Effectiveness of High-intensity Laser Therapy in De Quervain Tenosynovitis

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

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.

Study Overview

• Status: Completed
• Conditions: De Quervain Disease
• Intervention / Treatment: Device: high intensity laser therapy

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Golcuk
    • Kocaeli, Golcuk, Turkey, 41650
      • Private Medar Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: high-intensity laser therapy (HILT); we will apply the HILT device to the most painful area of the wrist in two phases. In both phase I and phase II, the laser will be applied using continuous circular movements. The first three sessions (phase I) will be used to provide analgesic effects at an intermittent phase, applying a 75 sec, 8 W, 6 J/cm2 treatment for a total of 150 J of energy. The subsequent six sessions (phase II) will provide a biostimulatory effect at a continuous phase, applying a 30 sec, 6 W, 120 to 150 J/cm2 treatment. The HILT will be applied for a total of nine treatment sessions over a period of three consecutive weeks.	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.
Sham Comparator: sham HILT; We will apply the HILT device to the most painful area of the wrist by using continuous circular movements, but the laser instrument will switched off during applications. The sham HILT will be applied for a total of nine treatment sessions over a period of three consecutive weeks.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Kocaeli University
• Investigators: Principal Investigator: Emine Dundar Ahi, assist prof, Kocaeli University

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2022
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: November 19, 2021
• First Submitted That Met QC Criteria: November 19, 2021
• First Posted (Actual): December 2, 2021

Study Record Updates

• Last Update Posted (Actual): August 5, 2022
• Last Update Submitted That Met QC Criteria: August 4, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Hand grip strength; high-intensity laser therapy; De Quervain Disease
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Muscular Diseases; Tendinopathy; Tendon Entrapment; Tenosynovitis; De Quervain Disease
• Other Study ID Numbers: 2/2020.K-061

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No