De Quervain DiseaseNCT05782114
Efficacy of Extracorporeal Shockwave Therapy on Ultrasonographic Changes in de Quervain Tenosynovitis
A study testing Extracorporeal Shockwave therapy and Traditional physical therapy program in people with De Quervain Disease, run by Cairo University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- De Quervain Disease
- What is being tested?
- Extracorporeal Shockwave therapy and Traditional physical therapy program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2023to Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Extracorporeal Shockwave therapy, Traditional physical therapy program
- Keywords
- Extracorporeal Shockwave therapy :ESWT, Ultrasonography US, HandGrip Strenght, De Quervain Tenosynovitis
- Medical subject headings
- De Quervain Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporeal Shockwave therapyOther
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 programOther
- 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:
- Self-stretch of the thenar eminence: 2. Opposition stretches: 3. Wrist stretch:
- 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:
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Other: Traditional physical therapy program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to Four weeks
Ultrasonographic Changes: Color Doppler activity
Ultrasonography
Measured: Up to Four weeks
Secondary outcomes (4)
Pain intensity level assessment :
VAS will be used by the patient to mark his/her level of pain on visual analogue scale.
Measured: Up to Four weeks
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.
Measured: Up to Four weeks
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).
Measured: Up to Four weeks
Pinch grip Strength assessment:
The key pinch will be tested with a Baseline hydraulic pinch gauge (Baseline®, Irvington, NY, USA)
Measured: Up to Four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2023
- Study start1 Apr 2023 (estimated)
- Primary completionApr 2024 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for De Quervain DiseaseStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Extracorporeal Shockwave therapy \&Traditional physical therapy program
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Gomaa Mahmoud Ali, Cairo University
- Investigators
- Fatma S Amen, Principal investigator, Profeesor of Basic Science / Faculty of Physical therapy/ Cairo universityNabil M Ismail, Principal investigator, Assistant Prof. of Basic Science/ Faculty of Physical therapy/ Cairo universityDoaa A Elimy, Principal investigator, Lecturer of Basic Science /Faculty of Physical therapy/ Cairo universityAhmed S Abd El Basset, Principal investigator, Lecturer of Radiology / Faculty of Medicine/ Beni Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05782114
- Sponsor's protocol ID
- P.T.REC/012/004162
- Status last verified
- Mar 2023
- First submitted
- 12 Mar 2023
- Last updated
- 23 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Of Extracorporeal Shockwave Therapy On Ultrasonographic Changes, Pain, Function And Grip Strength In De Quervain Tenosynovitis
- ClinicalTrials.gov ID
- NCT05782114
- Acronym / sponsor ID
- P.T.REC/012/004162
- Conditions
- De Quervain Disease
- Keywords
- Extracorporeal Shockwave therapy :ESWT, Ultrasonography US, HandGrip Strenght, De Quervain Tenosynovitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (estimated)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 23 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Extracorporeal Shockwave therapy \&Traditional physical therapy program
| Arm | Type | Receives |
|---|---|---|
| The experimental Group A | Experimental | Other: Extracorporeal Shockwave therapy, Other: Traditional physical therapy programExtracorporeal 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). |
| The control Group B | Active comparator | Other: Traditional physical therapy programTraditional physical therapy program (Instruction to wear Thumb Spica splint, Ultrasound therapy, stretching exercise \& strengthening exercise) (two sessions per week for 4 weeks). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extracorporeal Shockwave therapyThe 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 | The experimental Group A |
| Traditional physical therapy program1. 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: | Other | The control Group B, The experimental Group A |
Primary outcome
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.
Ultrasonographic Changes: Color Doppler activity
Time frame: Up to Four weeks
Ultrasonography
4 secondary outcomes
Pain intensity level assessment :
Time frame: Up to Four weeks
Assessment of upper limb function:
Time frame: Up to Four weeks
Handgrip Strength assessment:
Time frame: Up to Four weeks
Pinch grip Strength assessment:
Time frame: Up to Four weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fatma S Amen principal investigator
Profeesor of Basic Science / Faculty of Physical therapy/ Cairo university
Nabil M Ismail principal investigator
Assistant Prof. of Basic Science/ Faculty of Physical therapy/ Cairo university
Doaa A Elimy principal investigator
Lecturer of Basic Science /Faculty of Physical therapy/ Cairo university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extracorporeal Shockwave therapy and Traditional physical therapy program in people with De Quervain Disease, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mostafa G Mahmoud, phd (0201122425299 ext. 0201010792839, darsh9lover@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ultrasonographic Changes: Thickness in tendons: (time frame: Up to Four weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2023.