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

NCT05782114 | Unknown

• 1 other identifier: P.T.REC/012/004162
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

De Quervain Disease

Keywords

Extracorporeal Shockwave therapy :ESWT; Ultrasonography US; HandGrip Strenght; De Quervain Tenosynovitis

Outcome Measures

Primary Outcomes (2)

• Ultrasonographic Changes: Thickness in tendons:

  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.

  Up to Four weeks

• Ultrasonographic Changes: Color Doppler activity

  Ultrasonography

  Up to Four weeks

Secondary Outcomes (4)

• Pain intensity level assessment :

  Up to Four weeks

• Assessment of upper limb function:

  Up to Four weeks

• Handgrip Strength assessment:

  Up to Four weeks

• Pinch grip Strength assessment:

  Up to Four weeks

Study Arms (2)

The experimental Group A

EXPERIMENTAL

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; Other: Traditional physical therapy program

The control Group B

ACTIVE COMPARATOR

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

Interventions

Extracorporeal Shockwave therapy 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.

The experimental Group A

Traditional physical therapy program 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; The experimental Group A

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Mostafa Gomaa Mahmoud

Cairo, Egypt

Location

MeSH Terms

Conditions

De Quervain Disease

Interventions

Extracorporeal Shockwave Therapy

Condition Hierarchy (Ancestors)

Tendon Entrapment; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Fatma S Amen

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

  PRINCIPAL INVESTIGATOR

• Nabil M Ismail

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

  PRINCIPAL INVESTIGATOR

• Doaa A Elimy

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

  PRINCIPAL INVESTIGATOR

• Ahmed S Abd El Basset

  Lecturer of Radiology / Faculty of Medicine/ Beni Suef University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mostafa G Mahmoud, phd

CONTACT

0201122425299; darsh9lover@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Model Details: Extracorporeal Shockwave therapy \&Traditional physical therapy program

Study Record Dates

• First Submitted: March 12, 2023
• First Posted: March 23, 2023
• Study Start: April 1, 2023
• Primary Completion: April 1, 2024
• Study Completion: August 1, 2024
• Last Updated: March 23, 2023

Record last verified: 2023-03

Locations

EG (1)