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

Not Applicable

Not yet recruiting

• Conditions: De Quervain Disease
• Interventions: Other: Extracorporeal Shockwave therapy; Other: Traditional physical therapy program

• Registration Number: NCT05782114
• Lead Sponsor: Cairo University

Brief Summary

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

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.

Study Timeline

• Status Verified: 2023-03
• Study First Submitted: 2023-03-12
• Study First Submitted QC: 2023-03-12
• Last Update Submitted: 2023-03-12
• Study First Posted: 2023-03-23
• Last Update Posted: 2023-03-23
• Study Start: 2023-04-01
• Primary Completion: 2024-04
• Study Completion: 2024-08

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Age from 18 to 65 years
2. Both genders (males and females).
3. Normal BMI ranges between 18.5:24.9 kg/m2.
4. Patients will be referred from an orthopedist with diagnosis of DQT.
5. Chronic pain more than 2 months.
6. No history of undergoing physiotherapy modalities or corticosterone injection therapies for any reasons during the past month.
7. 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

1. History of undergoing physiotherapy modalities or corticosterone injection therapies for any reason during the past month.
2. Subjects with other neurological disorders rheumatologic diseases causing wrist pain.
3. Pregnancy.
4. History of fracture or surgery on the hand.
5. Severe trauma, and coagulation disorders.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The experimental Group A	Extracorporeal Shockwave therapy	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).
The experimental Group A	Traditional physical therapy program	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).
The control Group B	Traditional physical therapy program	Traditional physical therapy program (Instruction to wear Thumb Spica splint, Ultrasound therapy, stretching exercise \& strengthening exercise) (two sessions per week for 4 weeks).

Primary Outcome Measures

Name	Time	Method
Ultrasonographic Changes: Thickness in tendons:	Up to Four weeks	Ultrasonography which is a valid and reliable measure to evaluate tendon structural changes including: 1. Tendon thickness APL \& EPB tendons in mm.; 2. Thickness of hypoechoic area in mm.
Ultrasonographic Changes: Color Doppler activity	Up to Four weeks	Ultrasonography

Secondary Outcome Measures

Name	Time	Method
Pain intensity level assessment :	Up to Four weeks	VAS will be used by the patient to mark his/her level of pain on visual analogue scale.
Pinch grip Strength assessment:	Up to Four weeks	The key pinch will be tested with a Baseline hydraulic pinch gauge (Baseline®, Irvington, NY, USA)
Handgrip Strength assessment:	Up to Four weeks	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).
Assessment of upper limb function:	Up to Four weeks	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.

Trial Locations

Locations (1)

Mostafa Gomaa Mahmoud; 🇪🇬 Cairo, Egypt