercises, performed 3 days/week.

Locations

Country	Name	City	State
Spain	Universidad de Valladolid	Valladolid

Sponsors (1)

Lead Sponsor	Collaborator
University of Valladolid

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pain Intensity	Visual Analog Scale, VAS (0-100mm).	3 months
Secondary	Body Chart	Nordic Questionnaire	3 months
Secondary	Quantitative sensory tests	pain detection to pressure	3 months
Secondary	Handgrip Strength assessment	With a manual dynamometer.	3 months
Secondary	30 sit to stand test		3 months
Secondary	6 Minute Walking Test (6MWT)		3 months
Secondary	Maximal Inspiratory and Expiration Pressure (MIP/MEP)		3 months