Effectiveness of High-intensity Laser Therapy in De Quervain Tenosynovitis

NCT05141799 | Completed

• 1 other identifier: 2/2020.K-061
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

De Quervain Disease

Keywords

Hand grip strength; high-intensity laser therapy; De Quervain Disease

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• visual analog scale (VAS)

  10 Seconds

Study Arms (2)

high-intensity laser therapy (HILT)

ACTIVE COMPARATOR

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

sham HILT

SHAM COMPARATOR

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

Interventions

high intensity laser therapy DEVICE

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.

high-intensity laser therapy (HILT); sham HILT

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kocaeli University: lead

Study Sites (1)

Private Medar Hospital

Kocaeli, Golcuk, 41650, Turkey (Türkiye)

Location

MeSH Terms

Conditions

De Quervain Disease

Condition Hierarchy (Ancestors)

Tendon Entrapment; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases

Study Officials

• Emine Dundar Ahi, assist prof

  Kocaeli University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 19, 2021
• First Posted: December 2, 2021
• Study Start: March 11, 2022
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: August 5, 2022

Record last verified: 2022-08

Locations

TU (1)