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Effectiveness of High-intensity Laser Therapy in De Quervain Tenosynovitis

Primary Purpose

De Quervain Disease

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
high intensity laser therapy
Sponsored by
Kirsehir Ahi Evran University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for De Quervain Disease focused on measuring Hand grip strength, high-intensity laser therapy, De Quervain Disease

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Private Medar Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

high-intensity laser therapy (HILT)

sham HILT

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
November 19, 2021
Last Updated
August 4, 2022
Sponsor
Kirsehir Ahi Evran University
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1. Study Identification

Unique Protocol Identification Number
NCT05141799
Brief Title
Effectiveness of High-intensity Laser Therapy in De Quervain Tenosynovitis
Official Title
Effectiveness of High-intensity Laser Therapy in De Quervain Tenosynovitis; a Prospective, Randomized, Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
March 11, 2022 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kirsehir Ahi Evran University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
De Quervain Disease
Keywords
Hand grip strength, high-intensity laser therapy, De Quervain Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
high-intensity laser therapy (HILT)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
sham HILT
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
high intensity laser therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
quick Disabilities of the Arm, Shoulder, and Hand (QDASH) questionnaire
Description
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.
Time Frame
5 Minutes
Title
JAMAR hydraulic hand dynamometer
Description
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.
Time Frame
2 minutes
Secondary Outcome Measure Information:
Title
visual analog scale (VAS)
Description
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.
Time Frame
10 Seconds

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emine Dundar Ahi, assist prof
Organizational Affiliation
Kirsehir Ahi Evran University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Private Medar Hospital
City
Kocaeli
State/Province
Golcuk
ZIP/Postal Code
41650
Country
Turkey

12. IPD Sharing Statement

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Effectiveness of High-intensity Laser Therapy in De Quervain Tenosynovitis

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