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

De Quervain Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05782114
• Other study ID #: P.T.REC/012/004162
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: August 2024

Study information

• Verified date: March 2023
• Source: Cairo University
• Contact: Mostafa G Mahmoud, phd
• Phone: 0201122425299
• Email: darsh9lover[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: August 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• De Quervain Disease
• Tenosynovitis

Intervention

Other:
• Extracorporeal Shockwave therapy
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.
• Traditional physical therapy program
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:

Locations

Country	Name	City	State
Egypt	Mostafa Gomaa Mahmoud	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Ultrasonographic Changes: Color Doppler activity	Ultrasonography	Up to Four weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	Pinch grip Strength assessment:	The key pinch will be tested with a Baseline hydraulic pinch gauge (Baseline®, Irvington, NY, USA)	Up to Four weeks