- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07926789
Neuromuscular Taping on Muscle Pain in Patients With Degenerative Osteoarticular Disease of the Spine
Randomized Clinical Trial to Evaluate the Efficacy of Neuromuscular Taping on Muscle Pain in Patients With Degenerative Osteoarticular Disease of the Spine
The goal of this clinical trial is to learn if neuromuscular taping (kinesio taping), added to a standard exercise program, reduces muscle pain in adults with chronic neck pain or chronic low back pain caused by degenerative disease of the spine (such as facet joint osteoarthritis, spondylosis, or degenerative disc disease). The main questions it aims to answer are:
Does neuromuscular taping, applied once a week for 3 weeks in addition to standard exercise therapy, reduce muscle pain more than placebo taping?
Researchers will compare neuromuscular taping applied with a muscle and fascial technique to placebo taping (the same tape placed on the same area without tension or therapeutic technique) to see if the active taping provides greater pain relief.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Noemí Casaponsa
- Numéro de téléphone: 43197 0034938960025
- E-mail: recerca@csapg.cat
Lieux d'étude
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Barcelona, Espagne
- Consorci Sanitari Alt Penedès Garraf
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Contact:
- Sandra Herrero
- Numéro de téléphone: 0034938960025
- E-mail: aherrerol@csapg.cat
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Men and women aged 18 years or older
- Persistent pain (duration of more than 3 months) with a diagnosis of chronic -neck pain or chronic low back pain due to degenerative joint disease
- Stable pain treatment, with no changes expected during the following 3 weeks
- Willingness to participate and signed informed consent
Exclusion Criteria:
- Cervicobrachialgia (neck pain radiating to the arm)
- Lumbosciatica (low back pain radiating to the leg)
- Pregnancy in the second or third trimester
- Skin conditions that contraindicate the application of neuromuscular tape
- Allergy to adhesive materials
- Thrombosis or risk of thrombosis
- Severe trauma that has not been previously examined and diagnosed by a physician
- Participation in another clinical trial involving an experimental intervention during the period of this trial and/or with a visit schedule incompatible with this trial
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Intervention
Participants will have neuromuscular tape applied to the neck or lower back after the first exercise session of each week, and remove it on the fourth day |
The muscle technique consists of applying the tape without stretching it. Either the muscle or the skin is placed under stretch, but the tape itself is applied with no tension along its entire length. The base anchor is applied with the body segment in a neutral position; the target muscle is then stretched and the tape is laid over it. Finally, the segment is returned to the neutral position and the end anchor is applied. This technique is used to inhibit muscle tone. Once the tape has been applied, patients will be instructed to remove it on the fourth day. They may carry on with their normal daily activities and may get the tape wet when washing or showering. If the tape causes significant discomfort, patients may remove it early and must record this in their pain diary. If the tape comes off before the fourth day, patients must also record this in the diary. |
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Comparateur factice: Control
These patients will have the same tape placed on the same area without tension or therapeutic technique |
The same tape placed on the same area without tension or therapeutic technique |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Pain Intensity
Délai: From enrollment to the end of treatment at 4 weeks
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Pain intensity, measured using a Visual Analog Scale (VAS). Pain will be recorded before the first treatment session of each week. Since treatment consists of two physiotherapy sessions per week for four weeks, the VAS will be recorded at the start of sessions 1, 3, 5, and 8, the last of which corresponds to the final day of treatment. In addition, patients will complete a pain diary every day between treatment sessions. |
From enrollment to the end of treatment at 4 weeks
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Collaborateurs et enquêteurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- CSAPG-31
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
IPD (without personal identification data) could be shared by requirement from other researchers after the end of the study, and only for research purposes and previous approval of promotor center of the study (CSAPG). Anyway, Spanish and European Union legal policy about data protection will strictly be followed (IPD will not be transferred outside European Union).
Délai de partage IPD
After publication of main results of the study
Critères d'accès au partage IPD
IPD will be shared only for scientific research purposes and following the Spanish and European Union normative law about data protection. The requirements will be directed to the IP of the study. The IP will evaluate the request to verify and evaluate the data that is requested and the purposes for which it is requested. Next, the IP will transfer the request to the promotor center the study for the final decision.
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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