DeQuervain TendinopathyNCT06692998
High and Low Level Laser Therapy in De Quervain's Tenosynovitis
A study testing Rehabilitation in people with DeQuervain Tendinopathy, run by Afyonkarahisar Health Sciences University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- DeQuervain Tendinopathy
- What is being tested?
- Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2024to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between18-65 years of age
- Wrist pain for more than 3 weeks
- Finkelstein test positive
- Ability to understand commands
Who cannot join
- 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
Show all 9Show fewer
- Pregnancy or planning pregnancy during treatment
- Malignancy
- Pathology in the wrist on radiograph
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Afyonkarahisar Health Sciences University Health Application and Research Center Physical Medicine and Rehabilitation Clinic
Afyonkarahisar
About this study
Official title: 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.
Read the 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
- Being tested
- Rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RehabilitationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Other: Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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'.
Measured: Before treatment (T0), After tratment (3. week) (T1)
Secondary outcomes (2)
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).
Measured: Before treatment (T0), After tratment (3. week) (T1)
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.
Measured: Before treatment (T0), After tratment (3. week) (T1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2024
- Study start1 Dec 2024
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeQuervain TendinopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Afyonkarahisar Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sevda Adar, Afyonkarahisar Health Sciences University
- Investigators
- SEVDA ADAR, Ass. Prof., Principal investigator, Afyonkarahisar Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06692998
- Sponsor's protocol ID
- SADEQ
- Status last verified
- Jul 2026
- First submitted
- 15 Nov 2024
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of High and Low Level Laser Therapy in the Treatment of De Quervain's Tenosynovitis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06692998
- Acronym / sponsor ID
- SADEQ
- Conditions
- DeQuervain Tendinopathy
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Afyonkarahisar Health Sciences UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 18 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HILT Group | Experimental | Other: RehabilitationPatients 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. |
| LLLT Group | Active comparator | Other: RehabilitationThe 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Between18-65 years of age
- Wrist pain for more than 3 weeks
- Finkelstein test positive
- Ability to understand commands
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RehabilitationPatients 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. | Other | HILT Group, LLLT Group |
Primary outcome
Visual Pain Scale (VAS)
Time frame: Before treatment (T0), After tratment (3. week) (T1)
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.
Ritchie Articular Index
Time frame: Before treatment (T0), After tratment (3. week) (T1)
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.
Finkelstein test
Time frame: Before treatment (T0), After tratment (3. week) (T1)
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.
Jamar Dynamometer
Time frame: Before treatment (T0), After tratment (3. week) (T1)
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'.
2 secondary outcomes
Disabilities of the Arm, Shoulder and Hand Questionnaire (QUICK DASH)
Time frame: Before treatment (T0), After tratment (3. week) (T1)
Ultrasonographic evaluation
Time frame: Before treatment (T0), After tratment (3. week) (T1)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
SEVDA ADAR, Ass. Prof. principal investigator
Afyonkarahisar Health Sciences University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rehabilitation in people with DeQuervain Tendinopathy, run by Afyonkarahisar Health Sciences University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Pain Scale (VAS) (time frame: Before treatment (T0), After tratment (3. week) (T1)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.