Clinical trial NCT05782114: 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
Overall status: UNKNOWN
Phase: NA
Conditions: De Quervain Disease
Keywords: Extracorporeal Shockwave therapy :ESWT
Ultrasonography US
HandGrip Strenght
De Quervain Tenosynovitis
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-03-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Extracorporeal Shockwave therapy \&Traditional physical therapy program
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Ultrasonographic Changes: Thickness in tendons:
timeFrame: Up to Four weeks
measure: Ultrasonographic Changes: Color Doppler activity
timeFrame: Up to Four weeks
Secondary outcomes:
measure: Pain intensity level assessment :
timeFrame: Up to Four weeks
measure: Assessment of upper limb function:
timeFrame: Up to Four weeks
measure: Handgrip Strength assessment:
timeFrame: Up to Four weeks
measure: Pinch grip Strength assessment:
timeFrame: Up to Four weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Mostafa Gomaa Mahmoud
Study officials:
affiliation: Profeesor of Basic Science / Faculty of Physical therapy/ Cairo university
name: Fatma S Amen
role: PRINCIPAL_INVESTIGATOR
affiliation: Assistant Prof. of Basic Science/ Faculty of Physical therapy/ Cairo university
name: Nabil M Ismail
role: PRINCIPAL_INVESTIGATOR
affiliation: Lecturer of Basic Science /Faculty of Physical therapy/ Cairo university
name: Doaa A Elimy
role: PRINCIPAL_INVESTIGATOR
affiliation: Lecturer of Radiology / Faculty of Medicine/ Beni Suef University
name: Ahmed S Abd El Basset
role: PRINCIPAL_INVESTIGATOR
References: