An interventional study of Extracorporeal Shockwave therapy and Traditional physical therapy program in De Quervain Disease, sponsored by Cairo University. Status unknown at 1 site in Egypt. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-03-23.
Sponsored by Cairo University · Not applicable, Interventional, and Treatment
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.
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.
30 studies on the registry are indexed under De Quervain Disease; 7 are open to participants now.
This study's planned enrollment of 60 is close to the median of 55 across 26 interventional studies indexed under De Quervain Disease.
Browse De Quervain Disease studies →Cairo University is the lead sponsor of 4,941 studies on the registry; 1,457 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
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:
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.
Time frame: Up to Four weeks
Ultrasonographic Changes: Color Doppler activity
Ultrasonography
Time frame: Up to Four weeks
Pain intensity level assessment :
VAS will be used by the patient to mark his/her level of pain on visual analogue scale.
Time frame: 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.
Time frame: 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).
Time frame: Up to Four weeks
Pinch grip Strength assessment:
The key pinch will be tested with a Baseline hydraulic pinch gauge (Baseline®, Irvington, NY, USA)
Time frame: Up to Four weeks
Start is estimated for Apr 2023; primary completion for Apr 2024, 12 months later.
Of 16 interventional studies with no phase under De Quervain Disease, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 28. This study's planned 12 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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