Efficacy of Extracorporeal Shockwave Therapy on Ultrasonographic Changes in de Quervain Tenosynovitis

Study Overview
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Brief Summary
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The current study will be conducted to explore the efficacy of ESWT on ultrasonographic changes, pain intensity level, upper limb function and hand grip strength in patients with de Quervain tenosynovitis.

Detailed Description
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De Quervain tenosynovitis (DQT) is a painful condition involving the tendons of the abductor pollicis longus (APL) and extensor pollicis brevis (EPB). The pathogenesis is generally defined as a stenosing condition of the first dorsal compartment of the wrist, characterized by thickening of the extensor retinaculum of APL and EPB, which can cause tendon gliding difficulties and impingement between the tendons and their fibrous sheaths. The prevalence rate of DQT in the general population is 0.5% for males and 1.3% for females, with peak prevalence at the age of 40-60 years. Female prevalence is 6 to 10 times higher than that in men. De Quervain tenosynovitis is a repetitive strain injury consider postures where the thumb is held in abduction and extension to be predisposing factors. De Quervain tenosynovitis incidence increased by virtue of modern life conditions such as excessive computer use and increased use of cellular phones. However, little research has been carried out to determine the therapeutic effects of ESWT in DQT, and up till now, there is a gap in literature that explore ESWT efficacy on ultrasonographic changes of DQT. So This current study will be conducted to explore the efficacy of ESWT on ultrasonographic changes, pain intensity level, upper limb function and hand grip strength in patients with de Quervain tenosynovitis. Sixty patients from both genders will be involved in this study and will be randomly subdivided into two equal groups in number. First Group (A) (Experimental Group) will receive radial Extracorporeal Shockwave therapy plus Traditional physical therapy program and the second Group (B) (Control Group): This group will receive Traditional physical therapy program.

Official Title
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Efficacy Of Extracorporeal Shockwave Therapy On Ultrasonographic Changes, Pain, Function And Grip Strength In De Quervain Tenosynovitis

Conditions
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De Quervain Disease

Intervention / Treatment
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* Other: Extracorporeal Shockwave therapy
* Other: Traditional physical therapy program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age from 18 to 65 years Both genders (males and females). Normal BMI ranges between 18.5:24.9 kg/m2. Patients will be referred from an orthopedist with diagnosis of DQT. Chronic pain more than 2 months. No history of undergoing physiotherapy modalities or corticosterone injection therapies for any reasons during the past month. De Quervain tenosynovitis patients will be diagnosed based on the standard criteria, including pain and tenderness in the lateral wrist and a positive result for the Finkelstein test. Exclusion Criteria: History of undergoing physiotherapy modalities or corticosterone injection therapies for any reason during the past month. Subjects with other neurological disorders rheumatologic diseases causing wrist pain. Pregnancy. History of fracture or surgery on the hand. Severe trauma, and coagulation disorders.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Extracorporeal Shockwave therapy &Traditional physical therapy program
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: The experimental Group A<br>Extracorporeal Shockwave therapy (four sessions one session per week) +Traditional physical therapy program (Instruction to wear Thumb Spica splint, Ultrasound therapy, stretching exercise & strengthening exercise) (two sessions per week for 4 weeks). | Other: Extracorporeal Shockwave therapy<br>* The shockwave will be applied for the experimental group (Group A). The patients will be positioned on a chair, and the hand with the disorder will be placed on a surface with the radio ulnar joint will be in mid position and the thumb will be directed up. will be 1000 impulses with 2 bar pressure at a frequency of 15 Hz on the radial head and focused on the tissue surrounding the maximal pain point.<br>Other: Traditional physical therapy program<br>* Instruction to wear Thumb Spica splint: The Thumb Spica splint will be used for 4 weeks for both groups of patients. Ultrasound Therapy: Therapeutic Ultrasound parameters will be mode: continuous, duration: 5 minutes, intensity: 1.2watt/cm2 and frequency: 1MHZ. Stretching exercise: 1. Self-stretch of the thenar eminence: 2. Opposition stretches: 3. Wrist stretch: 4) Strengthening exercise: Resisted exercise for thumb extension: Resisted exercise for thumb abduction: Resisted exercise for thumb opposition: Wrist radial deviation strengthening: Grip strengthening: Finger spring:<br>|
| Active Comparator: The control Group B<br>Traditional physical therapy program (Instruction to wear Thumb Spica splint, Ultrasound therapy, stretching exercise & strengthening exercise) (two sessions per week for 4 weeks). | Other: Traditional physical therapy program<br>* Instruction to wear Thumb Spica splint: The Thumb Spica splint will be used for 4 weeks for both groups of patients. Ultrasound Therapy: Therapeutic Ultrasound parameters will be mode: continuous, duration: 5 minutes, intensity: 1.2watt/cm2 and frequency: 1MHZ. Stretching exercise: 1. Self-stretch of the thenar eminence: 2. Opposition stretches: 3. Wrist stretch: 4) Strengthening exercise: Resisted exercise for thumb extension: Resisted exercise for thumb abduction: Resisted exercise for thumb opposition: Wrist radial deviation strengthening: Grip strengthening: Finger spring:<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ultrasonographic Changes: Thickness in tendons: | Ultrasonography which is a valid and reliable measure to evaluate tendon structural changes including: Tendon thickness APL & EPB tendons in mm. Thickness of hypoechoic area in mm. | Up to Four weeks | 
| Ultrasonographic Changes: Color Doppler activity | Ultrasonography | Up to Four weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity level assessment : | VAS will be used by the patient to mark his/her level of pain on visual analogue scale. | Up to Four weeks | 
| Assessment of upper limb function: | by Q-DASH (The Arabic Quick-DASH questionnaire) is an 11-item self-report questionnaire extracted from the full-length version of the DASH concerning the patient's health status. | Up to Four weeks | 
| Handgrip Strength assessment: | Baseline hydraulic hand dynamometer Hand grip strength as a measure of functional performance will be measured using the Baseline hydraulic hand dynamometer (Baseline®, Irvington, NY, USA). | Up to Four weeks | 
| Pinch grip Strength assessment: | The key pinch will be tested with a Baseline hydraulic pinch gauge (Baseline®, Irvington, NY, USA) | Up to Four weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Extracorporeal Shockwave therapy :ESWT, Ultrasonography US, HandGrip Strenght, De Quervain Tenosynovitis