Trigger FingerNCT04855942
Focused Extracorporeal Shock Wave Therapy (ESWT) Versus Traditional Physiotherapy in the Treatment of Trigger Finger
A study testing Focused Extracorporeal Shock Wave Therapy (ESWT) and physiotherapy in people with Trigger Finger and Stenosing Tenosynovitis, run by Cheng-Hsin General Hospital.
Trial summary
Trigger finger is the common name of stenosing tenosynovitis of fingers, caused by repetitive trauma. Conservative treatment includes NSAIDs or other analgesic agents, activity modification, splint, and physiotherapy. Operation could be considered if conservative treatments fails. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Trigger Finger, Stenosing Tenosynovitis
- What is being tested?
- Focused Extracorporeal Shock Wave Therapy (ESWT) and physiotherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2021to 31 Aug 2022
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Quinnel classification grade 2 or 3
- who has only one trigger
Who cannot join
- who had ever treated the trigger finger
- who has other musculoskeletal disease of the upper limb
- who has severe coagulopathy disease
- who is pregnant
- who has arrhythmia or has a pacemaker
- there is sensory impairment, scar, edema at the trigger finger
- who has cognitive dysfunction
About this study
Official title: Focused Extracorporeal Shock Wave Therapy (ESWT) Versus Traditional Physiotherapy in the Treatment of Trigger Finger: a Randomized Controlled Study
Trigger finger is the common name of stenosing tenosynovitis of fingers, caused by repetitive trauma. Conservative treatment includes NSAIDs or other analgesic agents, activity modification, splint, and physiotherapy. Operation could be considered if conservative treatments fails. With literature reviewed, there is no treatment which is both non-invasive and effective, and also could avoid recurrence well.
Extracorporeal shock wave therapy could induce angiogenesis, anti-inflammatory reaction, and recruitment of fibroblast. Although extracorporeal shock wave has been utilized in musculoskeletal diseases for more than twenty years, there is no well-designed clinical trial to prove the effectiveness of extracorporeal shock wave in treating trigger finger. The purpose of this study is to compare the effectiveness of extracorporeal shock wave therapy with traditional physical therapy for the management of trigger finger.
- Conditions
- Trigger Finger, Stenosing Tenosynovitis
- Being tested
- Focused Extracorporeal Shock Wave Therapy (ESWT), physiotherapy
- Keywords
- extracorporeal shock wave, trigger finger, stenosing tenosynovitis
- Medical subject headings
- Trigger Finger Disorder, Tendon Entrapment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focused Extracorporeal Shock Wave Therapy (ESWT)Device
2000 impulses of 5 Hz and 0.32 mJ/mm2 , twice per week for 3 weeks
physiotherapyDevice
therapeutic ultrasound, 12 times in 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Focused Extracorporeal Shock Wave Therapy (ESWT) | Experimental | 2000 impulses of 5 Hz and 0.32 mJ/mm2 , twice per week for 3 weeks Receives: Device: Focused Extracorporeal Shock Wave Therapy (ESWT) |
| Physiotherapy | Active comparator | therapeutic ultrasound, 12 times in 3 weeks Receives: Device: physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quinnell stages of triggering
Quinnell stages of triggering classifies the trigger finger using five types during flexion and extension: normal movement (Type 0), uneven movement (Type I), actively correctable (Type II), passively correctable (Type III) and fixed deformity (Type IV).
Measured: 15 weeks
11-point numeric scale of pain
The 11-point numeric scale of pain requires the patient to rate their pain on a defined scale. 0 is no pain and 10 is the worst pain imaginable.
Measured: 15 weeks
Chinese quick DASH (disabilities of the Arm, Shoulder, and Hand questionnaire)
This questionnaire is a self-administered region-specific outcome instrument developed as a measure of self-rated upper-extremity disability and symptoms. The investigators chose the first two components: the disability and symptom section (11 items, scored 1-5). The lower score means better condition of upper limbs, and vice versa.
Measured: 15 weeks
strength of hand grip
The strength of hand grip is to measure the maximum isometric strength of the hand and forearm muscles by a electicial grip strength device.
Measured: 15 weeks
sonographic image
The investigators would record the characteristics of acquired sonographic images, such like the thickness of finger flexor tendon and A1 pulley, the presence of tendon sheath effusion, and the presence of increased vascularity by Doppler images.
Measured: 15 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2021
- Study start1 May 2021 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Aug 2022 (estimated)
Why it stopped: Due to the outbreak COVID-19 in our country, the patients coming to our hospital drastically decreased. We could hardly enroll participants due to the paucity of our patients for more than six months, so we decided to withdrawn this study.
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
- Model description
- Our study design is mainly to compare the therapeutic effect to trigger finger between extracorporeal shock wave (PiezoWave2 ECO, produced by Richard Wolf) and traditional physiotherapy.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cheng-Hsin General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04855942
- Sponsor's protocol ID
- (811)109A-50
- Status last verified
- Jul 2022
- First submitted
- 10 Mar 2021
- Last updated
- 25 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Focused Extracorporeal Shock Wave Therapy (ESWT) Versus Traditional Physiotherapy in the Treatment of Trigger Finger: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04855942
- Acronym / sponsor ID
- (811)109A-50
- Conditions
- Trigger Finger, Stenosing Tenosynovitis
- Keywords
- extracorporeal shock wave, trigger finger, stenosing tenosynovitis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to the outbreak COVID-19 in our country, the patients coming to our hospital drastically decreased. We could hardly enroll participants due to the paucity of our patients for more than six months, so we decided to withdrawn this study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Cheng-Hsin General HospitalUniversity, hospital or other
- Study start
- 1 May 2021 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Aug 2022 (estimated)
- First posted
- 22 Apr 2021 (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.
Trigger finger is the common name of stenosing tenosynovitis of fingers, caused by repetitive trauma. Conservative treatment includes NSAIDs or other analgesic agents, activity modification, splint, and physiotherapy. Operation could be considered if conservative treatments fails. With literature reviewed, there is no treatment which is both non-invasive and effective, and also could avoid recurrence well.
Extracorporeal shock wave therapy could induce angiogenesis, anti-inflammatory reaction, and recruitment of fibroblast. Although extracorporeal shock wave has been utilized in musculoskeletal diseases for more than twenty years, there is no well-designed clinical trial to prove the effectiveness of extracorporeal shock wave in treating trigger finger. The purpose of this study is to compare the effectiveness of extracorporeal shock wave therapy with traditional physical therapy for the management of trigger finger.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Our study design is mainly to compare the therapeutic effect to trigger finger between extracorporeal shock wave (PiezoWave2 ECO, produced by Richard Wolf) and traditional physiotherapy.
| Arm | Type | Receives |
|---|---|---|
| Focused Extracorporeal Shock Wave Therapy (ESWT) | Experimental | Device: Focused Extracorporeal Shock Wave Therapy (ESWT)2000 impulses of 5 Hz and 0.32 mJ/mm2 , twice per week for 3 weeks |
| Physiotherapy | Active comparator | Device: physiotherapytherapeutic ultrasound, 12 times in 3 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Quinnel classification grade 2 or 3
- who has only one trigger
Key exclusion criteria (7 listed)
- who had ever treated the trigger finger
- who has other musculoskeletal disease of the upper limb
- who has severe coagulopathy disease
- who is pregnant
- who has arrhythmia or has a pacemaker
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 |
|---|---|---|
| Focused Extracorporeal Shock Wave Therapy (ESWT)2000 impulses of 5 Hz and 0.32 mJ/mm2 , twice per week for 3 weeks | Device | Focused Extracorporeal Shock Wave Therapy (ESWT) |
| physiotherapytherapeutic ultrasound, 12 times in 3 weeks | Device | Physiotherapy |
Primary outcome
Quinnell stages of triggering
Time frame: 15 weeks
Quinnell stages of triggering classifies the trigger finger using five types during flexion and extension: normal movement (Type 0), uneven movement (Type I), actively correctable (Type II), passively correctable (Type III) and fixed deformity (Type IV).
11-point numeric scale of pain
Time frame: 15 weeks
The 11-point numeric scale of pain requires the patient to rate their pain on a defined scale. 0 is no pain and 10 is the worst pain imaginable.
Chinese quick DASH (disabilities of the Arm, Shoulder, and Hand questionnaire)
Time frame: 15 weeks
This questionnaire is a self-administered region-specific outcome instrument developed as a measure of self-rated upper-extremity disability and symptoms. The investigators chose the first two components: the disability and symptom section (11 items, scored 1-5). The lower score means better condition of upper limbs, and vice versa.
strength of hand grip
Time frame: 15 weeks
The strength of hand grip is to measure the maximum isometric strength of the hand and forearm muscles by a electicial grip strength device.
sonographic image
Time frame: 15 weeks
The investigators would record the characteristics of acquired sonographic images, such like the thickness of finger flexor tendon and A1 pulley, the presence of tendon sheath effusion, and the presence of increased vascularity by Doppler images.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2022.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Focused Extracorporeal Shock Wave Therapy (ESWT) and physiotherapy in people with Trigger Finger and Stenosing Tenosynovitis, run by Cheng-Hsin General Hospital.
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 7 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: withdrawn, as of the sponsor's last update on 25 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Quinnell stages of triggering (time frame: 15 weeks). The study lists 5 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 25 Jul 2022.