Low-Level Laser Therapy in the Treatment of Trigger Finger

August 4, 2026 updated by: Nihan ERDINC GUNDUZ, Dokuz Eylul University

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.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
91

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Low Level Laser Therapy
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.
Device: Low Level Laser Therapy

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.

Other Names:
  • Low Level Laser Treatment
Sham Comparator: Sham Low Level Laser Therapy
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.
Device: Sham Low Level Laser Therapy

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.

Other Names:
  • Sham Low Level Laser Treatment

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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.
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.
Quinnell Classification
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 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.
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.
Trigger Finger Assessment 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 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.
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.
Number of Triggering Events During 10 Active Full Fist Movements
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 number of triggering events during 10 consecutive active full fist movements will be recorded (0-10).
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH)
Time Frame: All participants will be assessed at three time points: at baseline, immediately after completion of treatment, and 1 month after treatment
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.
All participants will be assessed at three time points: at baseline, immediately after completion of treatment, and 1 month after treatment
Hand Grip Strength
Time Frame: All participants will be assessed at three time points: at baseline, immediately after completion of treatment, and 1 month after treatment.
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.
All participants will be assessed at three time points: at baseline, immediately after completion of treatment, and 1 month after treatment.
A1 Pulley Thickness
Time Frame: All participants will be assessed at three time points: at baseline, immediately after completion of treatment, and 1 month after treatment
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.
All participants will be assessed at three time points: at baseline, immediately after completion of treatment, and 1 month after treatment
Flexor Tendon Thickness
Time Frame: All participants will be assessed at three time points: at baseline, immediately after completion of treatment, and 1 month after treatment.

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.
All participants will be assessed at three time points: at baseline, immediately after completion of treatment, and 1 month after treatment.
Patient Satisfaction
Time Frame: All participants will be assessed at three time points: immediately after completion of treatment, 1 month after treatment, and 3 months after treatment.
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.
All participants will be assessed at three time points: immediately after completion of treatment, 1 month after treatment, and 3 months after treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dokuz Eylul University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Elif Akalın, Prof, MD, Dokuz Eylul University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 7, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 4, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 4, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 7, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 7, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2025/12-03

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings