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L'essai clinique NCT07269925 (PENS-DOSE) pour Douleur à l'épaule est pas encore en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici. | ||
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Impact des différentes fréquences électriques utilisées en neuromodulation percutanée sur la force musculaire et les seuils de douleur à la pression (PENS-DOSE) 30
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L'essai clinique NCT07269925 (PENS-DOSE) est une étude interventionnel pour Douleur à l'épaule. Son statut actuel est : pas encore en recrutement. Le recrutement est prévu pour commencer le 15 février 2026, avec un objectif de 30 participants. Dirigée par Universidad Complutense de Madrid, l'étude devrait être terminée d'ici le 30 juillet 2026. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 15 décembre 2025.
Résumé succinct
Percutaneous electrical nerve stimulation (PENS) involves delivering electrical currents through fine filiform needles inserted near tissues such as muscles, ligaments, or nerves. It has been explored for various chronic pain conditions affecting the cervical and lumbar spine, as well as the upper and lower limbs. Despite its growing clinical use, the overall quality of evidence supporting PENS for chronic musculoske...Afficher plus
Titre officiel
Impact of Different Electrical Frequencies Used in Percutaneous Neuromodulation on Muscle Strength and Pressure Pain Thresholds
Pathologies
Douleur à l'épauleAutres identifiants de l'étude
- PENS-DOSE
- UComplutenseMadrid-PENS
Numéro NCT
Date de début (réel)
2026-02-15
Dernière mise à jour publiée
2025-12-15
Date de fin (estimée)
2026-07-30
Inscription (estimée)
30
Type d'étude
Interventionnel
PHASE
N/A
Statut
Pas encore en recrutement
Mots clés
Percutaneous electrical nerve stimulation
Strength
Pain pressure thresholds
Strength
Pain pressure thresholds
Objectif principal
Traitement
Méthode d'allocation
Randomisé
Modèle d'intervention
Parallèle
Masquage
Double aveugle
Bras / Interventions
| Groupe de participants/Bras | Intervention/Traitement |
|---|---|
ExpérimentalLow Frequency PENS Participants will receive a single session of PENS setting 2 Hz frequency, 250 µs pulse width, 10 minutes duration, with an intensity (mA) sufficient to elicit a visible motor response while remaining comfortable for the patient. | Percutaneous electrical nerve stimulation: Low frequency A single PENS session will be applied under ultrasound guidance using sterile, single-use filiform needles placed in the suprascapular and axillary nerves and connected to an electrostimulator APSe4 (Agupunt, Barcelona). Dosage will be: 2 Hz frequency, 250 µs pulse width, 10 minutes duration, with an intensity (mA) sufficient to elicit a visible motor response while remaining comfortable for the patient. |
ExpérimentalHigh Frequency PENS Participants will receive a single session of PENS setting 100 Hz frequency, 250 µs pulse width, 5-second stimulation followed by 55-second rest, with an intensity (mA) sufficient to elicit a visible motor response while remaining comfortable for the patient and repeated five times. | Percutaneous electrical nerve stimulation: High frequency A single PENS session will be applied under ultrasound guidance using sterile, single-use filiform needles placed in the suprascapular and axillary nerves and connected to an electrostimulator APSe4 (Agupunt, Barcelona).
Dosage will be: 100 Hz frequency, 250 µs pulse width, 5-second stimulation followed by 55-second rest, repeated five times |
Critère principal d'évaluation
Critère secondaire d'évaluation
| Critères d'évaluation | Description de la mesure | Période |
|---|---|---|
Muscle strength | Shoulder external rotator strength will be assessed using a handheld dynamometer (TruStrength, Hawkin Dynamics, USA), previously validated for measuring isometric muscle contraction strength. Participants will perform a standardized isometric external rotation test in a seated position with the elbow flexed at 90°. | Baseline |
Muscle strength | Shoulder external rotator strength will be assessed using a handheld dynamometer (TruStrength, Hawkin Dynamics, USA), previously validated for measuring isometric muscle contraction strength. Participants will perform a standardized isometric external rotation test in a seated position with the elbow flexed at 90°. | Post-intervention (10 minutes) |
| Critères d'évaluation | Description de la mesure | Période |
|---|---|---|
Pain Pressure Thresholds - Latent MTrP | The assessment of pressure pain thresholds (PPT) at the myofascial trigger point (MTrP) will be evaluated three times at each measurement site using a analog algometer, applying a pressure rate of approximately 5 N/s. | Baseline |
Pain Pressure Thresholds - Latent MTrP | The assessment of pressure pain thresholds (PPT) at the myofascial trigger point (MTrP) will be evaluated three times at each measurement site using a analog algometer, applying a pressure rate of approximately 5 N/s. | Post-intervention (10 minutes) |
Pain Pressure Thresholds - Tibialis anterior | The assessment of pressure pain thresholds (PPT) at a distal location (Tibia's anterior) will be evaluated three times at each measurement site using a analog algometer, applying a pressure rate of approximately 5 N/s. | Baseline |
Pain Pressure Thresholds - Tibialis anterior | The assessment of pressure pain thresholds (PPT) at a distal location (Tibia's anterior) will be evaluated three times at each measurement site using a analog algometer, applying a pressure rate of approximately 5 N/s. | Post-intervention (10 minutes) |
Assistant à la participation
Critères d'éligibilité
Âges éligibles
Adulte, Adulte âgé
Âge minimum
18 Years
Sexes éligibles
Tous
- Presence of at least one latent myofascial trigger point (MTrP) in the infraspinatus muscle, identified according to the most recent Delphi consensus criteria.
- Ability to read, understand, and sign the written informed consent form.
- Current pharmacological treatment that may affect muscle tone.
- History of shoulder or spinal surgery.
- Traumatic disorders such as whiplash-associated injuries, dislocations, or fractures.
- Neuropathies, including radiculopathies or myelopathies.
- Severe medical conditions (e.g., tumors, fractures, neurological or systemic diseases).
- Clinically relevant asymmetries.
- Generalized musculoskeletal conditions such as fibromyalgia.
Universidad Complutense de MadridUniversidad Rey Juan CarlosPartie responsable de l'étude
JUAN ANTONIO VALERA CALERO, Investigateur principal, Principal Investigator, Universidad Complutense de Madrid
Contact central de l'étude
Contact: Juan Antonio Valera-Calero, PhD, 0034 653 766 841, [email protected]
1 Centres de l'étude dans 1 pays
Poland
ATMIS, Krakow, Poland, Poland
Juan Antonio Valera-Calero, Contact, 0034 653 766 841, [email protected]