Trigger FingerNCT03928873
Extracorporeal Shock Wave in the Treatment of Trigger Finger
A study testing Low energy ESWT and High energy ESWT in people with Trigger Finger, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
Trial summary
Trigger finger (TF) is a condition that causes triggering, snapping, or locking on flexion of the involved finger, with a life- time risk between 2%-3% in the general population. A variety of treatments have been described, but the most effective treatment for this common disorder is still under debate. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Trigger Finger
- What is being tested?
- Low energy ESWT and High energy ESWT
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 20 Feb 2019to 22 Nov 2019
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Older than 20 years of age
- Grade 2~3 trigger finger based on the Quinnell classification
Who cannot join
- Previous treatment by physical therapy, local corticosteroid injection, or surgical release for trigger finger before the study
- The presence of a musculoskeletal disease or previous nerve injuries at the upper extremities
- Multiple trigger finger; local infection; malignancy; inflammatory arthritis; cardiac arrhythmia or cardiac pacemaker; and pregnancy.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Medical University WanFang Hospital
Taipei, 116
Yu-pin Chen, MD, +886933296411
About this study
Official title: Extracorporeal Shock Wave Therapy Versus Placebo in the Treatment of Trigger Finger: a Randomized Controlled Study
Trigger finger (TF) is a condition that causes triggering, snapping, or locking on flexion of the involved finger, with a life- time risk between 2%-3% in the general population. A variety of treatments have been described, but the most effective treatment for this common disorder is still under debate. Recently, extracorporeal shock wave therapy(ESWT) has been advanced as a possible alternative to surgery for the treatment of musculoskeletal disorders in patients recalcitrant to traditional conservative treatment.
However, the effectiveness of ESWT on the treatment of TF is still in lack of evidence. The purpose of this study is to conduct a prospective randomized clinical trial to compare the efficacies of ESWT at two different energy flux density with placebo treatment for the management of TF. The investigators intended to enrolled 60 participants randomly allocated to three groups: low energy ESWT (1500 impulses and 0.006mJ/mm2, 3bar, once per week for 4 weeks), high energy ESWT (1500 impulses and 0.01mJ/mm2, 5.8bar, once per week for 4 weeks) or placebo treatment groups. The effectiveness of the treatment will be assessed using cure rates, a visual analogue scale, the frequency of triggering, the severity of triggering, the functional impact of triggering, and the Quick-Disabilities of the Arm, Shoulder, and Hand questionnaire (qDASH) at 1, 3, and 6 months after treatment. An intention-to-treat analysis will be used in this study. The investigators intend to determine the efficacy of ESWT in the treatment of TF and to find out the ideal energy set-up of ESWT for TF treatment.
Read the detailed description
Trigger finger (TF) (also known as stenosing tenovaginitis) is characteristic of triggering, snapping, or locking on flexion of the involved metacarpophalangeal joint of finger, with incidence of 2%-3% in the general population and approximately 10% in diabetic patients. A variety of treatments have been described, including activity restriction, stretching exercise, splitting, non-steroid anti-inflammatory drugs, steroid injection, percutaneous or open release. However, none of the above-mentioned treatments is absolutely better than the others. The most effective treatment for this common disorder is still under debate.
Recently, extracorporeal shock wave therapy (ESWT) is getting popular as an alternative to surgery for the treatment of musculoskeletal disorders in patients recalcitrant to traditional conservative treatment. ESWT has been reported to effectively treat orthopedic disorders, such as plantar fasciitis, lateral epicondylitis of the elbow, calcific tendinopathies of the shoulder, and the non-union of long bone fractures. Biologically, ESWT is believed to result in a mechanosensitive feedback between the acoustic impulse and the stimulated cells, involving specific transduction pathways and gene expression. Furthermore, previous studies have shown that increased angiogenetic growth factors with ESWT are causally related to enhanced neovascularization and blood supply in the tendinopathy area of the tendon. ESWT can also induce the repair of the inflamed tissues by tissue regeneration and stimulates nitric oxide synthase, leading to suppression of ongoing inflammation in the soft tissues. However, there are still few clinical evidence on ESWT in treatment of TF in the literature.
One randomized control study reported the efficacy of ESWT in treatment of TF in 2016, and claimed that ESWT was as effective as steroid injection in treatment of TF. However, this clinical study was limited to the lack of control group with placebo treatment, since steroid injection for TF is reported to be with short-term effect and only effective in 57% of patients. Further evidence on the efficacy of ESWT in treatment of TF is needed to be clarified. In addition, the ideal energy set-up and protocol for ESWT are still left to be proven.
Considering the noninvasive advantage and potentially biological effect on the thickening of the flexor tendon and its sheath, the investigators hypothesize ESWT is effective on relieving the symptoms of TF. The purpose of this study is to conduct a prospective randomized clinical trial to compare the efficacies of ESWT at two different energy flux density with placebo treatment for the management of TF. The investigators intended to determine the efficacy of ESWT in the treatment of TF and to find out the ideal energy set-up of ESWT for TF treatment.
- Conditions
- Trigger Finger
- Being tested
- Low energy ESWT, High energy ESWT, Sham ESWT
- Keywords
- shock wave, trigger finger
- 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.
Low energy ESWTDevice
Also called "LITEMED"LM-ESWT-mini System
1500 impulses and 0.006mJ/mm2, 3bar, once per week for 4 weeks
High energy ESWTDevice
Also called "LITEMED"LM-ESWT-mini System
1500 impulses and 0.01mJ/mm2, 5.8bar, once per week for 4 weeks
Sham ESWTDevice
Also called "LITEMED"LM-ESWT-mini System
sham treatment using ESWT Probe with only vibration without transferring energy once per week for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Low energy ESWT | Experimental | Low energy ESWT (using LITEMED"LM-ESWT-mini System with 1500 impulses and 0.006mJ/mm2, 3bar, once per week for 4 weeks) Receives: Device: Low energy ESWT |
| High energy ESWT | Experimental | High energy ESWT (using LITEMED"LM-ESWT-mini System with 1500 impulses and 0.01mJ/mm2, 5.8bar, once per week for 4 weeks) Receives: Device: High energy ESWT |
| Sham treatment | Sham comparator | All participants will receive sham treatment using ESWT Probe with only vibration without transferring energy once per week for 4 weeks. Receives: Device: Sham ESWT |
What is being measured
The primary outcome is the main question the study is designed to answer.
The efficacy of ESWT in the treatment of trigger finger
Change from baseline the frequency of triggering, the severity of triggering and the functional impact of triggering at 1, 3, 6 months. We used a trigger finger assessment scale which included three 0- to 10- point subscales to determine the frequency, severity and functional impact of triggering to define the efficacy of treatment. In each subscale, the higher score means worse outcome. (Scale reference: Tarbhai K, Hannah S, von Schroeder HP: Trigger finger treatment: a comparison of 2 splint designs. J Hand Surg Am 2012, 37(2):243-249, 249.e241.)
Measured: Baseline and Post-treatment 1, 3, 6 months
Secondary outcomes (2)
The change of Function Shoulder, and Hand questionnaire (qDASH)
Functional evaluation utilizing the Quick-Disabilities of the Arm (q-DASH). The QuickDASH uses 11 items (scored 1-5) to measure physical function and symptoms in people with any or multiple musculoskeletal disorders of the upper limb. A higher score means worse disability.
Measured: Baseline and Post-treatment 1, 3, 6 months
The change of Pain
evaluation utilizing Visual analogue scale (VAS). The visual analog scale (VAS) is an instrument regularly used to measure pain intensity based on a 0-10 cm. In the present trial, the researcher asked the patients: "Based on VAS, how much pain are you in/ experiencing?". The higher score means the more severe pain.
Measured: Baseline and Post-treatment 1, 3, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2019
- Study start20 Feb 2019
- Primary completion22 Nov 2019 (estimated)
- Study completion22 Nov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- 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 pilot experiment on safety and effectiveness of Extracorporeal shock wave therapy (ESWT), we choose the two energy doses of ESWT for experiment: 1. Low energy ESWT (1500 impulses and 0.006mJ/mm2, 3bar, once per week for 4 weeks) 2. High energy ESWT (1500 impulses and 0.01mJ/mm2, 5.8bar, once per week for 4 weeks) In order to realize the effectiveness of ESWT on trigger finger, we will enroll a placebo group in which all participants will receive ESWT probe treatment with only vibration without transferring energy once per week for 4 weeks.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University WanFang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yu-Pin Chen, M.D., Principal investigator, Taipei Medical University WanFang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03928873
- Sponsor's protocol ID
- N201810059
- Status last verified
- Nov 2018
- First submitted
- 6 Mar 2019
- Last updated
- 26 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all collected IPD, all IPD that underlie results in a publication
Publications
Koh S, Nakamura S, Hattori T, Hirata H. Trigger digits in diabetes: their incidence and characteristics. J Hand Surg Eur Vol. 2010 May;35(4):302-5. doi: 10.1177/1753193409341103. Epub 2009 Aug 17.
PubMed 19687073Strom L. Trigger finger in diabetes. J Med Soc N J. 1977 Nov;74(11):951-4. No abstract available.
PubMed 269967Amirfeyz R, McNinch R, Watts A, Rodrigues J, Davis TRC, Glassey N, Bullock J. Evidence-based management of adult trigger digits. J Hand Surg Eur Vol. 2017 Jun;42(5):473-480. doi: 10.1177/1753193416682917. Epub 2016 Dec 21.
PubMed 28488453Romeo P, Lavanga V, Pagani D, Sansone V. Extracorporeal shock wave therapy in musculoskeletal disorders: a review. Med Princ Pract. 2014;23(1):7-13. doi: 10.1159/000355472. Epub 2013 Nov 5.
PubMed 24217134Yin M, Chen N, Huang Q, Marla AS, Ma J, Ye J, Mo W. New and Accurate Predictive Model for the Efficacy of Extracorporeal Shock Wave Therapy in Managing Patients With Chronic Plantar Fasciitis. Arch Phys Med Rehabil. 2017 Dec;98(12):2371-2377. doi: 10.1016/j.apmr.2017.05.016. Epub 2017 Jun 17.
PubMed 28634056Yang TH, Huang YC, Lau YC, Wang LY. Efficacy of Radial Extracorporeal Shock Wave Therapy on Lateral Epicondylosis, and Changes in the Common Extensor Tendon Stiffness with Pretherapy and Posttherapy in Real-Time Sonoelastography: A Randomized Controlled Study. Am J Phys Med Rehabil. 2017 Feb;96(2):93-100. doi: 10.1097/PHM.0000000000000547.
PubMed 27323324Arirachakaran A, Boonard M, Yamaphai S, Prommahachai A, Kesprayura S, Kongtharvonskul J. Extracorporeal shock wave therapy, ultrasound-guided percutaneous lavage, corticosteroid injection and combined treatment for the treatment of rotator cuff calcific tendinopathy: a network meta-analysis of RCTs. Eur J Orthop Surg Traumatol. 2017 Apr;27(3):381-390. doi: 10.1007/s00590-016-1839-y. Epub 2016 Aug 23.
PubMed 27554465Alkhawashki HM. Shock wave therapy of fracture nonunion. Injury. 2015 Nov;46(11):2248-52. doi: 10.1016/j.injury.2015.06.035. Epub 2015 Jul 3.
PubMed 26323379Cacchio A, Giordano L, Colafarina O, Rompe JD, Tavernese E, Ioppolo F, Flamini S, Spacca G, Santilli V. Extracorporeal shock-wave therapy compared with surgery for hypertrophic long-bone nonunions. J Bone Joint Surg Am. 2009 Nov;91(11):2589-97. doi: 10.2106/JBJS.H.00841.
PubMed 19884432Hsu RW, Hsu WH, Tai CL, Lee KF. Effect of shock-wave therapy on patellar tendinopathy in a rabbit model. J Orthop Res. 2004 Jan;22(1):221-7. doi: 10.1016/S0736-0266(03)00138-4.
PubMed 14656684Orhan Z, Ozturan K, Guven A, Cam K. The effect of extracorporeal shock waves on a rat model of injury to tendo Achillis. A histological and biomechanical study. J Bone Joint Surg Br. 2004 May;86(4):613-8.
PubMed 15174564Seok H, Kim SH. The effectiveness of extracorporeal shock wave therapy vs. local steroid injection for management of carpal tunnel syndrome: a randomized controlled trial. Am J Phys Med Rehabil. 2013 Apr;92(4):327-34. doi: 10.1097/PHM.0b013e31826edc7b.
PubMed 23044704Yildirim P, Gultekin A, Yildirim A, Karahan AY, Tok F. Extracorporeal shock wave therapy versus corticosteroid injection in the treatment of trigger finger: a randomized controlled study. J Hand Surg Eur Vol. 2016 Nov;41(9):977-983. doi: 10.1177/1753193415622733. Epub 2016 Sep 28.
PubMed 26763271Fleisch SB, Spindler KP, Lee DH. Corticosteroid injections in the treatment of trigger finger: a level I and II systematic review. J Am Acad Orthop Surg. 2007 Mar;15(3):166-71. doi: 10.5435/00124635-200703000-00006.
PubMed 17341673Chen YP, Lin CY, Kuo YJ, Lee OK. Extracorporeal Shockwave Therapy in the Treatment of Trigger Finger: A Randomized Controlled Study. Arch Phys Med Rehabil. 2021 Nov;102(11):2083-2090.e1. doi: 10.1016/j.apmr.2021.04.015. Epub 2021 May 21.
PubMed 34029555
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extracorporeal Shock Wave Therapy Versus Placebo in the Treatment of Trigger Finger: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT03928873
- Acronym / sponsor ID
- N201810059
- Conditions
- Trigger Finger
- Keywords
- shock wave, trigger finger
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Taipei Medical University WanFang HospitalUniversity, hospital or other
- Study start
- 20 Feb 2019 (actual)
- Primary completion
- 22 Nov 2019 (estimated)
- Study completion
- 22 Nov 2019 (estimated)
- First posted
- 26 Apr 2019 (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 (TF) is a condition that causes triggering, snapping, or locking on flexion of the involved finger, with a life- time risk between 2%-3% in the general population. A variety of treatments have been described, but the most effective treatment for this common disorder is still under debate. Recently, extracorporeal shock wave therapy(ESWT) has been advanced as a possible alternative to surgery for the treatment of musculoskeletal disorders in patients recalcitrant to traditional conservative treatment.
However, the effectiveness of ESWT on the treatment of TF is still in lack of evidence. The purpose of this study is to conduct a prospective randomized clinical trial to compare the efficacies of ESWT at two different energy flux density with placebo treatment for the management of TF. The investigators intended to enrolled 60 participants randomly allocated to three groups: low energy ESWT (1500 impulses and 0.006mJ/mm2, 3bar, once per week for 4 weeks), high energy ESWT (1500 impulses and 0.01mJ/mm2, 5.8bar, once per week for 4 weeks) or placebo treatment groups. The effectiveness of the treatment will be assessed using cure rates, a visual analogue scale, the frequency of triggering, the severity of triggering, the functional impact of triggering, and the Quick-Disabilities of the Arm, Shoulder, and Hand questionnaire (qDASH) at 1, 3, and 6 months after treatment. An intention-to-treat analysis will be used in this study. The investigators intend to determine the efficacy of ESWT in the treatment of TF and to find out the ideal energy set-up of ESWT for TF treatment.
Detailed description
Trigger finger (TF) (also known as stenosing tenovaginitis) is characteristic of triggering, snapping, or locking on flexion of the involved metacarpophalangeal joint of finger, with incidence of 2%-3% in the general population and approximately 10% in diabetic patients. A variety of treatments have been described, including activity restriction, stretching exercise, splitting, non-steroid anti-inflammatory drugs, steroid injection, percutaneous or open release. However, none of the above-mentioned treatments is absolutely better than the others. The most effective treatment for this common disorder is still under debate.
Recently, extracorporeal shock wave therapy (ESWT) is getting popular as an alternative to surgery for the treatment of musculoskeletal disorders in patients recalcitrant to traditional conservative treatment. ESWT has been reported to effectively treat orthopedic disorders, such as plantar fasciitis, lateral epicondylitis of the elbow, calcific tendinopathies of the shoulder, and the non-union of long bone fractures. Biologically, ESWT is believed to result in a mechanosensitive feedback between the acoustic impulse and the stimulated cells, involving specific transduction pathways and gene expression. Furthermore, previous studies have shown that increased angiogenetic growth factors with ESWT are causally related to enhanced neovascularization and blood supply in the tendinopathy area of the tendon. ESWT can also induce the repair of the inflamed tissues by tissue regeneration and stimulates nitric oxide synthase, leading to suppression of ongoing inflammation in the soft tissues. However, there are still few clinical evidence on ESWT in treatment of TF in the literature.
One randomized control study reported the efficacy of ESWT in treatment of TF in 2016, and claimed that ESWT was as effective as steroid injection in treatment of TF. However, this clinical study was limited to the lack of control group with placebo treatment, since steroid injection for TF is reported to be with short-term effect and only effective in 57% of patients. Further evidence on the efficacy of ESWT in treatment of TF is needed to be clarified. In addition, the ideal energy set-up and protocol for ESWT are still left to be proven.
Considering the noninvasive advantage and potentially biological effect on the thickening of the flexor tendon and its sheath, the investigators hypothesize ESWT is effective on relieving the symptoms of TF. The purpose of this study is to conduct a prospective randomized clinical trial to compare the efficacies of ESWT at two different energy flux density with placebo treatment for the management of TF. The investigators intended to determine the efficacy of ESWT in the treatment of TF and to find out the ideal energy set-up of ESWT for TF treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Our pilot experiment on safety and effectiveness of Extracorporeal shock wave therapy (ESWT), we choose the two energy doses of ESWT for experiment: 1. Low energy ESWT (1500 impulses and 0.006mJ/mm2, 3bar, once per week for 4 weeks) 2. High energy ESWT (1500 impulses and 0.01mJ/mm2, 5.8bar, once per week for 4 weeks) In order to realize the effectiveness of ESWT on trigger finger, we will enroll a placebo group in which all participants will receive ESWT probe treatment with only vibration without transferring energy once per week for 4 weeks.
| Arm | Type | Receives |
|---|---|---|
| Low energy ESWT | Experimental | Device: Low energy ESWTLow energy ESWT (using LITEMED"LM-ESWT-mini System with 1500 impulses and 0.006mJ/mm2, 3bar, once per week for 4 weeks) |
| High energy ESWT | Experimental | Device: High energy ESWTHigh energy ESWT (using LITEMED"LM-ESWT-mini System with 1500 impulses and 0.01mJ/mm2, 5.8bar, once per week for 4 weeks) |
| Sham treatment | Sham comparator | Device: Sham ESWTAll participants will receive sham treatment using ESWT Probe with only vibration without transferring energy once per week for 4 weeks. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Older than 20 years of age
- Grade 2~3 trigger finger based on the Quinnell classification
Key exclusion criteria (3 listed)
- Previous treatment by physical therapy, local corticosteroid injection, or surgical release for trigger finger before the study
- The presence of a musculoskeletal disease or previous nerve injuries at the upper extremities
- Multiple trigger finger; local infection; malignancy; inflammatory arthritis; cardiac arrhythmia or cardiac pacemaker; and pregnancy.
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 |
|---|---|---|
| Low energy ESWTAlso: "LITEMED"LM-ESWT-mini System1500 impulses and 0.006mJ/mm2, 3bar, once per week for 4 weeks | Device | Low energy ESWT |
| High energy ESWTAlso: "LITEMED"LM-ESWT-mini System1500 impulses and 0.01mJ/mm2, 5.8bar, once per week for 4 weeks | Device | High energy ESWT |
| Sham ESWTAlso: "LITEMED"LM-ESWT-mini Systemsham treatment using ESWT Probe with only vibration without transferring energy once per week for 4 weeks | Device | Sham treatment |
Primary outcome
The efficacy of ESWT in the treatment of trigger finger
Time frame: Baseline and Post-treatment 1, 3, 6 months
Change from baseline the frequency of triggering, the severity of triggering and the functional impact of triggering at 1, 3, 6 months. We used a trigger finger assessment scale which included three 0- to 10- point subscales to determine the frequency, severity and functional impact of triggering to define the efficacy of treatment. In each subscale, the higher score means worse outcome. (Scale reference: Tarbhai K, Hannah S, von Schroeder HP: Trigger finger treatment: a comparison of 2 splint designs. J Hand Surg Am 2012, 37(2):243-249, 249.e241.)
2 secondary outcomes
The change of Function Shoulder, and Hand questionnaire (qDASH)
Time frame: Baseline and Post-treatment 1, 3, 6 months
The change of Pain
Time frame: Baseline and Post-treatment 1, 3, 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2019.
- Background: PubMed 19687073Koh S, Nakamura S, Hattori T, Hirata H. Trigger digits in diabetes: their incidence and characteristics. J Hand Surg Eur Vol. 2010 May;35(4):302-5. doi: 10.1177/1753193409341103. Epub 2009 Aug 17.
- Background: PubMed 269967Strom L. Trigger finger in diabetes. J Med Soc N J. 1977 Nov;74(11):951-4. No abstract available.
- Background: PubMed 28488453Amirfeyz R, McNinch R, Watts A, Rodrigues J, Davis TRC, Glassey N, Bullock J. Evidence-based management of adult trigger digits. J Hand Surg Eur Vol. 2017 Jun;42(5):473-480. doi: 10.1177/1753193416682917. Epub 2016 Dec 21.
- Background: PubMed 24217134Romeo P, Lavanga V, Pagani D, Sansone V. Extracorporeal shock wave therapy in musculoskeletal disorders: a review. Med Princ Pract. 2014;23(1):7-13. doi: 10.1159/000355472. Epub 2013 Nov 5.
- Background: PubMed 28634056Yin M, Chen N, Huang Q, Marla AS, Ma J, Ye J, Mo W. New and Accurate Predictive Model for the Efficacy of Extracorporeal Shock Wave Therapy in Managing Patients With Chronic Plantar Fasciitis. Arch Phys Med Rehabil. 2017 Dec;98(12):2371-2377. doi: 10.1016/j.apmr.2017.05.016. Epub 2017 Jun 17.
- Background: PubMed 27323324Yang TH, Huang YC, Lau YC, Wang LY. Efficacy of Radial Extracorporeal Shock Wave Therapy on Lateral Epicondylosis, and Changes in the Common Extensor Tendon Stiffness with Pretherapy and Posttherapy in Real-Time Sonoelastography: A Randomized Controlled Study. Am J Phys Med Rehabil. 2017 Feb;96(2):93-100. doi: 10.1097/PHM.0000000000000547.
- Background: PubMed 27554465Arirachakaran A, Boonard M, Yamaphai S, Prommahachai A, Kesprayura S, Kongtharvonskul J. Extracorporeal shock wave therapy, ultrasound-guided percutaneous lavage, corticosteroid injection and combined treatment for the treatment of rotator cuff calcific tendinopathy: a network meta-analysis of RCTs. Eur J Orthop Surg Traumatol. 2017 Apr;27(3):381-390. doi: 10.1007/s00590-016-1839-y. Epub 2016 Aug 23.
- Background: PubMed 26323379Alkhawashki HM. Shock wave therapy of fracture nonunion. Injury. 2015 Nov;46(11):2248-52. doi: 10.1016/j.injury.2015.06.035. Epub 2015 Jul 3.
- Background: PubMed 19884432Cacchio A, Giordano L, Colafarina O, Rompe JD, Tavernese E, Ioppolo F, Flamini S, Spacca G, Santilli V. Extracorporeal shock-wave therapy compared with surgery for hypertrophic long-bone nonunions. J Bone Joint Surg Am. 2009 Nov;91(11):2589-97. doi: 10.2106/JBJS.H.00841.
- Background: PubMed 14656684Hsu RW, Hsu WH, Tai CL, Lee KF. Effect of shock-wave therapy on patellar tendinopathy in a rabbit model. J Orthop Res. 2004 Jan;22(1):221-7. doi: 10.1016/S0736-0266(03)00138-4.
- Background: PubMed 15174564Orhan Z, Ozturan K, Guven A, Cam K. The effect of extracorporeal shock waves on a rat model of injury to tendo Achillis. A histological and biomechanical study. J Bone Joint Surg Br. 2004 May;86(4):613-8.
- Background: PubMed 23044704Seok H, Kim SH. The effectiveness of extracorporeal shock wave therapy vs. local steroid injection for management of carpal tunnel syndrome: a randomized controlled trial. Am J Phys Med Rehabil. 2013 Apr;92(4):327-34. doi: 10.1097/PHM.0b013e31826edc7b.
- Individual participant dataSharing planned: Yes. all collected IPD, all IPD that underlie results in a publication
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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.
Yu-Pin Chen, M.D. principal investigator
Taipei Medical University WanFang 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 Low energy ESWT and High energy ESWT in people with Trigger Finger, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
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 3 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: status not confirmed, as of the sponsor's last update on 26 Apr 2019. 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 Taiwan. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yu-Pin Chen, M.D. (+886-933296411, 99231@w.tmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The efficacy of ESWT in the treatment of trigger finger (time frame: Baseline and Post-treatment 1, 3, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03928873, which also lists 15 linked publications.
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 26 Apr 2019.