Long COVIDNCT05894629
Effects of an Active Coping Program in Patients With Persistent Post-Covid Pain.
A study testing Pain Neuroscience Education (PNE)+ Therapeutic Exercise (TE) and Active Comparator: Usual treatment in people with Long COVID and Pain, run by University of Valladolid at 1 site in Spain.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Long COVID, Pain
- What is being tested?
- Pain Neuroscience Education (PNE)+ Therapeutic Exercise (TE) and Active Comparator: Usual treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteSpain
- Study dates
- 20 Feb 2023to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read more
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.
- Conditions
- Long COVID, Pain
- Being tested
- Pain Neuroscience Education (PNE)+ Therapeutic Exercise (TE), Active Comparator: Usual treatment
- Keywords
- Intervention, Long Covid Pain, Pain Neuroscience Education, Exercise
- Medical subject headings
- Post-Acute COVID-19 Syndrome, Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain Neuroscience Education (PNE)+ Therapeutic Exercise (TE)Behavioural
12-week program consisting of PNE and TE
Active Comparator: Usual treatmentBehavioural
12-week program consisting of home exercises, performed 3 days/week.
| Study group | Role | What they receive |
|---|---|---|
| Pain Neuroscience Education (PNE)+ Therapeutic Exercise (TE) | Experimental | 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). Receives: Behavioral: Pain Neuroscience Education (PNE)+ Therapeutic Exercise (TE) |
| 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. Receives: Behavioral: Active Comparator: Usual treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 3 months
Secondary outcomes (12)
Pain Intensity
Visual Analog Scale, VAS (0-100mm).
Measured: 3 months
Body Chart
Nordic Questionnaire
Measured: 3 months
Quantitative sensory tests
pain detection to pressure
Measured: 3 months
Handgrip Strength assessment
With a manual dynamometer.
Measured: 3 months
30 sit to stand test
Measured: 3 months
6 Minute Walking Test (6MWT)
Measured: 3 months
Maximal Inspiratory and Expiration Pressure (MIP/MEP)
Measured: 3 months
Catastrophism
Pain Catastrophism Scale (ECD).
Measured: 3 months
Anxiety
Beck Anxiety Questionnaire (BAI)
Measured: 3 months
Depression
Beck Depression Questionnaire-II (BDI-II)
Measured: 3 months
Drug consumption.
Record by dose of the consumption of drugs for the patient's pain pre-post intervention.
Measured: 3 months
Fatigue
Modified Fatigue Impact Scale (MFIS)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2023
- Study start20 Feb 2023
- Primary completion1 Jun 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long COVIDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valladolid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura Barrero Santiago, University of Valladolid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05894629
- Sponsor's protocol ID
- LGCOVIDTRIAL
- Status last verified
- Apr 2025
- First submitted
- 6 Jun 2023
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an Active Coping Program in Patients With Persistent Post-Covid Pain.
- ClinicalTrials.gov ID
- NCT05894629
- Acronym / sponsor ID
- LGCOVIDTRIAL
- Conditions
- Long COVID, Pain
- Keywords
- Intervention, Long Covid Pain, Pain Neuroscience Education, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- University of ValladolidUniversity, hospital or other
- Study start
- 20 Feb 2023 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 8 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pain Neuroscience Education (PNE)+ Therapeutic Exercise (TE) | Experimental | Behavioral: 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). |
| Usual treatment | Active comparator | Behavioral: Active Comparator: Usual treatmentDelivery 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pain Neuroscience Education (PNE)+ Therapeutic Exercise (TE)12-week program consisting of PNE and TE | Behavioural | Pain Neuroscience Education (PNE)+ Therapeutic Exercise (TE) |
| Active Comparator: Usual treatment12-week program consisting of home exercises, performed 3 days/week. | Behavioural | Usual treatment |
Primary outcome
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).
12 secondary outcomes
Pain Intensity
Time frame: 3 months
Body Chart
Time frame: 3 months
Quantitative sensory tests
Time frame: 3 months
Handgrip Strength assessment
Time frame: 3 months
30 sit to stand test
Time frame: 3 months
6 Minute Walking Test (6MWT)
Time frame: 3 months
Maximal Inspiratory and Expiration Pressure (MIP/MEP)
Time frame: 3 months
Catastrophism
Time frame: 3 months
Anxiety
Time frame: 3 months
Depression
Time frame: 3 months
Drug consumption.
Time frame: 3 months
Fatigue
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pain Neuroscience Education (PNE)+ Therapeutic Exercise (TE) and Active Comparator: Usual treatment in people with Long COVID and Pain, run by University of Valladolid at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life (QoL) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2025.