- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06723821
Noninvasive Neuromodulation in the Management of Post-COVID Musculoskeletal Pain
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.
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Madrid
-
Alcalá de Henares, Madrid, Spain, 28805
- Centro Investigación Fisioterapia y Dolor
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Neuromodulation experimental group
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. |
During the 12 sessions of which the treatment consists in applying 60 minutes of microcurrent in low intensity.
|
|
Sham Comparator: Neuromodulation sham group
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 |
During the 12 sessions of which the treatment consists in applying 60 minutes of sham microcurrent in low intensity.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
Change from Baseline at one month.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
DN4 scale
Time Frame: Change from Baseline at one month.
|
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.
|
Change from Baseline at one month.
|
|
Pittsburg Sleep Quality Index score
Time Frame: Change from Baseline at one month.
|
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.
|
Change from Baseline at one month.
|
|
Hospital Anxiety and Depression Scale (HAND)
Time Frame: Change from Baseline at one month
|
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
|
Change from Baseline at one month
|
|
Quality of life SF12
Time Frame: Change from Baseline at one month.
|
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.
|
Change from Baseline at one month.
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Daniel Pecos-Martin, PhD, Alcalá University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Musculoskeletal Diseases
- Muscular Diseases
- Respiratory Tract Infections
- Infections
- RNA Virus Infections
- Virus Diseases
- Respiratory Tract Diseases
- Lung Diseases
- Pneumonia, Viral
- Pneumonia
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- COVID-19
- Musculoskeletal Pain
Other Study ID Numbers
- CEIM/2022/6/121
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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