- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT06507761
Thermothérapie dans les douleurs cervicales aiguës non spécifiques
Comparaison de l'effet à court terme des applications de thermothérapie superficielle dans un essai contrôlé randomisé sur les douleurs cervicales aiguës non spécifiques
Neck pain is one of the most common musculoskeletal pain disorders secondary to low back pain. Medical and non-medical treatments such as physiotherapy are applied in its treatment. Patients with nonspecific neck pain (NBA) can be treated with various interventions such as drug therapy, manual therapy, heat and exercise. Although it is frequently used in clinical practice, there is no evidence that superficial thermotherapy (hot or cold) methods effectively relieve neck pain. Therefore, this study aims to compare the short-term effects of superficial hot or cold applications on pain, range of motion and functional status in patients with NBA.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
Turkey
-
Istanbul, Turkey, Turquie (Türkiye), +90
- Nuray ALACA
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Istanbul, Turkey, Turquie (Türkiye), 34752
- Acibadem University
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Being diagnosed with nonspecific neck pain by a doctor,
- To be between the ages of 18-65,
- Neck pain lasting for less than 3 month
- No previous neck or shoulder surgery,
- No shoulder pain due to any cause,
- A tumour or inflammatory disease underlying the neck pain not to be found,
- A clinically underlying stenosis or discogenic problem not to be present.
- Negative results from the following clinical examination tests;
Spurling test, Lhermitte test, Cervical distraction test, Adson test,
Exclusion Criteria:
- Not meeting the inclusion criteria,
- Positive neurological examination (positive motor presence, reflex or sensory abnormalities indicating spinal root compression) or abnormal neurological findings related to nerve compression in the upper limb
- Systemic rheumatological or metabolic diseases or cancer
- Refusal to participate in the study,
- Failure to complete treatment,
- Having any neurological problem
- Severe psychological illnesses
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur factice: Groupe Sham
|
An unrefrigerated room temperature Cold Pack will be wrapped in a towel and applied to the patient's posterior neck and back for 15 minutes while the patient is lying face down. |
|
Comparateur actif: Groupe de packs chauds
|
Hot pack (55-60 degrees) application will be wrapped in a towel and applied to the back side neck and back of the patient for 15 minutes while the patient is lying face down. |
|
Comparateur actif: Groupe de compresses froides
|
Cold pack application (2-4 degrees) will be wrapped in a towel and applied to the patient's back side neck and back for 15 minutes while the patient is lying prone. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
The Numerical Rating Scale (NPRS-11)
Délai: Change from baseline pain score at 3th day
|
The Numerical Rating Scale (NPRS-11) is an 11-point scale for self-report of pain. It is the most commonly used unidimensional pain scale. The respondent selects a whole number (integers 0-10) that best reflects the intensity (or other quality if requested of his/her pain.0 point is the minimum and 10 point is the maximum. The higher the score, the more severe the pain. |
Change from baseline pain score at 3th day
|
|
Range of Motion
Délai: Change from baseline range of motion at 3th day
|
CROM device will be used. The active range of motion of each individual will be measured and measured in accordance with the manufacturer's procedures |
Change from baseline range of motion at 3th day
|
|
Global Rating of Change scale (Patient Satisfaction)
Délai: Global Rating of Change assessed on the third day relative to baseline.
|
All participants were asked to rate their condition on the third day compared with baseline by indicating whether they had improved significantly, improved slightly, remained unchanged, deteriorated slightly, or deteriorated significantly, on a scale ranging from -2 to +2, with higher scores indicating greater improvement. |
Global Rating of Change assessed on the third day relative to baseline.
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Neck disability index
Délai: Change from baseline disability scale at 3th day
|
Neck-related disability was assessed using the 10-item Neck Disability Index (NDI). Each item is scored from 0 (no disability) to 5 (maximum disability), resulting in a total score ranging from 0 to 50. Higher scores indicate greater neck-related disability. |
Change from baseline disability scale at 3th day
|
|
Pressure Pain Threshold
Délai: Change from baseline Pressure Pain Threshold at 3th day
|
Pressure pain threshold (PPT) was assessed using a handheld digital pressure algometer at 12 standardized bilateral anatomical sites, including cervical paravertebral and upper trapezius regions. Pressure was applied perpendicular to the skin at a rate of approximately 0.5 kg/cm²/s until the participant first reported that the sensation had changed from pressure to pain. Three measurements were obtained at each site, and the mean values were used to derive global cervical and trapezius pressure pain threshold scores. Higher PPT values indicated lower mechanical pain sensitivity. |
Change from baseline Pressure Pain Threshold at 3th day
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
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
- La douleur
- Manifestations neurologiques
- Infections des voies respiratoires
- Infections
- Infections par virus à ARN
- Maladies virales
- Maladies des voies respiratoires
- Infections à Picornaviridae
- Conditions pathologiques, signes et symptômes
- Signes et symptômes
- Rhume
- La douleur du cou
- acide salicylhydroxamique
Autres numéros d'identification d'étude
- 2024/9/340
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
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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