Extracorporeal Shock Wave in the Treatment of Trigger Finger
Primary Purpose
Trigger Finger
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Low energy ESWT
High energy ESWT
Sham ESWT
Sponsored by
About this trial
This is an interventional treatment trial for Trigger Finger focused on measuring shock wave, trigger finger
Eligibility Criteria
Inclusion Criteria:
- Older than 20 years of age
- Grade 2~3 trigger finger based on the Quinnell classification
Exclusion Criteria:
- 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.
Sites / Locations
- Taipei Medical University WanFang HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Sham Comparator
Arm Label
Low energy ESWT
High energy ESWT
Sham treatment
Arm Description
Low 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 (using LITEMED"LM-ESWT-mini System with 1500 impulses and 0.01mJ/mm2, 5.8bar, once per week for 4 weeks)
All participants will receive sham treatment using ESWT Probe with only vibration without transferring energy once per week for 4 weeks.
Outcomes
Primary Outcome Measures
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.)
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT03928873
First Posted
March 6, 2019
Last Updated
April 23, 2019
Sponsor
Taipei Medical University WanFang Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03928873
Brief Title
Extracorporeal Shock Wave in the Treatment of Trigger Finger
Official Title
Extracorporeal Shock Wave Therapy Versus Placebo in the Treatment of Trigger Finger: a Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Unknown status
Study Start Date
February 20, 2019 (Actual)
Primary Completion Date
November 22, 2019 (Anticipated)
Study Completion Date
November 22, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taipei Medical University WanFang Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trigger Finger
Keywords
shock wave, trigger finger
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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:
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) 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
ParticipantOutcomes 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.
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Low energy ESWT
Arm Type
Experimental
Arm Description
Low energy ESWT (using LITEMED"LM-ESWT-mini System with 1500 impulses and 0.006mJ/mm2, 3bar, once per week for 4 weeks)
Arm Title
High energy ESWT
Arm Type
Experimental
Arm Description
High energy ESWT (using LITEMED"LM-ESWT-mini System with 1500 impulses and 0.01mJ/mm2, 5.8bar, once per week for 4 weeks)
Arm Title
Sham treatment
Arm Type
Sham Comparator
Arm Description
All participants will receive sham treatment using ESWT Probe with only vibration without transferring energy once per week for 4 weeks.
Intervention Type
Device
Intervention Name(s)
Low energy ESWT
Other Intervention Name(s)
"LITEMED"LM-ESWT-mini System
Intervention Description
1500 impulses and 0.006mJ/mm2, 3bar, once per week for 4 weeks
Intervention Type
Device
Intervention Name(s)
High energy ESWT
Other Intervention Name(s)
"LITEMED"LM-ESWT-mini System
Intervention Description
1500 impulses and 0.01mJ/mm2, 5.8bar, once per week for 4 weeks
Intervention Type
Device
Intervention Name(s)
Sham ESWT
Other Intervention Name(s)
"LITEMED"LM-ESWT-mini System
Intervention Description
sham treatment using ESWT Probe with only vibration without transferring energy once per week for 4 weeks
Primary Outcome Measure Information:
Title
The efficacy of ESWT in the treatment of trigger finger
Description
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.)
Time Frame
Baseline and Post-treatment 1, 3, 6 months
Secondary Outcome Measure Information:
Title
The change of Function Shoulder, and Hand questionnaire (qDASH)
Description
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.
Time Frame
Baseline and Post-treatment 1, 3, 6 months
Title
The change of Pain
Description
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.
Time Frame
Baseline and Post-treatment 1, 3, 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Older than 20 years of age
Grade 2~3 trigger finger based on the Quinnell classification
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yu-Pin Chen, M.D.
Phone
+886-933296411
Email
99231@w.tmu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yu-Pin Chen, M.D.
Organizational Affiliation
Taipei Medical University WanFang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taipei Medical University WanFang Hospital
City
Taipei
ZIP/Postal Code
116
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yu-pin Chen, MD
Phone
+886933296411
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
all collected IPD, all IPD that underlie results in a publication
IPD Sharing Time Frame
starting 6 months after publication; ending 36 months after publication
IPD Sharing 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.
IPD Sharing URL
http://drive.google.com/drive/folders/16-F5ZqSK0srtbkXdshBX0L9Ur8WyaGMX?usp=sharing
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Extracorporeal Shock Wave in the Treatment of Trigger Finger
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