Trigger FingerNCT06382623
Efficacies of Different Managements in Patients With Trigger Finger
An observational study of Trigger Finger, run by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study is to compare the effectiveness of peritendinous steroid injection under ultrasound guidance and percutaneous A1 pulley release procedures in terms of disease stage, pain, and severity of locking in patients with trigger finger. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trigger Finger
- What is being tested?
- The percutaneous A1 pulley release and The peritendinous Betamethasone group
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2022to 30 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: older 18 ages
Who may be able to join
- Being over 18 years of age
- Having had trigger finger complaints for more than 1 month
- Not having received any injections for trigger finger diagnosis within the last 1 month
- Signing the informed consent form indicating willingness to participate in the study
Who cannot join
- Refusing to participate in the study
- Presence of partial or complete tendon rupture in the relevant tendon of the finger to be treated
- Presence of wounds and infection in the area where the procedure will be performed
- Pregnancy status
- History of allergy to the injected medications (local anesthetic, steroid)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Ankara
About this study
Official title: Comparing the Effectiveness of Peritendinous Steroid Injection Under Ultrasound Guidance With Percutaneous A1 Pulley Release in Trigger Finger Treatment
The aim of the study is to compare the effectiveness of peritendinous steroid injection under ultrasound guidance and percutaneous A1 pulley release procedures in terms of disease stage, pain, and severity of locking in patients with trigger finger.
Read the detailed description
This study was designed as a randomized, controlled, prospective study. Patients who had been experiencing trigger finger symptoms for at least one month and who presented to the Gaziler Physical Medicine and Rehabilitation Training and Research Hospital, affiliated with the Health Sciences University Faculty of Medicine
Patients were randomly divided into two groups: the peritendinous steroid group (n=15) and the percutaneous pulley release group (n=15). In the first group, under ultrasound guidance, a mixture of 1 ml corticosteroid (2 mg+5 mg/ml betamethasone) and 1 ml local anesthetic (20 ml 2% prilocaine) was injected peritendinously between the A1 pulley and the flexor tendon sheath. In the second group, a percutaneous A1 pulley release procedure was performed under ultrasound guidance using a 20 G needle, followed by peritendinous injection of the same mixture of corticosteroid and local anesthetic.
Patients were evaluated four times: before treatment, at 1 week, 1 month, and 3 months after treatment. Modified Quinnel classification, VAS (Visual Analog Scale), and severity of locking scales were used as outcome measures in the study.
- Conditions
- Trigger Finger
- Being tested
- The percutaneous A1 pulley release, The peritendinous Betamethasone group
- 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.
The percutaneous A1 pulley releaseProcedure or surgery
Ultrasound-guided percutaneous pulley release is a procedure aimed at loosening the pulley using various cutting instruments or hypodermic needles under ultrasound guidance.
The peritendinous Betamethasone groupOther
USG-guided injection of corticosteroid between the A1 pulley and the flexor tendon sheath.
| Study group | Role | What they receive |
|---|---|---|
| The peritendinous steroid group | A 1 ml mixture of corticosteroid (2 mg + 5 mg/ml betamethasone) and 1 ml of local anesthetic agent (20 ml 2% prilocaine) was injected peritendinously between the A1 pulley and the flexor tendon sheath at the metacarpophalangeal joint level under ultrasound guidance. Receives: Other: The peritendinous Betamethasone group | |
| The percutaneous A1 pulley release group | In the A1 pulley release group, 1 ml of local anesthetic agent (20 ml 2% prilocaine) was injected into the pulley-associated subcutaneous tissue using a 27 G needle under ultrasound guidance. The metacarpophalangeal joint was brought into slight hyperextension. Subsequently, a 20 G 0.9x38mm needle, modified by bending approximately 40-45 degrees from the proximal 1/3 of the needle with the aid of a cap, was used. The needle was advanced in-plane from distal to proximal along the midline, with simultaneous movement towards the palmar surface, aiming to cut or loosen the pulley between the tendon and A1 pulley. The loosening procedure was repeated from the distal to proximal aspect of the pulley until the sensation of resistance at the needle tip disappeared. Receives: Procedure: The percutaneous A1 pulley release |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stage of the disease
Modified Quinnel classification Stage 1: Normal movement, no pain.
- Stage 2: Normal movement, occasional pain.
- Stage 3: Irregular movement (catching without crepitus or locking).
- Stage 4: Locking present, actively correctable.
- Stage 5: Locking present, passively correctable.
Measured: first week, first mount, third month
Secondary outcomes (2)
Pain intensity
The pain associated with movement in the relevant finger was evaluated using the Visual Analog Scale (VAS). Patients were explained that "0" represented no pain at all, "10" represented the most severe pain they had ever experienced in their life, and "5" represented moderate pain. They were asked to indicate a number between 0 and 10 that corresponded to the intensity of pain they were feeling.
Measured: first week, first month, third month
severity of triggering
The severity of catching in patients was assessed using a Numeric Rating Scale (NRS) ranging from 0 to 10. Patients were explained that "0" represents no catching at all, while "10" represents catching requiring passive correction of the finger. They were asked to mark a number between 0 and 10 corresponding to the severity of catching they experienced.
Measured: first week, first month, third month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2024
- Study start1 Oct 2022
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasin Demir, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
- Investigators
- zeliha gizem mac, MD, Principal investigator, university of health sciences, Department of PM&R
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06382623
- Sponsor's protocol ID
- 43
- Status last verified
- Jun 2024
- First submitted
- 8 Apr 2024
- Last updated
- 6 Jun 2024
- Results posted
- 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 6 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Effectiveness of Peritendinous Steroid Injection Under Ultrasound Guidance With Percutaneous A1 Pulley Release in Trigger Finger Treatment
- ClinicalTrials.gov ID
- NCT06382623
- Acronym / sponsor ID
- 43
- Conditions
- Trigger Finger
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Gaziler Physical Medicine and Rehabilitation Education and Research HospitalUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 24 Apr 2024 (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.
The aim of the study is to compare the effectiveness of peritendinous steroid injection under ultrasound guidance and percutaneous A1 pulley release procedures in terms of disease stage, pain, and severity of locking in patients with trigger finger.
Detailed description
This study was designed as a randomized, controlled, prospective study. Patients who had been experiencing trigger finger symptoms for at least one month and who presented to the Gaziler Physical Medicine and Rehabilitation Training and Research Hospital, affiliated with the Health Sciences University Faculty of Medicine
Patients were randomly divided into two groups: the peritendinous steroid group (n=15) and the percutaneous pulley release group (n=15). In the first group, under ultrasound guidance, a mixture of 1 ml corticosteroid (2 mg+5 mg/ml betamethasone) and 1 ml local anesthetic (20 ml 2% prilocaine) was injected peritendinously between the A1 pulley and the flexor tendon sheath. In the second group, a percutaneous A1 pulley release procedure was performed under ultrasound guidance using a 20 G needle, followed by peritendinous injection of the same mixture of corticosteroid and local anesthetic.
Patients were evaluated four times: before treatment, at 1 week, 1 month, and 3 months after treatment. Modified Quinnel classification, VAS (Visual Analog Scale), and severity of locking scales were used as outcome measures in the study.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The peritendinous steroid group | – | Other: The peritendinous Betamethasone groupA 1 ml mixture of corticosteroid (2 mg + 5 mg/ml betamethasone) and 1 ml of local anesthetic agent (20 ml 2% prilocaine) was injected peritendinously between the A1 pulley and the flexor tendon sheath at the metacarpophalangeal joint level under ultrasound guidance. |
| The percutaneous A1 pulley release group | – | Procedure: The percutaneous A1 pulley releaseIn the A1 pulley release group, 1 ml of local anesthetic agent (20 ml 2% prilocaine) was injected into the pulley-associated subcutaneous tissue using a 27 G needle under ultrasound guidance. The metacarpophalangeal joint was brought into slight hyperextension. Subsequently, a 20 G 0.9x38mm needle, modified by bending approximately 40-45 degrees from the proximal 1/3 of the needle with the aid of a cap, was used. The needle was advanced in-plane from distal to proximal along the midline, with simultaneous movement towards the palmar surface, aiming to cut or loosen the pulley between the tendon and A1 pulley. The loosening procedure was repeated from the distal to proximal aspect of the pulley until the sensation of resistance at the needle tip disappeared. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- older 18 ages
Key inclusion criteria (4 listed)
- Being over 18 years of age
- Having had trigger finger complaints for more than 1 month
- Not having received any injections for trigger finger diagnosis within the last 1 month
- Signing the informed consent form indicating willingness to participate in the study
Key exclusion criteria (5 listed)
- Refusing to participate in the study
- Presence of partial or complete tendon rupture in the relevant tendon of the finger to be treated
- Presence of wounds and infection in the area where the procedure will be performed
- Pregnancy status
- History of allergy to the injected medications (local anesthetic, steroid)
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 |
|---|---|---|
| The percutaneous A1 pulley releaseUltrasound-guided percutaneous pulley release is a procedure aimed at loosening the pulley using various cutting instruments or hypodermic needles under ultrasound guidance. | Procedure or surgery | The percutaneous A1 pulley release group |
| The peritendinous Betamethasone groupUSG-guided injection of corticosteroid between the A1 pulley and the flexor tendon sheath. | Other | The peritendinous steroid group |
Primary outcome
Stage of the disease
Time frame: first week, first mount, third month
Modified Quinnel classification Stage 1: Normal movement, no pain. * Stage 2: Normal movement, occasional pain. * Stage 3: Irregular movement (catching without crepitus or locking). * Stage 4: Locking present, actively correctable. * Stage 5: Locking present, passively correctable.
2 secondary outcomes
Pain intensity
Time frame: first week, first month, third month
severity of triggering
Time frame: first week, first month, third month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2024.
- Individual participant dataSharing planned: No
Related trials for Trigger Finger
Recruiting
A Clinical Study to Compare Functional Outcomes After Surgery Using a Transverse or Longitudinal Surgical Incision in the Skin.
Functional Disturbance as Result
Recruiting
Low-Level Laser Therapy in the Treatment of Trigger Finger
Trigger Finger, Stenosing Tenosynovitis
Not yet recruiting
Understanding Patient Preferences When Deciding on a Voluntary Musculoskeletal Test
Non-traumatic Musculoskeletal Conditions, Carpal Tunnel Syndrome (CTS)
Enrolling by invitation
A Comparison of Metacarpophalangeal Joint Blocking Splint With Relative Motion Extension Splint for Trigger Finger
Trigger Finger
RecruitingPhase 4
Ketorolac in Upper Extremity Tendinopathy and Arthropathy
Osteoarthritis, Tendinopathy
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. This study is not recruiting at the moment.
zeliha gizem mac, MD principal investigator
university of health sciences, Department of PM&R
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Trigger Finger, run by Gaziler Physical Medicine and Rehabilitation Education 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 6 Jun 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stage of the disease (time frame: first week, first mount, third month). 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 6 Jun 2024.