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

Not Applicable

Active, not recruiting

• Conditions: Pain; Long COVID
• Interventions: Behavioral: Pain Neuroscience Education (PNE)+ Therapeutic Exercise (TE)

• Registration Number: NCT05894629
• Lead Sponsor: University of Valladolid

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-20
• Status Verified: 2023-06
• Primary Completion: 2023-06-01
• Study First Submitted: 2023-06-06
• Study First Submitted QC: 2023-06-07
• Last Update Submitted: 2023-06-07
• Study First Posted: 2023-06-08
• Last Update Posted: 2023-06-08
• Study Completion: 2023-09-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 89

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pain Neuroscience Education (PNE)+ Therapeutic Exercise (TE)	Pain Neuroscience Education (PNE)+ Therapeutic Exercise (TE)	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).

Primary Outcome Measures

Name	Time	Method
Quality of life (QoL)	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 Outcome Measures

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

Trial Locations

Locations (1)

Universidad de Valladolid; 🇪🇸 Valladolid, Spain