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

NCT ID: NCT05782114

Last Updated: 2023-03-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-01
• Study Completion Date: 2024-08-31

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.

Conditions

De Quervain Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

The experimental Group A

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).

Group Type: EXPERIMENTAL

Extracorporeal Shockwave therapy

Intervention Type: OTHER

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

Intervention Type: OTHER

1. Instruction to wear Thumb Spica splint:

The Thumb Spica splint will be used for 4 weeks for both groups of patients.

2. Ultrasound Therapy:

Therapeutic Ultrasound parameters will be mode: continuous, duration: 5 minutes, intensity: 1.2watt/cm2 and frequency: 1MHZ.

3. Stretching exercise:

1. Self-stretch of the thenar eminence: 2. Opposition stretches: 3. Wrist stretch:

4) Strengthening exercise:

1. Resisted exercise for thumb extension:

2. Resisted exercise for thumb abduction:

3. Resisted exercise for thumb opposition:

4. Wrist radial deviation strengthening:

5. Grip strengthening:

6. Finger spring:

The control Group B

Traditional physical therapy program (Instruction to wear Thumb Spica splint, Ultrasound therapy, stretching exercise \& strengthening exercise) (two sessions per week for 4 weeks).

Group Type: ACTIVE_COMPARATOR

Traditional physical therapy program

Intervention Type: OTHER

1. Instruction to wear Thumb Spica splint:

The Thumb Spica splint will be used for 4 weeks for both groups of patients.

2. Ultrasound Therapy:

Therapeutic Ultrasound parameters will be mode: continuous, duration: 5 minutes, intensity: 1.2watt/cm2 and frequency: 1MHZ.

3. Stretching exercise:

1. Self-stretch of the thenar eminence: 2. Opposition stretches: 3. Wrist stretch:

4) Strengthening exercise:

1. Resisted exercise for thumb extension:

2. Resisted exercise for thumb abduction:

3. Resisted exercise for thumb opposition:

4. Wrist radial deviation strengthening:

5. Grip strengthening:

6. Finger spring:

Interventions

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.

Intervention Type: OTHER

Traditional physical therapy program

1. Instruction to wear Thumb Spica splint:

The Thumb Spica splint will be used for 4 weeks for both groups of patients.

2. Ultrasound Therapy:

Therapeutic Ultrasound parameters will be mode: continuous, duration: 5 minutes, intensity: 1.2watt/cm2 and frequency: 1MHZ.

3. Stretching exercise:

1. Self-stretch of the thenar eminence: 2. Opposition stretches: 3. Wrist stretch:

4) Strengthening exercise:

1. Resisted exercise for thumb extension:

2. Resisted exercise for thumb abduction:

3. Resisted exercise for thumb opposition:

4. Wrist radial deviation strengthening:

5. Grip strengthening:

6. Finger spring:

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Mostafa Gomaa Mahmoud Ali

Assistant Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fatma S Amen

Role: PRINCIPAL_INVESTIGATOR

Profeesor of Basic Science / Faculty of Physical therapy/ Cairo university

Nabil M Ismail

Role: PRINCIPAL_INVESTIGATOR

Assistant Prof. of Basic Science/ Faculty of Physical therapy/ Cairo university

Doaa A Elimy

Role: PRINCIPAL_INVESTIGATOR

Lecturer of Basic Science /Faculty of Physical therapy/ Cairo university

Ahmed S Abd El Basset

Role: PRINCIPAL_INVESTIGATOR

Lecturer of Radiology / Faculty of Medicine/ Beni Suef University

Locations

Mostafa Gomaa Mahmoud

Cairo, , Egypt

Countries

Egypt

Central Contacts

Mostafa G Mahmoud, phd

Role: CONTACT

darsh9lover@gmail.com

0201122425299 ext. 0201010792839

Other Identifiers

P.T.REC/012/004162

Identifier Type: -

Identifier Source: org_study_id