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Clinical Trial NCT07256522 for Trigger Finger, Splint Therapy, Paraffin Bath, Peloidotherapy, Efficacy and Safety, Randomised Clinical Trial is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Comparative Evaluation of Finger Splint, Paraffin, and Peloidotherapy Interventions in the Management of Trigger Finger 60 Exercise-Based
Clinical Trial NCT07256522 is an interventional study for Trigger Finger, Splint Therapy, Paraffin Bath, Peloidotherapy, Efficacy and Safety, Randomised Clinical Trial that is recruiting. It started on 15 December 2025 with plans to enroll 60 participants. Led by Konya Beyhekim Training and Research Hospital, it is expected to complete by 15 February 2027. The latest data from ClinicalTrials.gov was last updated on 19 March 2026.
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 ...Show More
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 wil...Show More
Official Title
Comparative Evaluation of Finger Splint, Paraffin, and Peloidotherapy Interventions in the Management of Trigger Finger. A Prospective, Randomized, Controlled Study
Conditions
Trigger FingerSplint TherapyParaffin BathPeloidotherapyEfficacy and SafetyRandomised Clinical TrialOther Study IDs
- KonyaBeyhekimTRH2025/5634
NCT ID Number
Start Date (Actual)
2025-12-15
Last Update Posted
2026-03-19
Completion Date (Estimated)
2027-02-15
Enrollment (Estimated)
60
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
trigger finger
splint therapy
paraffin bath
peloidotherapy
Randomised Controlled Study
splint therapy
paraffin bath
peloidotherapy
Randomised Controlled Study
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Double
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalFinger orthosis The group receiving the finger joint-blocking orthosis | Finger orthosis Joint-blocking finger orthosis plus home-based exercise therapy |
ExperimentalParaffin bath The group receiving paraffin bath therapy | Paraffin Bath Paraffin bath plus home-based exercise therapy |
ExperimentalPeloidotherapy The group receiving peloidotherapy | Peloidotherapy Peloidotherapy plus home-based exercise therapy |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 | Week 2 and week 6 |
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. | Baseline, week 2 and week 6 |
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. | Baseline, week 2 and week 6 |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- 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
- 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
Study Responsible Party
Ramazan Yılmaz, MD, Principal Investigator, Associate Prof (MD), Konya Beyhekim Training and Research Hospital
Study Central Contact
Contact: Ramazan Yilmaz, Assoc Prof (MD), +905556232674, [email protected]
1 Study Locations in 1 Countries
Konya
Konya Beyhekim Training and Research Hospital, Konya, Konya, 42080, Turkey (Türkiye)
Ramazan Yilmaz, Assoc Prof, Contact, +905556232674, [email protected]
Recruiting