An interventional study of Low Level Laser Therapy and Sham Low Level Laser Therapy in Trigger Finger, Stenosing Tenosynovitis and Trigger Digit, sponsored by Dokuz Eylul University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-30.
Sponsored by Dokuz Eylul University · Not applicable, Interventional, and Treatment
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.
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.
93 studies on the registry are indexed under Trigger Finger Disorder; 22 are open to participants now.
This study's planned enrollment of 91 is above the median of 66 across 75 interventional studies indexed under Trigger Finger Disorder.
Browse Trigger Finger Disorder studies →Dokuz Eylul University is the lead sponsor of 261 studies on the registry; 35 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
Also known as: 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.
Also known as: Sham Low Level Laser Treatment
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.
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.
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.
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.
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.
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.
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).
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.
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.
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
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.
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
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.
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
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.
Time frame: All participants will be assessed at three time points: at baseline, immediately after completion of treatment, and 1 month after treatment.
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.
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.
Plan to share: No
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Started Aug 2025 (actual). Primary completion is estimated for Dec 2026, 16 months after the start.
Of 34 interventional studies with no phase under Trigger Finger Disorder, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 41. This study's planned 16 months is below that.
Primary completion moved once since we started tracking on Sep 25, 2026: Aug 2026 → Dec 2026, on Sep 30, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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