- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07695064
Comparing the Effects of Manual Cross Friction Massage Versus Instrument-Assisted Soft Tissue Mobilization on Pain, Range of Motion, And Functional Disability in Patients With Chronic Lateral Epicondylitis: A Randomized Controlled Trial
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
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KPK
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Peshawar, KPK, Pakistan, 25000
- Ibadat International University, Islamabad
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
La description
Inclusion Criteria:
- Both male and female aged between 18 to 60 years with a clinical diagnosis of lateral elbow pain lasting for≥ 6 months duration VAS score ≥ 4 during resisted wrist extension or grip activity ≥1 of the following tests being positive . Mill's test pain on passive wrist flexion and elbow extension Cozen's test pain on resisted wrist extension, elbow extended, wrist in flexion and medial deviation .
Painful palpation at the origin of the ECRB or lateral epicondyle
Exclusion Criteria:
- Participants will be excluded as:
History of recent fracture,dislocation,or surgery near the elbow joint in the last 3 month Neurological or systemic inflammatory conditions (e.g., rheumatoid arthritis) Current use of corticosteroid injections in the elbow region within the past 6 weeks Previous physiotherapy interventions for the same complaint in the last 3 months.
Skin disorders or open wounds near the treatment area.
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 |
|---|---|
|
Expérimental: Manual Cross Friction Massage (CFM)
Arm Description: Patient seated , elbow flexed ~90 degree , forearm pronated , extensor tendon exposed and released.
Thumb / index finger applies firm transverse pressure .
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Patient seated , elbow flexed ~90 degree , forearm pronated , extensor tendon exposed and released.
Thumb / index finger applies firm transverse pressure .
Short , deep ,rhythmic strokes perpendicular to ECRB tendon fibers (5 to 10 min ).Total duration 35 - 40 mins.
3 sessions per week for 6 weeks.
|
|
Comparateur actif: Group B: Instrument-Assisted Soft Tissue Mobilization (IASTM)
Seated,Elbow flexed ~ 90 degree , forearm pronated, extensor tendon exposed and relaxed.
Stainless steel IASTMCurve bar S shape , dual grip tool was used with moderate ,tolerable pressure .
|
Seated,Elbow flexed ~ 90 degree , forearm pronated, extensor tendon exposed and relaxed.
Stainless steel IASTMCurve bar S shape , dual grip tool was used with moderate ,tolerable pressure .
Longitudinal sweeping (1-2 min ) , Cross fiber stokes (1-2 min), Fanning over tender point ( 1- 2min).
Flushing stokes (1min).40
-45 mins total time .
3 sessions per week for 6 weeks.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Visual Analog Scale.
Délai: Assessments were performed at baseline (week 0) and post intervention (week 6).
|
A Visual Analogue Scale (VAS) was used to measure pain intensity during rest.
The level of pain was recorded on a 10 cm line where 0 was classified as "no pain" and 10 was classified as "worst possible pain".
Subjects were asked to indicate their pain level by placing a mark along this horizontal line
|
Assessments were performed at baseline (week 0) and post intervention (week 6).
|
|
Goniometer
Délai: Assessments was performed at baseline (week 0) and post intervention (week 6).
|
ROM measured was used a standard universal goniometer, which is considered a valid, reliable, and widely accepted clinical tool for assessing joint angles in musculoskeletal conditions.
Measurements were taken for wrist flexion, wrist extension, and elbow movements, following standardized positioning and landmark alignment to ensure consistency and accuracy.
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Assessments was performed at baseline (week 0) and post intervention (week 6).
|
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Patient-Rated Tennis Elbow Evaluation (PRTEE) questionnaire
Délai: Assessments was performed at baseline (week 0) and post intervention (week 6).
|
Patient-Rated Tennis Elbow Evaluation (PRTEE) questionnaire The Patient-Rated Tennis Elbow Evaluation (PRTEE) questionnaire is an instrument that has been developed specifically for use with this disorder [16].
It takes the form of a 15-item questionnaire, with five items addressing pain and 10 concerned with functional deficit.
For each item, the respondent uses a 0- 10 numerical scale to rate the average pain or difficulty they have experienced over the previous week while carrying out various activities that are commonly painful in tennis elbow.
The marking system ensures that pain and function are weighted equally in the total score.
Higher scores represent greater se- verity and the maximum score is 100
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Assessments was performed at baseline (week 0) and post intervention (week 6).
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Collaborateurs et enquêteurs
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
Autres numéros d'identification d'étude
- IIUI/RERC/ADT/2026/01/206
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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