Trigger FingerNCT07256522
Comparative Evaluation of Finger Splint, Paraffin, and Peloidotherapy Interventions in the Management of Trigger Finger
A study testing Finger orthosis, Paraffin bath and Peloidotherapy in people with Trigger Finger and Splint Therapy, run by Konya Beyhekim Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Trigger Finger, Splint Therapy, Paraffin Bath
- What is being tested?
- Finger orthosis, Paraffin bath and Peloidotherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Dec 2025to 15 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Konya Beyhekim Training and Research Hospital
Konya, Konya, 42080
Ramazan Yilmaz, Assoc Prof, +905556232674, drramazanyilmaz@yahoo.com
About this study
Official title: Comparative Evaluation of Finger Splint, Paraffin, and Peloidotherapy Interventions in the Management of Trigger Finger. A Prospective, Randomized, Controlled Study
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.
- Conditions
- Trigger Finger, Splint Therapy, Paraffin Bath, Peloidotherapy, Efficacy and Safety, Randomised Clinical Trial
- Being tested
- Finger orthosis, Paraffin bath, Peloidotherapy
- Keywords
- trigger finger, splint therapy, paraffin bath, peloidotherapy, Randomised Controlled Study
- Medical subject headings
- Trigger Finger Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Finger orthosisDevice
Joint-blocking finger orthosis plus home-based exercise therapy
Paraffin bathOther
Paraffin bath plus home-based exercise therapy
PeloidotherapyOther
Peloidotherapy plus home-based exercise therapy
| Study group | Role | What they receive |
|---|---|---|
| Finger orthosis | Experimental | The group receiving the finger joint-blocking orthosis Receives: Device: Finger orthosis |
| Paraffin bath | Experimental | The group receiving paraffin bath therapy Receives: Other: Paraffin bath |
| Peloidotherapy | Experimental | The group receiving peloidotherapy Receives: Other: Peloidotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS pain
VAS pain: 0 no pain; 10 unbearable/max. pain.
Measured: 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.
Measured: 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
Measured: Baseline, week 2 and week 6
Secondary outcomes (3)
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
Measured: 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.
Measured: 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.
Measured: Baseline, week 2 and week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2025
- Study start15 Dec 2025
- Primary completion15 Jan 2027 (estimated)
- Study completion15 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trigger FingerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Konya Beyhekim Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ramazan Yılmaz, MD, Konya Beyhekim Training and Research Hospital
- Investigators
- Ramazan Yilmaz, Assoc Prof, Principal investigator, Konya Beyhekim Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07256522
- Sponsor's protocol ID
- KonyaBeyhekimTRH2025/5634
- Status last verified
- Nov 2025
- First submitted
- 20 Nov 2025
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Finger Splint, Paraffin, and Peloidotherapy Interventions in the Management of Trigger Finger. A Prospective, Randomized, Controlled Study
- ClinicalTrials.gov ID
- NCT07256522
- Acronym / sponsor ID
- KonyaBeyhekimTRH2025/5634
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Konya Beyhekim Training and Research HospitalOther government
- Study start
- 15 Dec 2025 (actual)
- Primary completion
- 15 Jan 2027 (estimated)
- Study completion
- 15 Feb 2027 (estimated)
- First posted
- 1 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Finger orthosis | Experimental | Device: Finger orthosisThe group receiving the finger joint-blocking orthosis |
| Paraffin bath | Experimental | Other: Paraffin bathThe group receiving paraffin bath therapy |
| Peloidotherapy | Experimental | Other: PeloidotherapyThe group receiving peloidotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Finger orthosisJoint-blocking finger orthosis plus home-based exercise therapy | Device | Finger orthosis |
| Paraffin bathParaffin bath plus home-based exercise therapy | Other | Paraffin bath |
| PeloidotherapyPeloidotherapy plus home-based exercise therapy | Other | Peloidotherapy |
Primary outcome
VAS pain
Time frame: Baseline, week 3 and week 6
VAS pain: 0 no pain; 10 unbearable/max. pain.
Green's classification (Grades 1-4)
Time frame: Baseline, week 2 and week 6
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.
Michigan Hand Outcomes Questionnaire (MHQ)
Time frame: Baseline, week 2 and week 6
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
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ramazan Yilmaz, Assoc Prof principal investigator
Konya Beyhekim Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Finger orthosis, Paraffin bath and Peloidotherapy in people with Trigger Finger and Splint Therapy, run by Konya Beyhekim Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ramazan Yilmaz, Assoc Prof (MD) (+905556232674, drramazanyilmaz@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS pain (time frame: Baseline, week 3 and week 6). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.