Effectiveness of High-intensity Laser Therapy in De Quervain Tenosynovitis

De Quervain Disease Clinical Trial

Official title:

Effectiveness of High-intensity Laser Therapy in De Quervain Tenosynovitis; a Prospective, Randomized, Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05141799
• Other study ID #: 2/2020.K-061
• Status: Completed
• Phase: N/A
• Start date: March 11, 2022
• Est. completion date: June 30, 2022

Study information

• Verified date: August 2022
• Source: Kocaeli University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

68 De Quervain tenosynovitis(MPS) diagnosed patients will be randomly divided into 2 groups. To groups; splinting+exercise+high-intensity laser therapy (HILT) and splinting+exercise+sham HILT will be applied. Visual anolog scale (VAS) scores, quick Disabilities of the Arm, Shoulder, and Hand (QDASH) questionnaire and Hand grip strength measurements of the patients before-after treatment will be recorded and will be evaluated statistically.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• patients diagnosed with unilateral De Quervain tenosynovitis 18-65 years old

Exclusion Criteria:

• pain history of less than four weeks,

• upper extremity entrapment neuropathy,

• major psychiatric disease,

• upper extremity surgical treatment history,

• malignancy history,

• chronic rheumatic disease,

• cervical radiculopathy,

• cervical myelopathy,

• local corticosteroid injection prior to De Quervain tenosynovitis and receiving physical therapy.

Related Conditions & MeSH terms

• De Quervain Disease
• Tenosynovitis

Intervention

Device:
• high intensity laser therapy
Laser treatment is noninvasive and painless and can be easily administered in therapy units for a wide range of conditions. High-intensity laser therapy (HILT) has gained importance for the treatment of different kinds of sports injuries such as tendon injuries, contusions, and muscle spasms.

Locations

Country	Name	City	State
Turkey	Private Medar Hospital	Kocaeli	Golcuk

Sponsors (1)

Lead Sponsor	Collaborator
Kocaeli University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	quick Disabilities of the Arm, Shoulder, and Hand (QDASH) questionnaire	The QDASH is a self-reported questionnaire that measures the physical functions and symptoms of patients with upper limb problems. It includes 11 items from the DASH survey, and to calculate the QDASH score, atleast 10 of the 11 items should be answered. Each item contains five answer options, and the total score of the scale is calculated from the individual item scores (0=no disability and 100=the most serious disability). The first eight items of the QDASH questionnaire measure the patient's daily life function and social activity limitations. The ninth question assesses the pain intensity, and the 10th question evaluates the feeling of "pins and needles" in the upper extremity. The last question is designed to evaluate the sleep problem due to pain.	5 Minutes
Primary	JAMAR hydraulic hand dynamometer	Hand grip strength measurements will take with a JAMAR hydraulic hand dynamometer (Lafayette Instrument, Lafayette, IN, USA) are known to provide reliable results and these measurements will be obtain while the patient will stand with a full extension of the elbow and wrist. Each patient will be asked to squeeze the dynamometer with full force for a maximum of three seconds. First on the healthy side and then on the effected side, three measurements will be taken, and the averages will be obtain.	2 minutes
Secondary	visual analog scale (VAS)	Visual anolog scale (VAS) A Visual Analogue Scale (VAS) is a horizontal line, 100 mm in length measurement instrument that tries to measure the amount of pain that a patient feels ranges across a continuum from none to an extreme amount of pain.	10 Seconds