Low-Level Laser Therapy in the Treatment of Trigger Finger
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDokuz Eylul University
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Low Level Laser Therapy
DeviceLow-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 Therapy
DeviceSham 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.
Treatment groups
91 Participants
are divided into 2 treatment groupsGroup A: Low Level Laser TherapyExperimental treatment 1 intervention
Group B: Sham Low Level Laser TherapySham comparator 1 intervention
Trial outcomes
Primary outcomes
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.
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.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.
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.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.
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.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).
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.Secondary outcomes
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.
Time frame
All participants will be assessed at three time points: at baseline, immediately after completion of treatment, and 1 month after treatment2
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.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.
Time frame
All participants will be assessed at three time points: at baseline, immediately after completion of treatment, and 1 month after treatment4
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.Sponsors and contacts
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Source ClinicalTrials.gov