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

NCT07256522 | Recruiting

• 1 other identifier: KonyaBeyhekimTRH2025/5634
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Trigger Finger; Splint Therapy; Paraffin Bath; Peloidotherapy; Efficacy and Safety; Randomised Clinical Trial

Keywords

trigger finger; splint therapy; paraffin bath; peloidotherapy; Randomised Controlled Study

Outcome Measures

Primary Outcomes (3)

• VAS pain

  VAS pain: 0 no pain; 10 unbearable/max. pain.

  Baseline, week 3 and week 6

• Green's classification (Grades 1-4)

  Trigger finger classified according to Green's classification (Grades 1-4) Grade 1 - Pretriggering: Pain in the palm and tenderness over the A1 pulley, with a history of triggering not demonstrable on examination. Grade 2 - Active Triggering: Triggering is clinically evident, but the patient can actively extend the finger. Grade 3 - Passive Triggering: 3a: Locking is present and requires passive extension. 3b: Locking is present, and the patient cannot actively flex the finger. Grade 4 - Contracture: The finger is completely locked with a fixed flexion contracture at the PIP joint.

  Baseline, week 2 and week 6

• Michigan Hand Outcomes Questionnaire (MHQ)

  The Michigan Hand Outcomes Questionnaire (MHQ) is a comprehensive self-reported questionnaire developed to evaluate hand function, pain, and patient satisfaction. It is used to assess the functional status of individuals with upper extremity disorders and consists of six subscales: Overall Hand Function, Activities of Daily Living, Work Performance, Pain, Aesthetics, and Satisfaction. The Turkish version of the MHQ has undergone linguistic and cultural adaptation processes, and its validity and reliability have been established. Studies have demonstrated that the Turkish MHQ has high internal consistency and test-retest reliability, supporting its use in both clinical practice and research for assessing hand and wrist problems. The MHQ is scored on a scale ranging from 1 to 100. Except for the pain subscale, higher scores indicate better hand function and satisfaction, whereas higher pain scores represent greater pain intensity. The overall hand health status is determined by cal

  Baseline, week 2 and week 6

Secondary Outcomes (3)

• Patient Global Impression of Change

  Week 2 and week 6

• Ultrasonographic evaluation of the trigger finger

  Baseline, week 2 and week 6

• Ultrasonographic evaluation of the trigger finger

  Baseline, week 2 and week 6

Study Arms (3)

Finger orthosis

EXPERIMENTAL

The group receiving the finger joint-blocking orthosis

Device: Finger orthosis

Paraffin bath

EXPERIMENTAL

The group receiving paraffin bath therapy

Other: Paraffin bath

Peloidotherapy

EXPERIMENTAL

The group receiving peloidotherapy

Other: Peloidotherapy

Interventions

Finger orthosis DEVICE

Joint-blocking finger orthosis plus home-based exercise therapy

Finger orthosis

Paraffin bath OTHER

Paraffin bath plus home-based exercise therapy

Paraffin bath

Peloidotherapy OTHER

Peloidotherapy plus home-based exercise therapy

Peloidotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Konya Beyhekim Training and Research Hospital: lead

Study Sites (1)

Konya Beyhekim Training and Research Hospital

Konya, Konya, 42080, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Trigger Finger Disorder

Condition Hierarchy (Ancestors)

Tendon Entrapment; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases

Study Officials

• Ramazan Yilmaz, Assoc Prof

  Konya Beyhekim Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ramazan Yilmaz, Assoc Prof (MD)

CONTACT

+905556232674; drramazanyilmaz@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: single blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Prof (MD)

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 1, 2025
• Study Start: December 15, 2025
• Primary Completion (Estimated): January 15, 2027
• Study Completion (Estimated): February 15, 2027
• Last Updated: March 19, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)