High and Low Level Laser Therapy in De Quervain's Tenosynovitis

Comparison of the Efficacy of High and Low Level Laser Therapy in the Treatment of De Quervain's Tenosynovitis: a Randomized Controlled Trial

The aim in this study was to compare the effects of high and low power laser treatments in the treatment of de Quervein tenosynovitis clinically and ultrasonographically.

Study Overview

• Status: Not yet recruiting
• Conditions: DeQuervain Tendinopathy
• Intervention / Treatment: Other: Rehabilitation

Detailed Description

De Quervain's tenosynovitis is tenosynovitis of the abductor pollicis longus (APL) and extensor pollicis brevis (EPB) tendons. Conservative management includes nonsteroidal anti-inflammatory drugs, wrist and thumb immobilization, ultrasound, and low-level laser therapy (LLLT). According to early literature, low-level laser therapy and ultrasound therapy appear to produce similar biological effects in reducing inflammation and promoting tissue healing.

In a study low-power laser therapy was found to be effective compared to placebo in de Quervain's tenosynovitis.

In a study of 35 female patients, low-power laser therapy (LLLT) combined with a thumb-supported splint was not superior to splint alone in patients with de Quervain's tenosynovitis.

In a more recent study low-power laser therapy was found to be similarly effective to ultrasound therapy.

The investigators found no studies in the literature on the effect of high-power laser therapy. The aim in this study was to compare the effects of high and low power laser treatments in the treatment of de Quervein tenosynovitis clinically and ultrasonographically.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: SEVDA ADAR, Ass. Prof.; Phone Number: +905325940725; Email: drsevdaadar@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Between18-65 years of age
• Wrist pain for more than 3 weeks
• Finkelstein test positive
• Ability to understand commands

Exclusion Criteria:

• Physical therapy, injections, or surgery in the upper extremity in the last 3 months
• Fracture or trauma in the upper extremity in the last 6 months
• Radiating pain due to cervical discopathy
• Infection, loss of sensation, metal implant in the treatment area
• Inflammatory rheumatic diseases
• NSAID use
• Pregnancy or planning pregnancy during treatment
• Malignancy
• Pathology in the wrist on radiograph

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HILT Group; Patients will receive pulsed laser therapy using the HIRO 3 device (ASA Laser, Arcugnano, Italy) five times a week for 3 weeks, one session per day for a total of 15 sessions. The HILT device offers pulsed emission (1064 nm), very high peak power (3 kW), high fluence (energy density 360-1780 mJ/cm2), short duration (120-150 μs), average power of 10.5 W, low frequency (10-40 Hz), duty cycle of approximately 0.1%, a 0.5 cm diameter probe and a spot size of 0.2 cm. A standard handpiece equipped with fixed spacers is used to maintain the same distance from the skin. The 3-stage treatment program is planned to be applied to the 1st CMC joint area in each session.	Other: Rehabilitation; Patients will do hand-wrist joint range of motion, stretching and strengthening exercises for 20 minutes once a day, under the supervision of the same physiotherapist.
Active Comparator: LLLT Group; The MLS Multiwave Locked System laser device will be used for the treatment (low level laser). The laser probe (1 cm in diameter) will be applied directly and perpendicularly and lightly in contact with the skin. LLLT for de quatrein will be applied twice per session. Once the probe will be held in contact with the skin (at the radial styloid) and the second time in scanning mode (approximately 1 inch long along the tendon sheath). The area to be treated will be divided into 1 cm square areas and the optimum anti-inflammatory dosage (3 J/cm) continuous output mode will be used	Other: Rehabilitation; Patients will do hand-wrist joint range of motion, stretching and strengthening exercises for 20 minutes once a day, under the supervision of the same physiotherapist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Pain Scale (VAS)	Visual Pain Scale (VAS), which is easy to understand, apply and interpret, and provides valid and reliable data in a short time, is the most commonly used method in clinics. With a 100 mm visual linear scale, the patient is told that there is no pain at point 0, and that the most severe pain they have ever felt at point 100, and the patient is asked to put a mark on the point corresponding to their pain.	Before treatment (T0), After tratment (3. week) (T1)
Ritchie Articular Index	It is an index developed for the numerical measurement of joint tenderness in patients with rheumatoid arthritis. It is the quantitative evaluation number of the patient's response to the discomfort experienced by the joint when exposed to pressure during passive movement of the joint. It is a 4-point scale; if there is no tenderness (0), the patient complains of pain (1), the patient complains of pain and is accompanied by patient irritation (2), and the patient withdraws with pain and irritation (3). As a result, the total score obtained by summing the clinical evaluation index items made with joint tenderness is recorded.	Before treatment (T0), After tratment (3. week) (T1)
Finkelstein test	The Finkelstein test is the occurrence of wrist pain at the level of the radial styloid during ulnar deviation of the wrist with the thumb flexed into the palm and covered with the remaining fingers.	Before treatment (T0), After tratment (3. week) (T1)
Jamar Dynamometer	Measurements will be made by sitting with the shoulder adducted and neutrally rotated, adjacent to the body, elbow 90 degrees flexed, wrist 0-30 degrees dorsiflexed and 0-15 degrees ulnar deviation, thumb up. Measurements will be repeated three times with 5-second intervals on the affected hand and the average of the three measurements will be recorded in kilograms. Finger grip strength will be assessed with the 'Jamar digital pinchmeter'.	Before treatment (T0), After tratment (3. week) (T1)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ultrasonographic evaluation	Ultrasonographic evaluation for both wrists will be performed by the same physiatrist who is unaware of the participant's clinical data and group distribution using the Esaote My Lab 70 Vision USG device with a 7.5 MHz linear probe. The combined thickness of the APL and EPB sheaths will be measured. In addition, the presence of fluid and Doppler activity around the tendon will be assessed. Patients are assessed in a sitting position with both forearms placed on the patient's lap/thigh in a mid-prone position. The scanned area will extend from a few centimeters proximal to the radial styloid to the insertion of the tendons of the first compartment (distal end of the proximal phalanx). Transverse scans will be obtained for measurement of the tendon sheath at the level of the radial styloid.	Before treatment (T0), After tratment (3. week) (T1)
Disabilities of the Arm, Shoulder and Hand Questionnaire (QUICK DASH)	It is used to measure physical function and symptoms in patients with upper extremity musculoskeletal disorders.The questionnaire consists of a disability/symptom scale (11 items) and two optional scales: work (four items) and sports/performing arts (four items). Each item on the disability/symptom scale asks about pain intensity, activity-related pain, tingling, weakness and stiffness, difficulty moving, physical activity due to upper extremity problems, and the impact of upper extremity problems on social activities, work and sleep. Responses are given on a one-to-five scale, with each question scored from 1 to 5. From the item scores, scale scores are calculated, ranging from 0 (no disability) to 100 (most severe disability).	Before treatment (T0), After tratment (3. week) (T1)

Collaborators and Investigators

• Sponsor: Afyonkarahisar Health Sciences University
• Investigators: Principal Investigator: SEVDA ADAR, Ass. Prof., Afyonkarahisar Health Sciences University

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2024
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: November 15, 2024
• First Submitted That Met QC Criteria: November 15, 2024
• First Posted (Actual): November 18, 2024

Study Record Updates

• Last Update Posted (Estimated): November 21, 2024
• Last Update Submitted That Met QC Criteria: November 20, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Muscular Diseases; Wounds and Injuries; Tendon Injuries; Tendon Entrapment; Tendinopathy; Tenosynovitis; De Quervain Disease
• Other Study ID Numbers: SADEQ

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No