Comparative Evaluation of Finger Splint, Paraffin, and Peloidotherapy Interventions in the Management of Trigger Finger

Official title

Comparative Evaluation of Finger Splint, Paraffin, and Peloidotherapy Interventions in the Management of Trigger Finger. A Prospective, Randomized, Controlled Study

Overview

Patients aged 18-75 years who present with trigger finger to a tertiary rehabilitation hospital and agree to participate will be included in the study. Participants will be randomly allocated into three groups using block randomization. The first group will use a static finger splint that blocks the proximal interphalangeal joint for 6 weeks, along with a home exercise program. The second group will receive paraffin bath therapy, and the third group will receive peloidotherapy, both in combination with home exercises. All patients will receive education about the disease and activity modification. The finger joint-restricting splint and exercises will be applied for 6 weeks. Evaluations will be conducted at baseline, at the end of the 3rd week, and at the end of the 6th week by a blinded assessor. No analgesic or anti-inflammatory medication will be permitted during the study, and patients will be instructed to avoid using analgesics within 24 hours prior to each assessment.

Detailed description

Patients aged between 18 and 75 years who were diagnosed with trigger finger and agreed to participate in the study will be included. A total of 60 patients who have applied to the Physical Medicine and Rehabilitation outpatient clinics of the University of Health Sciences Beyhekim Training and Research Hospital will be enrolled. According to the inclusion and exclusion criteria, eligible and willing participants will be randomly assigned to three groups using block randomization.

The first group will be instructed to use a static finger splint that blocks the proximal interphalangeal joint for 6 weeks and will also follow a home exercise program. The second group will receive paraffin bath therapy for 20 minutes per day, 15 sessions over 3 weeks, together with a home exercise program. The third group will receive peloidotherapy at 45°C for 20 minutes per day, consisting of 15 sessions over 3 weeks, in conjunction with a home exercise program.

A static finger splint that restricts the proximal interphalangeal joint and maintains it in extension will be provided to the patients. They will be instructed to wear the splint continuously during both day and night, removing it only for hygiene or essential needs. The splint will be worn for 6 weeks until the completion of the study, and the daily duration of splint use will be recorded for each patient.

The home exercise program will include finger passive and active range of motion exercises (passive fist-making and active range of motion without triggering), tendon gliding, self-administered gentle A1 pulley stretching, and gentle deep circular massage. The exercises will be demonstrated to each patient in practice by a physician or physiotherapist and taught using printed visual materials. Patients will be specifically instructed, encouraged, and monitored to ensure exercise adherence. Those with an adherence rate below 70-75% will be excluded from the study.

All patients will receive education about the disease and will be advised on activity modification. Evaluations will be performed before treatment, at the end of the 3rd week, and at the end of the 6th week. A blinded assessor will conduct detailed examinations and evaluate the groups in terms of the study's primary and secondary outcome measures.

Patients' baseline sociodemographic and clinical data will be recorded, and a detailed physical examination will be performed. Pain intensity, trigger frequency, severity, and functional impact will be evaluated using a 0-10 Visual Analog Scale (VAS). Clinical staging of the trigger finger will be determined according to Green's classification (Grades 1-4). Patient compliance with orthotic use and exercise will be documented. Ultrasound assessments, including tendons thickness, A1 pulley thickness, and the presence of effusion (semiquantitative) will be performed by a blinded researcher with over five years of experience in musculoskeletal ultrasonography. In addition, patients' satisfaction levels will be evaluated and recorded using the Patient Global Improvement Scale. Any potential treatment-related undesirable effects effects will also be documented.

No analgesic or anti-inflammatory medication will be prescribed during the treatment period. Additionally, patients will be informed not to take any analgesic medication within 24 hours before the assessments.

Interventions

• Device Finger orthosis
  Joint-blocking finger orthosis plus home-based exercise therapy
• Other Paraffin bath
  Paraffin bath plus home-based exercise therapy
• Other Peloidotherapy
  Peloidotherapy plus home-based exercise therapy

Primary outcome measures

• VAS pain [Time frame: Baseline, week 3 and week 6]
• Green's classification (Grades 1-4) [Time frame: Baseline, week 2 and week 6]
• Michigan Hand Outcomes Questionnaire (MHQ) [Time frame: Baseline, week 2 and week 6]

Secondary outcome measures (3)

• Patient Global Impression of Change [Time frame: Week 2 and week 6]
• Ultrasonographic evaluation of the trigger finger [Time frame: Baseline, week 2 and week 6]
• Ultrasonographic evaluation of the trigger finger [Time frame: Baseline, week 2 and week 6]

Eligibility criteria

Inclusion criteria

• Being between 18 and 75 years of age and willing to participate in the study
• Having a diagnosis of idiopathic single trigger finger, Grade 2-3

Exclusion criteria

• Patients with triggering in more than one finger
• Patients with triggering at the A3 pulley or with Grade 1 or Grade 4 trigger finger
• Patients with thumb (pollex) trigger finger
• Patients who have undergone any injection or interventional procedure (release surgery) for trigger finger within the past 6 months
• Patients who have received physical therapy for the hand within the past 6 months
• Patients currently using corticosteroids or nonsteroidal anti-inflammatory drugs (NSAIDs)
• Patients with inflammatory or autoimmune rheumatologic diseases such as rheumatoid arthritis, systemic lupus erythematosus, gout, or psoriatic arthritis
• Patients with other musculoskeletal disorders (e.g., carpal tunnel syndrome, de Quervain's tenosynovitis, symptomatic hand osteoarthritis, or Dupuytren's contracture) or neurological diseases (e.g., stroke-related hemiparesis, spinal cord injury, brachial plexus injury, multiple sclerosis, or Parkinsonism) affecting the same hand
• Patients with musculoskeletal disorders causing pain and/or limitation in the proximal upper extremity on the affected side (e.g., periarthritis, lateral epicondylitis, mononeuropathy, or radiculopathy)
• Patients with significant metabolic diseases (e.g., hypothyroidism, Cushing's syndrome, or uncontrolled diabetes)
• Patients with any condition that may interfere with treatment, such as open wounds, rashes, local infections, or active malignant disease of the hand
• Patients with a history of hand trauma (chronic or repetitive)
• Patients unwilling to complete the self-assessment questionnaires either independently or with assistance
• Pregnant women

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Turkey (Türkiye) · 1 center

• Konya Beyhekim Training and Research Hospital — Konya

Identifiers

NCT: NCT07256522 · KonyaBeyhekimTRH2025/5634

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗