COVID-19NCT06723821
Noninvasive Neuromodulation in the Management of Post-COVID Musculoskeletal Pain
A study testing Neuromodulation group in people with COVID-19 and Musculoskeletal Pain, run by University of Alcala at 1 site in Spain.
Trial summary
Brief Summary: The post-Covid syndrome is a problem that affects a significant number of people in the world. Among the most common symptoms is pain, and although there is no specific data on neuropathic pain and Covid, due to under-diagnosis, they may be closely related. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- COVID-19, Musculoskeletal Pain
- What is being tested?
- Neuromodulation group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 15 Dec 2024to 15 Apr 2026
- 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
- Positive result in PCR or antigen test for detecting COVID-19 in the last 3 months.
- Present musculoskeletal pain in the last 3 months.
- Age between 18 to 65 years old.
- Score equal or superior to 4 in DN4 scale.
Who cannot join
- Present musculoskeletal pain of traumatic origin or known cause
- Present musculoskeletal pain with more than 3 months of evolution.
- Pregnant women
- Present of vascular alterations, malignancy, thrombophlebitis or fever.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Centro Investigación Fisioterapia y Dolor
Alcalá de Henares, Madrid, 28805
About this study
Official title: Effectiveness of Noninvasive Neuromodulation in Post-COVID Musculoskeletal Pain in the Short Term: Randomized Clinical Trial
Brief Summary:
The post-Covid syndrome is a problem that affects a significant number of people in the world. Among the most common symptoms is pain, and although there is no specific data on neuropathic pain and Covid, due to under-diagnosis, they may be closely related.
Read more
Non-invasive neuromodulation acts on the Central Nervous System through the bioelectrical stimulation of nervous tissue and modulation of the system nervous, and can be useful in acute, chronic and musculosqueletal pain, and in symptoms such as stress, anxiety and sleep disturbances.
The objective of this clinical trial is to assess the efficacy of non-invasive neuromodulation in the treatment of post-Covid musculoskeletal pain. Subjects will be randomly divided into two groups: an experimental group in which non-invasive neuromodulation will be applied and a sham group to which it will be applied off. The variables to be studied before, during and after treatment will be neuropathic pain with the DN4 questionnaire, pain intensity with the EVA scale, sleep quality with the Pittsburgh Sleep Quality Index, level of stress and anxiety with the HADS questionnaire and quality of life with the SF12.
- Conditions
- COVID-19, Musculoskeletal Pain
- Being tested
- Neuromodulation group, Neuromodulation sham group
- Medical subject headings
- COVID-19, Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuromodulation groupOther
During the 12 sessions of which the treatment consists in applying 60 minutes of microcurrent in low intensity.
Neuromodulation sham groupOther
During the 12 sessions of which the treatment consists in applying 60 minutes of sham microcurrent in low intensity.
| Study group | Role | What they receive |
|---|---|---|
| Neuromodulation experimental group | Experimental | The total number of sessions to be carried out on each patient will be 12 sessions, spread over 4 weeks.
The frequency will be 3 times a week. Each session with NESA microcurrents will last 60 minutes. Receives: Other: Neuromodulation group |
| Neuromodulation sham group | Sham comparator | The total number of sessions to be carried out on each patient will be 12 sessions, spread over 4 weeks.
The frequency will be 3 times a week. Each session with NESA microcurrents will last 60 minutes.The treatment will be applied with a placebo device that does not emit microcurrent but that has the same function Receives: Other: Neuromodulation sham group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale (VAS)
VAS is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured (symptom, pain, health), orientated from the left (worst) to the right (best)
Measured: Change from Baseline at one month.
Secondary outcomes (4)
DN4 scale
It is a clinician-administered questionnaire consisting of 10 items.Seven items related to pain quality (i.e. sensory and pain descriptors) are based on an interview with the patient. These components refer to how the pain feels to the patient Three items are based on the clinical examination. The clinician assesses whether there is reduced sensation (hyposthesia) to touch or pinprick and whether light brushing increases or causes pain (allodynia).The 7 symptoms items are scored by interviewing the patient, and the 3 remaining items are scored by means of clinical examination. The scores are added and a score of 4 or more out of 10 is suggestive of neuropathic pain.
Measured: Change from Baseline at one month.
Pittsburg Sleep Quality Index score
IThe Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality.The scores range from 0 to 21 and the authors suggest that a score >5 be considered as a significant sleep disturbance.
Measured: Change from Baseline at one month.
Hospital Anxiety and Depression Scale (HAND)
The HADS is a questionnaire widely used to evaluate anxiety and depression. A 14-item questionnaire to rate patient´s depression and anxiety. Each item has a 0-3 score indicating worse results with higher score
Measured: Change from Baseline at one month
Quality of life SF12
The SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. It is often used as a quality of life measure. A higher score is better outcome.
Measured: Change from Baseline at one month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start15 Dec 2024
- Primary completion15 Oct 2025
- Study completion15 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alcala
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Daniel Pecos Martín, University of Alcala
- Investigators
- Daniel Pecos-Martin, PhD, Study director, Alcala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06723821
- Sponsor's protocol ID
- CEIM/2022/6/121
- Status last verified
- Apr 2026
- First submitted
- 4 Dec 2024
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Noninvasive Neuromodulation in Post-COVID Musculoskeletal Pain in the Short Term: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06723821
- Acronym / sponsor ID
- CEIM/2022/6/121
- Conditions
- COVID-19, Musculoskeletal Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of AlcalaUniversity, hospital or other
- Study start
- 15 Dec 2024 (actual)
- Primary completion
- 15 Oct 2025 (actual)
- Study completion
- 15 Apr 2026 (actual)
- First posted
- 9 Dec 2024 (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.
Brief Summary:
The post-Covid syndrome is a problem that affects a significant number of people in the world. Among the most common symptoms is pain, and although there is no specific data on neuropathic pain and Covid, due to under-diagnosis, they may be closely related.
Non-invasive neuromodulation acts on the Central Nervous System through the bioelectrical stimulation of nervous tissue and modulation of the system nervous, and can be useful in acute, chronic and musculosqueletal pain, and in symptoms such as stress, anxiety and sleep disturbances.
The objective of this clinical trial is to assess the efficacy of non-invasive neuromodulation in the treatment of post-Covid musculoskeletal pain. Subjects will be randomly divided into two groups: an experimental group in which non-invasive neuromodulation will be applied and a sham group to which it will be applied off. The variables to be studied before, during and after treatment will be neuropathic pain with the DN4 questionnaire, pain intensity with the EVA scale, sleep quality with the Pittsburgh Sleep Quality Index, level of stress and anxiety with the HADS questionnaire and quality of life with the SF12.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neuromodulation experimental group | Experimental | Other: Neuromodulation groupThe total number of sessions to be carried out on each patient will be 12 sessions, spread over 4 weeks. The frequency will be 3 times a week. Each session with NESA microcurrents will last 60 minutes. |
| Neuromodulation sham group | Sham comparator | Other: Neuromodulation sham groupThe total number of sessions to be carried out on each patient will be 12 sessions, spread over 4 weeks. The frequency will be 3 times a week. Each session with NESA microcurrents will last 60 minutes.The treatment will be applied with a placebo device that does not emit microcurrent but that has the same function |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Positive result in PCR or antigen test for detecting COVID-19 in the last 3 months.
- Present musculoskeletal pain in the last 3 months.
- Age between 18 to 65 years old.
- Score equal or superior to 4 in DN4 scale.
Key exclusion criteria (4 listed)
- Present musculoskeletal pain of traumatic origin or known cause
- Present musculoskeletal pain with more than 3 months of evolution.
- Pregnant women
- Present of vascular alterations, malignancy, thrombophlebitis or fever.
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 |
|---|---|---|
| Neuromodulation groupDuring the 12 sessions of which the treatment consists in applying 60 minutes of microcurrent in low intensity. | Other | Neuromodulation experimental group |
| Neuromodulation sham groupDuring the 12 sessions of which the treatment consists in applying 60 minutes of sham microcurrent in low intensity. | Other | Neuromodulation sham group |
Primary outcome
Visual Analogue Scale (VAS)
Time frame: Change from Baseline at one month.
VAS is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured (symptom, pain, health), orientated from the left (worst) to the right (best)
4 secondary outcomes
DN4 scale
Time frame: Change from Baseline at one month.
Pittsburg Sleep Quality Index score
Time frame: Change from Baseline at one month.
Hospital Anxiety and Depression Scale (HAND)
Time frame: Change from Baseline at one month
Quality of life SF12
Time frame: Change from Baseline at one month.
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 1 May 2026.
Related trials for COVID-19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
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.
Daniel Pecos-Martin, PhD study director
Alcala University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuromodulation group in people with COVID-19 and Musculoskeletal Pain, run by University of Alcala 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 4 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 1 May 2026. 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. Some participants in this study may receive a placebo. 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?
Visual Analogue Scale (VAS) (time frame: Change from Baseline at one month.). 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 1 May 2026.