Trigger Finger Clinical Trial
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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | November 22, 2019 |
Est. primary completion date | November 22, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Taiwan | Taipei Medical University WanFang Hospital | Taipei |
Lead Sponsor | Collaborator |
---|---|
Taipei Medical University WanFang Hospital |
Taiwan,
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* Note: There are 14 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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.) | Baseline and Post-treatment 1, 3, 6 months | |
Secondary | 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. | Baseline and Post-treatment 1, 3, 6 months | |
Secondary | 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. | Baseline and Post-treatment 1, 3, 6 months |
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