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出境医 / 临床实验 / Extracorporeal Shock Wave in the Treatment of Trigger Finger

Extracorporeal Shock Wave in the Treatment of Trigger Finger

Study Description
Brief 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. 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.


Condition or disease Intervention/treatment Phase
Trigger Finger Device: Low energy ESWT Device: High energy ESWT Device: Sham ESWT Not Applicable

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
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant, Outcomes Assessor)
Masking Description: The patients will be randomized to each group. All participants are blinded to the treatment groups. All of the outcome will be followed by an assistant who is blinded to the allocation.
Primary Purpose: Treatment
Official Title: Extracorporeal Shock Wave Therapy Versus Placebo in the Treatment of Trigger Finger: a Randomized Controlled Study
Actual Study Start Date : February 20, 2019
Estimated Primary Completion Date : November 22, 2019
Estimated Study Completion Date : November 22, 2019
Arms and Interventions
Arm Intervention/treatment
Experimental: Low energy ESWT
Low energy ESWT (using LITEMED"LM-ESWT-mini System with 1500 impulses and 0.006mJ/mm2, 3bar, once per week for 4 weeks)
 Device: Low energy ESWT
1500 impulses and 0.006mJ/mm2, 3bar, once per week for 4 weeks
Other Name: "LITEMED"LM-ESWT-mini System
Experimental: High energy ESWT
High energy ESWT (using LITEMED"LM-ESWT-mini System with 1500 impulses and 0.01mJ/mm2, 5.8bar, once per week for 4 weeks)
 Device: High energy ESWT
1500 impulses and 0.01mJ/mm2, 5.8bar, once per week for 4 weeks
Other Name: "LITEMED"LM-ESWT-mini System
Sham Comparator: Sham treatment
All participants will receive sham treatment using ESWT Probe with only vibration without transferring energy once per week for 4 weeks.
 Device: Sham ESWT
sham treatment using ESWT Probe with only vibration without transferring energy once per week for 4 weeks
Other Name: "LITEMED"LM-ESWT-mini System
Outcome Measures
Primary Outcome Measures :
  1. 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.)


Secondary Outcome Measures :
  1. The change of Function Shoulder, and Hand questionnaire (qDASH) [ Time Frame: Baseline and Post-treatment 1, 3, 6 months ]
    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.

  2. The change of Pain [ Time Frame: Baseline and Post-treatment 1, 3, 6 months ]
    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.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Older than 20 years of age
  2. Grade 2~3 trigger finger based on the Quinnell classification

Exclusion Criteria:

  1. Previous treatment by physical therapy, local corticosteroid injection, or surgical release for trigger finger before the study
  2. The presence of a musculoskeletal disease or previous nerve injuries at the upper extremities
  3. Multiple trigger finger; local infection; malignancy; inflammatory arthritis; cardiac arrhythmia or cardiac pacemaker; and pregnancy.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Yu-Pin Chen, M.D. +886-933296411 99231@w.tmu.edu.tw

Locations
Layout table for location information
Taiwan
Taipei Medical University WanFang Hospital Recruiting
Taipei, Taiwan, 116
Contact: Yu-pin Chen, MD    +886933296411      
Sponsors and Collaborators
Taipei Medical University WanFang Hospital
Investigators
Layout table for investigator information
Principal Investigator: Yu-Pin Chen, M.D. Taipei Medical University WanFang Hospital
Tracking Information
First Submitted Date  ICMJE March 6, 2019
First Posted Date  ICMJE April 26, 2019
Last Update Posted Date April 26, 2019
Actual Study Start Date  ICMJE February 20, 2019
Estimated Primary Completion Date November 22, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 23, 2019) 		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.)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 23, 2019)
  • The change of Function Shoulder, and Hand questionnaire (qDASH) [ Time Frame: Baseline and Post-treatment 1, 3, 6 months ]
    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.
  • The change of Pain [ Time Frame: Baseline and Post-treatment 1, 3, 6 months ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Extracorporeal Shock Wave in the Treatment of Trigger Finger
Official Title  ICMJE Extracorporeal Shock Wave Therapy Versus Placebo in the Treatment of Trigger Finger: a Randomized Controlled Study
Brief 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. 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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant, Outcomes Assessor)
Masking Description:
The patients will be randomized to each group. All participants are blinded to the treatment groups. All of the outcome will be followed by an assistant who is blinded to the allocation.
Primary Purpose: Treatment
Condition  ICMJE Trigger Finger
Intervention  ICMJE
  • Device: Low energy ESWT
    1500 impulses and 0.006mJ/mm2, 3bar, once per week for 4 weeks
    Other Name: "LITEMED"LM-ESWT-mini System
  • Device: High energy ESWT
    1500 impulses and 0.01mJ/mm2, 5.8bar, once per week for 4 weeks
    Other Name: "LITEMED"LM-ESWT-mini System
  • Device: Sham ESWT
    sham treatment using ESWT Probe with only vibration without transferring energy once per week for 4 weeks
    Other Name: "LITEMED"LM-ESWT-mini System
Study Arms  ICMJE
  • Experimental: Low energy ESWT
    Low energy ESWT (using LITEMED"LM-ESWT-mini System with 1500 impulses and 0.006mJ/mm2, 3bar, once per week for 4 weeks)
    Intervention: Device: Low energy ESWT
  • Experimental: High energy ESWT
    High energy ESWT (using LITEMED"LM-ESWT-mini System with 1500 impulses and 0.01mJ/mm2, 5.8bar, once per week for 4 weeks)
    Intervention: Device: High energy ESWT
  • Sham Comparator: Sham treatment
    All participants will receive sham treatment using ESWT Probe with only vibration without transferring energy once per week for 4 weeks.
    Intervention: Device: Sham ESWT
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.
  • Strom L. Trigger finger in diabetes. J Med Soc N J. 1977 Nov;74(11):951-4.
  • Amirfeyz 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. Review.
  • Romeo 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. Review.
  • Yin 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.
  • Yang 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.
  • Arirachakaran 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. Review.
  • Alkhawashki 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. Review.
  • Cacchio 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. Erratum in: J Bone Joint Surg Am. 2010 May;92(5):1241.
  • Hsu 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.
  • Orhan 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.
  • Seok 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.
  • Yildirim 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.
  • Fleisch 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. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 23, 2019) 		60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 22, 2019
Estimated Primary Completion Date November 22, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Older than 20 years of age
  2. Grade 2~3 trigger finger based on the Quinnell classification

Exclusion Criteria:

  1. Previous treatment by physical therapy, local corticosteroid injection, or surgical release for trigger finger before the study
  2. The presence of a musculoskeletal disease or previous nerve injuries at the upper extremities
  3. Multiple trigger finger; local infection; malignancy; inflammatory arthritis; cardiac arrhythmia or cardiac pacemaker; and pregnancy.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03928873
Other Study ID Numbers  ICMJE N201810059
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: all collected IPD, all IPD that underlie results in a publication
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: starting 6 months after publication; ending 36 months after publication
Access Criteria:

With whom: For investigators whose proposed use of the data has been approved by an independent committee

For what type of analysis: For individual participants meta-analysis

For what mechanism: To gain access, data requestor should sign a data access agreement. Data are available for 3 years at third party website.
URL: http://drive.google.com/drive/folders/16-F5ZqSK0srtbkXdshBX0L9Ur8WyaGMX?usp=sharing
Responsible Party Taipei Medical University WanFang Hospital
Study Sponsor  ICMJE Taipei Medical University WanFang Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Yu-Pin Chen, M.D. Taipei Medical University WanFang Hospital
PRS Account Taipei Medical University WanFang Hospital
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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