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

NCT06692998 | Not Yet Recruiting

• 1 other identifier: SADEQ
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

DeQuervain Tendinopathy

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Disabilities of the Arm, Shoulder and Hand Questionnaire (QUICK DASH)

  Before treatment (T0), After tratment (3. week) (T1)

• Ultrasonographic evaluation

  Before treatment (T0), After tratment (3. week) (T1)

Study Arms (2)

HILT Group

EXPERIMENTAL

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

LLLT Group

ACTIVE COMPARATOR

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

Interventions

Rehabilitation 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.

HILT Group; LLLT Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Afyonkarahisar Health Sciences University: lead

MeSH Terms

Interventions

Rehabilitation

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• SEVDA ADAR, Ass. Prof.

  Afyonkarahisar Health Sciences University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

SEVDA ADAR, Ass. Prof.

CONTACT

+905325940725; drsevdaadar@gmail.com

Study Design

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

Study Record Dates

• First Submitted: November 15, 2024
• First Posted: November 18, 2024
• Study Start: December 1, 2024
• Primary Completion: September 1, 2025
• Study Completion: December 1, 2025
• Last Updated: November 21, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share