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

NCT ID: NCT06692998

Last Updated: 2024-11-21

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-01
• Study Completion Date: 2025-12-01

Brief Summary

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.

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.

Conditions

DeQuervain Tendinopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Rehabilitation

Intervention Type: OTHER

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.

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

Group Type: ACTIVE_COMPARATOR

Rehabilitation

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Afyonkarahisar Health Sciences University

OTHER

Sponsor Role: lead

Responsible Party

Sevda Adar

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

SEVDA ADAR, Ass. Prof.

Role: PRINCIPAL_INVESTIGATOR

Afyonkarahisar Health Sciences University

Central Contacts

SEVDA ADAR, Ass. Prof.

Role: CONTACT

drsevdaadar@gmail.com

+905325940725

Other Identifiers

SADEQ

Identifier Type: -

Identifier Source: org_study_id