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Trigger FingerNCT07753460

Low-Level Laser Therapy in the Treatment of Trigger Finger

A study testing Low Level Laser Therapy in people with Trigger Finger and Stenosing Tenosynovitis, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Trigger finger, also known as stenosing tenosynovitis, is one of the most common disorders affecting the hand. Its lifetime prevalence is 2-3%. Patients typically present with locking of the affected finger during flexion and painful catching during extension. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Low Level Laser Therapy
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
91 participants
Where
1 siteTurkey (Türkiye)
Study dates
7 Aug 2025to Dec 2026
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Applying to the outpatient clinic of the Department of Physical Medicine and Rehabilitation, Faculty of Medicine, Dokuz Eylül University
  • A clinical diagnosis of trigger finger based on typical pain and tenderness over the A1 pulley accompanied by triggering of the affected finger
  • Willingness to participate in the study

Who cannot join

  • Multiple trigger fingers in the same hand
  • Fixed deformity (Quinnell grade 4)
  • Splint treatment, physical therapy, or steroid injection for the affected trigger finger within the previous 6 months
  • Previous surgery for the affected trigger finger
  • Musculoskeletal disorders or peripheral nerve injury involving the ipsilateral upper extremity
  • Rheumatoid arthritis, carpal tunnel syndrome, Dupuytren disease, amyloidosis, or mucopolysaccharidosis
Show all 11Show fewer
  • Active infection, bleeding, skin lesions, or an implant at the treatment site
  • Radiotherapy within the previous 6 months
  • Photodermatosis, photosensitivity, or systemic lupus erythematosus
  • Pregnancy, epilepsy, coagulopathy, active malignancy, or the presence of a cardiac pacemaker
  • Cognitive impairment that precludes understanding of the study questionnaires.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Gözde Kırım Kaya, MD contact

+902324123951

gozde.kirimkaya@deu.edu.tr

Nihan Erdinç Gündüz, Ass. Prof. MD contact

+902324123952

nihan.erdincgunduz@deu.edu.tr

Turkey (Türkiye)1 site, 1 recruiting
  • Dokuz Eylul University

    Izmir, Balçova, 35330

    Gözde Kırım Kaya, MD, gozde.kirimkaya@deu.edu.tr

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: Effectiveness of Low-Level Laser Therapy for Trigger Finger: A Randomized Double-Blind Sham-Controlled Trial

Trigger finger, also known as stenosing tenosynovitis, is one of the most common disorders affecting the hand. Its lifetime prevalence is 2-3%. Patients typically present with locking of the affected finger during flexion and painful catching during extension. In mild cases, pain, swelling, and morning stiffness may be present without triggering. In more severe cases, the affected finger may become locked in flexion.

Conservative treatment methods, corticosteroid injections, and surgical interventions can be used in the treatment of trigger finger. Conservative treatment options include activity modification, splint immobilization, exercise programs, massage, physical therapy modalities including extracorporeal shock wave therapy and therapeutic ultrasound, and nonsteroidal anti-inflammatory drugs (NSAIDs). Splinting is an inexpensive and effective treatment option for trigger finger.

Read more

Low-level laser therapy (LLLT) is a treatment modality based on photobiomodulation, which leads to biological changes in living organisms through the interaction of photons with atoms or molecules. LLLT is used to promote wound healing and tissue repair, prevent tissue damage, reduce inflammation and edema, and provide analgesia. Several studies have demonstrated the effectiveness of LLLT in the treatment of various musculoskeletal disorders.

This study aims to investigate the effects of adding active LLLT to splint treatment in patients with trigger finger. Patients receiving active LLLT plus splint treatment will be compared with those receiving sham LLLT plus splint treatment in terms of clinical and ultrasonographic outcomes.

Read the detailed description

Trigger finger develops as a result of a size mismatch between the flexor tendon or tendon sheath and the first annular (A1) pulley at the level of the metacarpal head. Although the A1 pulley is the most commonly affected site, triggering may also occur at the second and third annular pulleys (A2 and A3). The diagnosis of trigger finger is made clinically. Musculoskeletal ultrasonography is an adjunctive imaging modality that is increasingly used in the diagnosis of trigger finger. The ultrasonographic findings of trigger finger may include diffuse or nodular hypoechoic thickening of the A1 pulley and increased flexor tendon thickness.

Low-level laser therapy (LLLT) has been shown to be an effective, noninvasive treatment modality for pain reduction in various musculoskeletal disorders. Studies have investigated its effectiveness in the treatment of de Quervain's tenosynovitis, flexor tendon injuries, carpal tunnel syndrome, lateral epicondylitis, plantar fasciitis, and adhesive capsulitis. However, evidence evaluating the effectiveness of LLLT for the treatment of trigger finger remains limited. The literature includes a small, non-randomized, uncontrolled clinical study involving five patients. In addition, a case report described the application of a combination of LLLT, specific hand massage, and hand exercises in a patient with chronic trigger fingers and bilateral carpal tunnel syndrome. Although these studies reported favorable outcomes, high-quality evidence remains limited. To the best of our knowledge, no randomized controlled trials evaluating the use of LLLT for the treatment of trigger finger have been reported in the literature.

This study is a prospective, randomized, double-blind, sham-controlled clinical trial designed to investigate the effects of LLLT on clinical and ultrasonographic outcomes in patients with trigger finger. Adults with a clinical diagnosis of trigger finger who meet the eligibility criteria and provide written informed consent will be enrolled. Following randomization, participants will be assigned to either the active LLLT group or the sham LLLT group. Both groups will receive the same splint treatment during the intervention period. LLLT will be administered three times per week for 4 weeks, for a total of 12 treatment sessions, using a wavelength of 830 nm, an output power of 50 mW, continuous mode, and an energy density of 4 J/cm². Participants in the sham group will undergo the same treatment schedule, with the laser device remaining switched off throughout each session. To maintain participant blinding, participants in both groups will wear headphones and an eye mask during each treatment session. All participants will be provided with a metacarpophalangeal (MCP) joint blocking splint. The splint will block the MCP joint of the affected finger at 0° while allowing unrestricted movement of the interphalangeal joints. Participants will be instructed to wear the splint continuously for 4 weeks and to remove it only for personal hygiene. Compliance with splint use will be monitored using a daily diary in which participants will record the number of hours they wear the splint each day. The average daily wearing time will be calculated at the end of the treatment period. Participants will be allowed to continue their usual daily and work-related activities while avoiding movements that aggravate triggering symptoms or excessive use of the affected hand. Paracetamol will be permitted as rescue medication if needed, and its use will be recorded throughout the study.

Before treatment, demographic and clinical information, including age, sex, body mass index, affected hand, affected finger, symptom duration, and previous history of trigger finger, will be documented. Outcome measures will include pain intensity assessed with the Visual Analog Scale (VAS), triggering severity assessed with the Quinnell Classification, triggering frequency determined by the number of triggering events during 10 consecutive active full-fist movements, the Trigger Finger Assessment Scale (TFAS), the Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire, hand grip strength, patient satisfaction, and ultrasonographic measurements of A1 pulley thickness and flexor tendon thickness. Ultrasonographic assessments will be performed by a single experienced investigator, who will be blinded to treatment allocation. All clinical outcome assessments will also be conducted by an investigator blinded to treatment allocation.

Being tested
Low Level Laser Therapy, Sham Low Level Laser Therapy
Keywords
trigger finger, trigger digit, low level laser therapy, metacarpophalangeal joint blocking splint, stenosing tenosynovitis
Medical subject headings
Trigger Finger Disorder, Tendon Entrapment

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Low Level Laser TherapyDevice

    Also called Low Level Laser Treatment

    Low-level laser therapy will be administered three times per week for 4 weeks using a BTL-4000 Smart laser therapy device and the following treatment parameters: a wavelength of 830 nm, an output power of 50 mW, continuous mode, and an energy density of 4 J/cm².

    All participants will also receive a metacarpophalangeal joint blocking splint for 4 weeks.

  • Sham Low Level Laser TherapyDevice

    Also called Sham Low Level Laser Treatment

    Sham low-level laser therapy will be administered three times per week for 4 weeks, for a total of 12 sessions, using a BTL-4000 Smart laser therapy device that will remain switched off throughout each session. To maintain participant blinding, participants in both groups will wear headphones and an eye mask during each treatment session.

    All participants will also receive a metacarpophalangeal joint blocking splint for 4 weeks.

Study groups in NCT07753460
Study groupRoleWhat they receive
Low Level Laser TherapyExperimentalLow-level laser therapy will be administered three times per week for 4 weeks using a BTL-4000 Smart laser therapy device and the following treatment parameters: a wavelength of 830 nm, an output power of 50 mW, continuous mode, and an energy density of 4 J/cm².
Receives: Device: Low Level Laser Therapy
Sham Low Level Laser TherapySham comparatorSham low-level laser therapy will be administered three times per week for 4 weeks, for a total of 12 sessions, using a BTL-4000 Smart laser therapy device that will remain switched off throughout each session.
Receives: Device: Sham Low Level Laser Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Visual Analog Scale

    Changes in trigger finger pain will be assessed using the Visual Analog Scale. Scores range from 0 to 10 cm, with higher scores indicating greater pain intensity.

    Measured: All participants will be assessed at four time points: at baseline, immediately after completion of treatment, 1 month after treatment, and 3 months after treatment.

  2. Quinnell Classification

    The severity of triggering will be assessed using the Quinnell Classification: Grade 0, normal movement of the digit; Grade 1, uneven movement; Grade 2, actively correctable locking of the digit; Grade 3, passively correctable locking; and Grade 4, fixed deformity. Higher grades indicate greater triggering severity.

    Measured: All participants will be assessed at four time points: at baseline, immediately after completion of treatment, 1 month after treatment, and 3 months after treatment.

  3. Trigger Finger Assessment Scale

    The Trigger Finger Assessment Scale consists of three separate 0-to-10-point scales that assess the frequency, severity, and functional impact of triggering. Higher scores on each scale indicate more frequent or severe triggering or greater functional impact.

    Scale reference: Tarbhai K, Hannah S, von Schroeder HP. Trigger finger treatment: a comparison of 2 splint designs. J Hand Surg Am. 2012;37(2):243-249.

    Measured: All participants will be assessed at four time points: at baseline, immediately after completion of treatment, 1 month after treatment, and 3 months after treatment.

  4. Number of Triggering Events During 10 Active Full Fist Movements

    The number of triggering events during 10 consecutive active full fist movements will be recorded (0-10).

    Measured: All participants will be assessed at four time points: at baseline, immediately after completion of treatment, 1 month after treatment, and 3 months after treatment.

Secondary outcomes (5)
  1. Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH)

    The QuickDASH is an 11-item questionnaire used to assess physical function and symptoms. Each item is scored on a 5-point Likert scale, and the total score ranges from 0 to 100, with higher scores indicating greater disability.

    Measured: All participants will be assessed at three time points: at baseline, immediately after completion of treatment, and 1 month after treatment

  2. Hand Grip Strength

    Hand grip strength will be assessed using a Jamar hydraulic hand dynamometer. Three measurements will be performed on the affected hand, with a 1-minute rest interval between each measurement, and the mean of the three measurements will be recorded.

    Measured: All participants will be assessed at three time points: at baseline, immediately after completion of treatment, and 1 month after treatment.

  3. A1 Pulley Thickness

    A1 pulley thickness will be measured using ultrasonography in the longitudinal plane. The measurement will be taken at the thickest part of the A1 pulley.

    Measured: All participants will be assessed at three time points: at baseline, immediately after completion of treatment, and 1 month after treatment

  4. Flexor Tendon Thickness

    Flexor tendon thickness will be measured using ultrasonography in the longitudinal plane at three points:

    • A1 pulley tunnel inlet: metacarpal head-neck junction.
    • A1 pulley tunnel outlet: proximal phalangeal base-shaft junction.
    • A1 pulley tunnel (interpulley): middle of inlet and outlet.

    Reference: Chiang CH, Kuo LC, Kuo YL, Wu KC, Shao CJ, Chern TC, Jou IM. The value of high-frequency ultrasonographic imaging for quantifying trigger digits: a correlative study with clinical findings in patients with different severity grading. Ultrasound Med Biol. 2013;39(6):967-974.

    Measured: All participants will be assessed at three time points: at baseline, immediately after completion of treatment, and 1 month after treatment.

  5. Patient Satisfaction

    Patient satisfaction will be assessed using a 5-point scale with the following response options: completely satisfied, almost satisfied, moderately satisfied, somewhat satisfied, and dissatisfied.

    Measured: All participants will be assessed at three time points: immediately after completion of treatment, 1 month after treatment, and 3 months after treatment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Aug 2026
  2. Study start7 Aug 2025
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

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
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
91 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07753460
Sponsor's protocol ID
2025/12-03
Status last verified
Sep 2026
First submitted
4 Aug 2026
Last updated
30 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Low Level Laser Therapy in people with Trigger Finger and Stenosing Tenosynovitis, run by Dokuz Eylul 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 3 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 30 Sep 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. Some participants in this study may receive a placebo. 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?

Contact Gözde Kırım Kaya, MD (+902324123951, gozde.kirimkaya@deu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual Analog Scale (time frame: All participants will be assessed at four time points: at baseline, immediately after completion of treatment, 1 month after treatment, and 3 months after treatment.). 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 30 Sep 2026.

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