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Effect Of Shock Waves Therapy On Post Natal De Quarvain Tenosynovitis

7 novembre 2026 mis à jour par: Mai Kamel Anwar, Cairo University

This randomized controlled trial aims to investigate the effect of extracorporeal shock wave therapy (ESWT) on pain, wrist and thumb range of motion, and upper limb function in postpartum women with De Quervain's tenosynovitis.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

De Quervain's tenosynovitis is a musculoskeletal condition affecting the abductor pollicis longus and extensor pollicis brevis tendons within the first dorsal compartment of the wrist. It is associated with pain, tenderness, restricted thumb and wrist movement, and difficulty performing daily activities. Postpartum women may be particularly affected because of repetitive wrist and thumb movements associated with infant care.

Extracorporeal shock wave therapy (ESWT) is a non-invasive treatment modality being investigated for its potential effects on pain reduction and functional recovery in musculoskeletal disorders.

This study is designed as a prospective randomized controlled trial involving 40 postpartum women diagnosed with De Quervain's tenosynovitis. Participants will be randomly allocated into two equal groups of 20 women each.

The study group will receive extracorporeal shock wave therapy combined with a therapeutic exercise program consisting of tendon gliding, stretching, and strengthening exercises.

The control group will receive the same therapeutic exercise program without shock wave therapy.

Outcome assessments will be conducted before and after the treatment period. Pain intensity will be evaluated using the Visual Analogue Scale (VAS), wrist and thumb range of motion will be measured using a goniometer, and upper limb function will be assessed using the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire.

The study will compare changes within and between the two groups to evaluate the additional effect of shock wave therapy on pain, range of motion, and upper limb function in postpartum women with De Quervain's tenosynovitis.

Type d'étude

Interventionnel

Inscription (Estimé)

40

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

  • Nom: Elham Shahat Hassan, PhD

Lieux d'étude

  • Egypte
      • Giza, Egypte
        • Kasr El Ainy University Hospital
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

25 ans à 35 ans (Adulte)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Femelle

La description

Inclusion Criteria:

  1. Women in the postpartum period of > 6 months following labor
  2. Age: Between 25 and 35 years old.
  3. Body mass index: Between 25-30 kg / m2
  4. Diagnosis: Clinically diagnosed with De Quervain tenosynovitis by an orthopedic specialist or confirmed through clinical evaluation.
  5. Pain Severity: Presenting with moderate to severe pain (≥ 4 on the Visual Analogue Scale).
  6. Obstetric History: Multipara women (Cesarean section or normal labor)
  7. Stage of Condition Chronic stage: symptoms > 6 weeks

Exclusion Criteria:

  1. Previous Surgery: History of surgical intervention on the affected wrist or thumb.
  2. Skin Conditions: Open wounds, infections, or dermatological diseases at the application site that may interfere with shockwave therapy.
  3. Pregnancy: Pregnant or lactating women.
  4. Medication Use: Currently taking systemic corticosteroids, anticoagulants, or nonsteroidal anti-inflammatory drugs (NSAIDs) that may influence study outcomes.
  5. Pacemaker or Metal Implants: Presence of a cardiac pacemaker or metal implants near the treatment area.
  6. Other Physiotherapy: Receiving concurrent physiotherapy treatment for the same condition during the study period.
  7. Non-compliance: Inability or unwillingness to attend treatment sessions or follow instructions throughout the study duration.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

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: Shock Wave Therapy + Therapeutic Exercises

Twenty postpartum women with De Quervain's tenosynovitis will receive extracorporeal shock wave therapy (ESWT) in addition to a therapeutic exercise program consisting of tendon gliding, stretching, and strengthening exercises. The exercise program will be performed for 30 minutes daily over four weeks.
Dispositif: Shock Wave Therapy

Extracorporeal shock wave therapy will be applied to the affected first dorsal compartment of the wrist using a radial shock wave device. Treatment parameters will include 1,000 impulses per session, with frequencies ranging from 18 to 21 Hz and pressure settings ranging from 1.4 to 1.8 bar, according to the study protocol.

Autres noms:
  • Extracorporeal Shock Wave Therapy (ESWT)
Autre: Therapeutic Exercises

A structured therapeutic exercise program consisting of tendon gliding, stretching, active range-of-motion exercises, and progressive strengthening exercises targeting the wrist and thumb. Exercises will be performed for 30 minutes daily over four weeks, according to participants' tolerance.
Comparateur actif: Therapeutic Exercises

Twenty postpartum women with De Quervain's tenosynovitis will receive a therapeutic exercise program consisting of tendon gliding, stretching, and strengthening exercises for 30 minutes daily over four weeks, without shock wave therapy.
Autre: Therapeutic Exercises

A structured therapeutic exercise program consisting of tendon gliding, stretching, active range-of-motion exercises, and progressive strengthening exercises targeting the wrist and thumb. Exercises will be performed for 30 minutes daily over four weeks, according to participants' tolerance.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Pain Intensity Measured by Visual Analogue Scale (VAS)
Délai: 4 weeks

Pain intensity will be measured using a 10-cm Visual Analogue Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain). Lower scores indicate less pain. Changes in pain intensity will be compared between the study and control groups.
4 weeks

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Wrist Flexion Range of Motion
Délai: 4 weeks

Change in active wrist flexion range of motion, measured in degrees using a universal goniometer. The change will be calculated as the post-treatment measurement minus the baseline measurement.
4 weeks
Wrist Extension Range of Motion
Délai: 4 weeks

Change in active wrist extension range of motion, measured in degrees using a universal goniometer. The change will be calculated as the post-treatment measurement minus the baseline measurement.
4 weeks
Wrist Radial Deviation Range of Motion
Délai: 4 weeks

Change in active wrist radial deviation range of motion, measured in degrees using a universal goniometer. The change will be calculated as the post-treatment measurement minus the baseline measurement.
4 weeks
Wrist Ulnar Deviation Range of Motion
Délai: 4 weeks

Change in active wrist ulnar deviation range of motion, measured in degrees using a universal goniometer. The change will be calculated as the post-treatment measurement minus the baseline measurement.
4 weeks
Thumb Flexion Range of Motion
Délai: 4 weeks

Change in active thumb flexion range of motion, measured in degrees using a universal goniometer. The change will be calculated as the post-treatment measurement minus the baseline measurement.
4 weeks
Thumb Extension Range of Motion
Délai: 4 weeks

Change in active thumb extension range of motion, measured in degrees using a universal goniometer. The change will be calculated as the post-treatment measurement minus the baseline measurement.
4 weeks
Thumb Abduction Range of Motion
Délai: 4 weeks

Change in active thumb abduction range of motion, measured in degrees using a universal goniometer. The change will be calculated as the post-treatment measurement minus the baseline measurement.
4 weeks
Thumb Adduction Range of Motion
Délai: 4 weeks

Change in active thumb adduction range of motion, measured in degrees using a universal goniometer. The change will be calculated as the post-treatment measurement minus the baseline measurement.
4 weeks
Upper Limb Disability Measured by DASH Questionnaire
Délai: 4 weeks

Upper limb function and disability will be assessed using the 30-item Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire. The total score ranges from 0 (no disability) to 100 (maximum disability). Lower scores indicate better upper limb function.
4 weeks

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Cairo University

Les enquêteurs

  • Chaise d'étude: Hala Mohamed Hanafy, PhD, Professor, Cairo University
  • Directeur d'études: Sameh Hussien Samir, PhD, Professor, National Research Centre
  • Directeur d'études: Elham Shahat Hassan, PhD, Ass. Professor, Cairo University

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

20 novembre 2026

Achèvement primaire (Estimé)

20 janvier 2027

Achèvement de l'étude (Estimé)

31 janvier 2027

Dates d'inscription aux études

Première soumission

7 novembre 2026

Première soumission répondant aux critères de contrôle qualité

7 novembre 2026

Première publication (Réel)

13 novembre 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

13 novembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

7 novembre 2026

Dernière vérification

1 novembre 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • P.T.REC/012/006319

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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