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

March 12, 2023 updated by: Mostafa Gomaa Mahmoud Ali, Cairo University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Cairo, Egypt
        • Mostafa Gomaa Mahmoud

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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).
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.
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:
Active Comparator: 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).
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:

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ultrasonographic Changes: Thickness in tendons:
Time Frame: 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.
Up to Four weeks
Ultrasonographic Changes: Color Doppler activity
Time Frame: Up to Four weeks
Ultrasonography
Up to Four weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Principal Investigator: Doaa A Elimy, Lecturer of Basic Science /Faculty of Physical therapy/ Cairo university
  • Principal Investigator: 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: Ahmed S Abd El Basset, Lecturer of Radiology / Faculty of Medicine/ Beni Suef University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2023

Primary Completion (Anticipated)

April 1, 2024

Study Completion (Anticipated)

August 1, 2024

Study Registration Dates

First Submitted

March 12, 2023

First Submitted That Met QC Criteria

March 12, 2023

First Posted (Actual)

March 23, 2023

Study Record Updates

Last Update Posted (Actual)

March 23, 2023

Last Update Submitted That Met QC Criteria

March 12, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P.T.REC/012/004162

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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