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A prospective randomized controlled trial comparing night splinting with no splinting after treatment of mallet finger.

ABSTRACT: The effectiveness of night splinting after treatment of mallet finger is unknown. We tested the hypothesis that there is no difference in extensor lag between patients with mallet finger that wear a night splint for an additional month after 6 to 8 weeks of continuous splinting and patients that do not wear a night splint.Fifty-one patients were enrolled in this randomized controlled trial. At enrollment, range of motion was measured for the injured and contralateral uninjured finger. The follow-up was conducted approximately 4 weeks later in person (41 patients) or by phone (10 patients). Analysis was by intention to treat.There were no significant differences in final extensor lag between patients that did and did not receive a night splint. Among the 41 patients with a final in-person evaluation, the final average extensor lag was 14°, and 34 % (14 of 41 patients) had a lag of 20° or greater. Final extensor lag correlated significantly with age, enrollment distal interphalangeal joint (DIP) flexion and extensor lag, and final DIP flexion, with the latter two accounting for 28 % of the variation in final lag in the final multivariable model (p?

SUBMITTER: Gruber JS

PROVIDER: S-EPMC4022962 | biostudies-literature | 2014 Jun

REPOSITORIES: biostudies-literature

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A prospective randomized controlled trial comparing night splinting with no splinting after treatment of mallet finger.

Gruber Jillian S JS Bot Arjan G J AG Ring David D

Hand (New York, N.Y.) 20140601 2

<h4>Background</h4>The effectiveness of night splinting after treatment of mallet finger is unknown. We tested the hypothesis that there is no difference in extensor lag between patients with mallet finger that wear a night splint for an additional month after 6 to 8 weeks of continuous splinting and patients that do not wear a night splint.<h4>Methods</h4>Fifty-one patients were enrolled in this randomized controlled trial. At enrollment, range of motion was measured for the injured and contral ...[more]

PMID: 24839414

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Project description:BACKGROUND:Carpal tunnel syndrome (CTS) is a common cause of pain, weakness, sensory loss, and activity limitations. Currently, the most common initial treatment is use of a rigid splint immobilizing the wrist, usually during night-time, for several weeks. Evidence regarding the efficacy and effect durability of wrist splinting is weak. The treatment is associated with costs and may cause discomfort and limit daily and work activities. No placebo-controlled trials have been performed. METHODS:This is a randomized controlled trial designed to assess the efficacy of a rigid wrist splint compared with soft wrist bandage (placebo) in patients with primary idiopathic CTS. The trial will be conducted at an orthopedic department. Patients, 25 to 65 years old, who seek primary health-care with symptoms of CTS will be screened, and potentially eligible patients will be referred to the study center. Patients who fulfill the trial's eligibility criteria will be invited to participate. A total of 112 patients who provide informed consent will be randomly assigned to treatment with either a rigid wrist splint or a soft bandage to be used initially for 6 weeks at night and, if possible, during the day. The splints and bandages will be fitted with a temperature-monitoring device to measure the total time during which they have actually been worn. The trial participants will complete a questionnaire that includes the 6-item CTS symptoms scale (CTS-6); the 11-item disabilities of the arm, shoulder, and hand (QuickDASH) scale; and the EuroQol 5-dimension (EQ-5D) health status and quality-of-life measure at baseline and at 6, 12, 24, and 52 weeks after treatment start. The participants will undergo physical examination and nerve conduction testing at baseline and at 52 weeks. The trial's primary outcomes are the change in the CTS-6 score from baseline to 12 weeks and the rate of carpal tunnel release surgery at 52 weeks. DISCUSSION:This is the first placebo-controlled randomized trial with electronic monitoring of actual splint use and will provide evidence regarding the efficacy of wrist splinting in patients with CTS. TRIAL REGISTRATION:ISRCTN Registry, ISRCTN81836603 . Registered on May 5, 2018.

Project description:Although the standard treatment of acute appendicitis (AA) consists of an early appendectomy, there has recently been both an interest and an increase in the use of antibiotic therapy as the primary treatment for uncomplicated AA. However, the use of antibiotic therapy in the treatment of uncomplicated AA is still controversial.The APPAC trial is a randomized prospective controlled, open label, non-inferiority multicenter trial designed to compare antibiotic therapy (ertapenem) with emergency appendectomy in the treatment of uncomplicated AA. The primary endpoint of the study is the success of the randomized treatment. In the antibiotic treatment arm successful treatment is defined as being discharged from the hospital without the need for surgical intervention and no recurrent appendicitis during a minimum follow-up of one-year (treatment efficacy). Treatment efficacy in the operative treatment arm is defined as successful appendectomy evaluated to be 100%. Secondary endpoints are post-intervention complications, overall morbidity and mortality, the length of hospital stay and sick leave, treatment costs and pain scores (VAS, visual analoque scale). A maximum of 610 adult patients (aged 18-60 years) with a CT scan confirmed uncomplicated AA will be enrolled from six hospitals and randomized by a closed envelope method in a 1:1 ratio either to undergo emergency appendectomy or to receive ertapenem (1 g per day) for three days continued by oral levofloxacin (500 mg per day) plus metronidazole (1.5 g per day) for seven days. Follow-up by a telephone interview will be at 1 week, 2 months and 1, 3, 5 and 10 years; the primary and secondary endpoints of the trial will be evaluated at each time point.The APPAC trial aims to provide level I evidence to support the hypothesis that approximately 75-85% of patients with uncomplicated AA can be treated with effective antibiotic therapy avoiding unnecessary appendectomies and the related operative morbidity, also resulting in major cost savings.

Project description:BackgroundInternet-based cognitive behavioural therapy (iCBT) for depression is effective when guided by a clinician, less so if unguided.QuestionWould guidance from a technician be as effective as guidance from a clinician?MethodRandomized controlled non-inferiority trial comparing three groups: Clinician-assisted vs. technician-assisted vs. delayed treatment. Community-based volunteers applied to the VirtualClinic (www.virtualclinic.org.au) research program, and 141 participants with major depressive disorder were randomized. Participants in the clinician- and technician-assisted groups received access to an iCBT program for depression comprising 6 online lessons, weekly homework assignments, and weekly supportive contact over a treatment period of 8 weeks. Participants in the clinician-assisted group also received access to a moderated online discussion forum. The main outcome measures were the Beck Depression Inventory (BDI-II) and the Patient Health QUESTIONnaire-9 Item (PHQ-9). Completion rates were high, and at post-treatment, both treatment groups reduced scores on the BDI-II (p<0.001) and PHQ-9 (p<0.001) compared to the delayed treatment group but did not differ from each other. Within group effect sizes on the BDI-II were 1.27 and 1.20 for the clinician- and technician-assisted groups respectively, and on the PHQ-9, were 1.54 and 1.60 respectively. At 4-month follow-up participants in the technician group had made further improvements and had significantly lower scores on the PHQ-9 than those in the clinician group. A total of approximately 60 minutes of clinician or technician time was required per participant during the 8-week treatment program.ConclusionsBoth clinician- and technician-assisted treatment resulted in large effect sizes and clinically significant improvements comparable to those associated with face-to-face treatment, while a delayed treatment control group did not improve. These results provide support for large scale trials to determine the clinical effectiveness and acceptability of technician-assisted iCBT programs for depression. This form of treatment has potential to increase the capacity of existing mental health services.Trial registrationAustralian New Zealand Clinical Trials Registry ACTRN12609000559213.

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A prospective randomized controlled trial comparing night splinting with no splinting after treatment of mallet finger.

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A prospective randomized controlled trial comparing night splinting with no splinting after treatment of mallet finger.

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