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

Primary Purpose

De Quervain Disease

Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Extracorporeal Shockwave therapy
Traditional physical therapy program
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for De Quervain Disease focused on measuring Extracorporeal Shockwave therapy :ESWT, Ultrasonography US, HandGrip Strenght, De Quervain Tenosynovitis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mostafa Gomaa Mahmoud

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

The experimental Group A

The control Group B

Arm Description

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).

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

Outcomes

Primary Outcome Measures

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.
Ultrasonographic Changes: Color Doppler activity
Ultrasonography

Secondary Outcome Measures

Pain intensity level assessment :
VAS will be used by the patient to mark his/her level of pain on visual analogue scale.
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.
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).
Pinch grip Strength assessment:
The key pinch will be tested with a Baseline hydraulic pinch gauge (Baseline®, Irvington, NY, USA)

Full Information

First Posted
March 12, 2023
Last Updated
March 12, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05782114
Brief Title
Efficacy of Extracorporeal Shockwave Therapy on Ultrasonographic Changes in de Quervain Tenosynovitis
Official Title
Efficacy Of Extracorporeal Shockwave Therapy On Ultrasonographic Changes, Pain, Function And Grip Strength In De Quervain Tenosynovitis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 1, 2023 (Anticipated)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
De Quervain Disease
Keywords
Extracorporeal Shockwave therapy :ESWT, Ultrasonography US, HandGrip Strenght, De Quervain Tenosynovitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Extracorporeal Shockwave therapy &Traditional physical therapy program
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
The experimental Group A
Arm Type
Experimental
Arm Description
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).
Arm Title
The control Group B
Arm Type
Active Comparator
Arm Description
Traditional physical therapy program (Instruction to wear Thumb Spica splint, Ultrasound therapy, stretching exercise & strengthening exercise) (two sessions per week for 4 weeks).
Intervention Type
Other
Intervention Name(s)
Extracorporeal Shockwave therapy
Intervention Description
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
Intervention Name(s)
Traditional physical therapy program
Intervention Description
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:
Primary Outcome Measure Information:
Title
Ultrasonographic Changes: Thickness in tendons:
Description
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.
Time Frame
Up to Four weeks
Title
Ultrasonographic Changes: Color Doppler activity
Description
Ultrasonography
Time Frame
Up to Four weeks
Secondary Outcome Measure Information:
Title
Pain intensity level assessment :
Description
VAS will be used by the patient to mark his/her level of pain on visual analogue scale.
Time Frame
Up to Four weeks
Title
Assessment of upper limb function:
Description
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.
Time Frame
Up to Four weeks
Title
Handgrip Strength assessment:
Description
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).
Time Frame
Up to Four weeks
Title
Pinch grip Strength assessment:
Description
The key pinch will be tested with a Baseline hydraulic pinch gauge (Baseline®, Irvington, NY, USA)
Time Frame
Up to Four weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mostafa G Mahmoud, phd
Phone
0201122425299
Ext
0201010792839
Email
darsh9lover@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fatma S Amen
Organizational Affiliation
Profeesor of Basic Science / Faculty of Physical therapy/ Cairo university
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nabil M Ismail
Organizational Affiliation
Assistant Prof. of Basic Science/ Faculty of Physical therapy/ Cairo university
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Doaa A Elimy
Organizational Affiliation
Lecturer of Basic Science /Faculty of Physical therapy/ Cairo university
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ahmed S Abd El Basset
Organizational Affiliation
Lecturer of Radiology / Faculty of Medicine/ Beni Suef University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mostafa Gomaa Mahmoud
City
Cairo
Country
Egypt

12. IPD Sharing Statement

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

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