ClinicalTrials.gg
RecruitingNCT07256522Updated Mar 19, 2026

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

An interventional study of Finger orthosis and Paraffin bath in Trigger Finger, Splint Therapy and Paraffin Bath, sponsored by Konya Beyhekim Training and Research Hospital. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-03-19.

Sponsored by Konya Beyhekim Training and Research Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Dec 2025; still recruiting 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

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

Keywords

  • trigger finger
  • splint therapy
  • paraffin bath
  • peloidotherapy
  • Randomised Controlled Study
03

In context

Trigger Finger Disorder

93 studies on the registry are indexed under Trigger Finger Disorder; 22 are open to participants now.

This study's planned enrollment of 60 is close to the median of 66 across 75 interventional studies indexed under Trigger Finger Disorder.

Browse Trigger Finger Disorder studies →

Lead sponsor

Konya Beyhekim Training and Research Hospital is the lead sponsor of 32 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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.

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

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 or nonsteroidal anti-inflammatory drugs (NSAIDs)
  • Patients with inflammatory or 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
Terms in these criteria, in plain language(2)

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.

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.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Finger orthosis

    The group receiving the finger joint-blocking orthosis

    Device: Finger orthosis

  • Experimental
    Paraffin bath

    The group receiving paraffin bath therapy

    Other: Paraffin bath

  • Experimental
    Peloidotherapy

    The group receiving peloidotherapy

    Other: Peloidotherapy

Interventions

  • DeviceFinger orthosis

    Joint-blocking finger orthosis plus home-based exercise therapy

  • OtherParaffin bath

    Paraffin bath plus home-based exercise therapy

  • OtherPeloidotherapy

    Peloidotherapy plus home-based exercise therapy

06

What researchers measure

Primary outcomes

  1. VAS pain

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

    Time frame: Baseline, week 3 and week 6

  2. 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.

    Time frame: Baseline, week 2 and week 6

  3. 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

    Time frame: Baseline, week 2 and week 6

Secondary outcomes

  1. Patient Global Impression of Change

    Patient Global Impression of Change (Improvement): 1: Very much improved 2: Much improved 3: Minimally improved 4: No change 5: Minimally worse 6: Much worse 7: Very much worse

    Time frame: Week 2 and week 6

  2. Ultrasonographic evaluation of the trigger finger

    Ultrasonographic evaluation of the trigger finger will be performed using a LA2-14A transducer. The hand and forearm will be positioned with the palmar surface facing upward (full supination) and the wrist maintained in a neutral position. The ultrasound examination will begin in the longitudinal plane and then proceed to the transverse plane. The MCP joint, flexor tendons, and volar will be identified. At the level of the MCP joint, the transducer will be rotated to obtain a transverse image along the long axis of the flexor digitorum tendons. The thin layer located between the hyperechoic A1 pulley and the hyperechoic surface of the flexor digitorum tendons will represent the synovial fluid space, appearing as a hypoechoic band on ultrasonography. The thickness of the A1 pulley will be defined as the distance between its superior and inferior margins, including the hyperechoic region. The maximum thickness of the A1 pulley above the MCP joint will be measured and recorded.

    Time frame: Baseline, week 2 and week 6

  3. Ultrasonographic evaluation of the trigger finger

    The cross-sectional areas (CSAs) of the flexor digitorum tendons will also be measured using a similar approach as described above. At the level of the MCP joint, the maximum CSAs of the flexor digitorum tendons will be manually traced in the transverse view along the outer hyperechoic contour. The average of three measurements will be calculated and recorded. Similar measurements will be performed on the corresponding finger of the contralateral healthy hand and recorded for comparison.

    Time frame: Baseline, week 2 and week 6

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 19, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07256522
Lead sponsor
Konya Beyhekim Training and Research Hospital
Responsible party
Ramazan Yılmaz, MD (Associate Prof (MD), Konya Beyhekim Training and Research Hospital) — Principal investigator
First posted
Dec 1, 2025
Start date
Dec 15, 2025
Primary completion
Jan 15, 2027 (estimated)
Completion
Feb 15, 2027 (estimated)
Last update
Mar 19, 2026

Study contacts

Ramazan Yilmaz, Assoc Prof (MD)
Contact
drramazanyilmaz@yahoo.com
+905556232674
Ramazan Yilmaz, Assoc Prof
principal investigator · Konya Beyhekim Training and Research Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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