Ultra-Minimally Invasive Sonographically Guided Trigger Digit Release: An External Pilot Study

Objective: The most common surgical option for releasing the first annular pulley in trigger digit is classic open surgery followed by blind percutaneous release. However, they have been related to major complications and incomplete releases, respectively. Classic. The intrasheath sonographically guided first annular pulley release has recently shown to be safe and effective in every digit. The objectives of this pilot study were to preliminary compare clinically an intrasheath sonographically-guided first annular pulley release versus a classic open technique and to evaluate the feasibility of a future clinical trial in patients with trigger digits. Methods: Thirty patients were 1:1 randomized in an external pilot study comparing the two surgical techniques: a percutaneous sonographically-guided release performed through a 1 mm incision using a hook knife versus a classic open surgery with a 1 cm incision. Inclusion criteria were primary trigger digit grade III (Froimson). We defined success if primary (safety and efficacy) and secondary objectives (recruitment rates, compliance, completion, treatment blinding, personnel resources and sample size calculation for the clinical trial) could be matched. We registered the grip strength, the Quick-DASH score and a set of clinical postoperative variables at 1, 3 and 6 weeks and at 3 months. We calculated the sample size for the clinical trial using the Quick-DASH at the end of the follow-up. Outcomes assessors were blinded. Results: All patients in both groups showed resolution of their symptoms with no associated complications or relapses. Secondary feasibility objectives were matched: 76.9% of eligible patients were included in the study, 3.3% refused randomization, 20 patients per month were recruited, 100% received blinded treatment, 98.5% showed compliance and 100% completed the study. The sample size for a future clinical trial was of 84 patients. There were no differences in grip strength. The intrasheath sonographically-guided first annular pulley release showed significantly better scores for the Quick-DASH, until the 6th postoperative week. Conclusions: The intrasheath sonographically-guided first annular pulley release is safe and efficacious and it shows a trend towards clinical superiority versus the classic open procedure, which should be confirmed with a clinical trial. Our study shows that a randomized clinical trial is feasible.

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2070. Antibiotic Therapy Effects on Enterobacteriaceae Detection Directly from Blood: Pilot Study Implications for Future Clinical Trial Design

Open Forum Infectious Diseases ◽

10.1093/ofid/ofy210.1726 ◽

2018 ◽

Vol 5 (suppl_1) ◽

pp. S604-S604

Author(s):

Amy Irwin ◽

Sara Giddins ◽

Irina Yushkevich ◽

Alexiss Jeffers ◽

Michelle Barron ◽

...

Keyword(s):

Clinical Trial ◽

Pilot Study ◽

Antibiotic Therapy ◽

Trial Design ◽

Clinical Trial Design ◽

Future Clinical Trial

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Prolotherapy vs Radial Extracorporeal Shock Wave Therapy in the Short-term Treatment of Lateral Epicondylosis: A Randomized Clinical Trial

Pain Medicine ◽

10.1093/pm/pny303 ◽

2019 ◽

Vol 20 (9) ◽

pp. 1745-1749 ◽

Cited By ~ 5

Author(s):

Tannaz Ahadi ◽

Maryam Esmaeili Jamkarani ◽

Gholam Reza Raissi ◽

Korosh Mansoori ◽

Seyede Zahra Emami Razavi ◽

...

Keyword(s):

Shock Wave ◽

Clinical Trial ◽

Grip Strength ◽

Group Analysis ◽

Extracorporeal Shock Wave Therapy ◽

Shock Wave Therapy ◽

Short Term ◽

Extracorporeal Shock Wave ◽

Quick Dash ◽

Lateral Epicondylosis

Abstract Objective The aim of this study was to compare the efficacy of prolotherapy with hypertonic dextrose and radial shock wave therapy in chronic lateral epicondilosis. Design Prospective single-blind randomized clinical trial. Setting Physical medicine and rehabilitation clinic. Subjects Thirty-three patients with at least three months of signs and symptoms of lateral epicondilosis, as well as failure of at least one of the conservative treatments, randomly allocated into two groups. Methods Sixteen patients received three sessions of shock wave therapy, and 17 received one session prolotherapy. Severity of pain via visual analog scale (VAS), grip strength via Baseline Pneumatic Dynamometer, pressure pain threshold (PPT) by algometer and Disabilities of Arm, Shoulder, and Hand quick questionnaire (Quick DASH) were assessed at baseline, four weeks, and eight weeks after the intervention. Results Within-group analysis showed that in both groups, differences between all of the outcome measures were significant after four and also eight weeks. Between-group analysis after four and eight weeks showed that the VAS and Quick DASH had significantly more improvement in the shock wave group. However, the two groups were similar regarding grip strength and PPT. No complication was observed in the two groups. Conclusions Based on the results of this study, a regiment of three sessions (weekly) of radial extracorporeal shock wave therapy is significantly more effective than one session of prolotherapy with 20% dextrose regarding pain and function in the management of chronic lateral epicondylosis in short-term follow-up.

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Mid-Term Results of the Use of a Suture Anchor Fixation for Chronic Reducible Scapholunate Dissociation

The Journal of Hand Surgery (Asian-Pacific Volume) ◽

10.1142/s2424835519500565 ◽

2019 ◽

Vol 24 (04) ◽

pp. 440-446

Author(s):

Reza Shahryar Kamrani ◽

Behnam PanjaviLee ◽

Ehsan Vahedi

Keyword(s):

Grip Strength ◽

Suture Anchor ◽

Dash Score ◽

Scapholunate Dissociation ◽

Tissue Manipulation ◽

Quick Dash ◽

Suture Anchor Fixation ◽

Anchor Fixation ◽

Mid Term Results

Background: Scapholunate dissociation (SLD) is a common and sometimes disabling ligamentous injury of the wrist. The aim of the treatment is to restore carpal alignment and to prevent joint degeneration. In the current study, we reported mid-term results of our technique using suture anchor fixation within the SL interface. Methods: Nine male patients with an average age of 35 years underwent scapholunate suture anchor fixation (SLAF) for chronic and symptomatic dynamic or reducible static SLD from 2011 to 2016 with a mean follow-up of 36 months. After dorsal wrist exposure, a 2.8 mm suture anchor was inserted in the dorsoproximal lateral articular surface of the lunate bone. The two ends of the sutures were passed through the two divergent canals in the scaphoid. The sutures were tied over the tuberosity after reducing the SL alignment. Two K-wires supported SL and scaphocapitate (SC) alignment for 8 weeks. Radiographic parameters, wrist range of motion and grip strength were measured. Quick-DASH and Modified Mayo Wrist Score (MMWS) were used to assess the functional outcome. Results: The grip strength and passive motion reached to 75% and 88% of the other side, respectively. The SL gap was 5.4 mm, 2.6 mm and 3.4 mm before surgery, after pin removal, and on the follow-up stress radiographs, respectively. The SL angle was 82, 52 and 65 degrees at any time point, respectively. Average Quick-DASH score was improved from 60 to 25. According to MMWS score, one patient was excellent, one was good, five were fair, and two were poor. Conclusions: SLAF is a simple technique with minimal soft tissue manipulation that enables correction and maintaining of the carpal alignment with favorable mid-term results.

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Use of the Bridge Plate Technique for the Treatment of Hamatometacarpal Fracture-Dislocations

The Journal of Hand Surgery (Asian-Pacific Volume) ◽

10.1142/s2424835520500095 ◽

2020 ◽

Vol 25 (01) ◽

pp. 67-75 ◽

Cited By ~ 2

Author(s):

Hyoung-Seok Jung ◽

Min Ku Song ◽

Jae-Sung Lee

Keyword(s):

Grip Strength ◽

Wrist Joint ◽

Joint Stiffness ◽

Metacarpophalangeal Joint ◽

Dash Score ◽

Strength Data ◽

Plate Technique ◽

Bridge Plate ◽

Fracture Dislocations ◽

Quick Dash

Background: This study aimed to describe a novel surgical technique in which a bridge plate was used for the treatment of hamatometacarpal fracture-dislocations and to assess its radiologic and clinical outcomes. Methods: A retrospective review of 16 patients treated with the bridge plate technique for hamatometacarpal fracture-dislocations was performed between 2010 and 2015. Clinical and radiographic evaluations were performed at months 3, 6, and 12 postoperatively. Active wrist and metacarpophalangeal joint ranges of motion and Quick Disabilities of Arm, Shoulder, and Hand (DASH) scores were recorded for the injured hands. Grip strength data were collected for both the injured hands and the contralateral uninjured hands. Results: All patients included in our study were male (mean age 31 years). The average Quick DASH score was 24.3 ± 9.1 at 3 months, 12.3 ± 7.3 at 6 months, and 6.2 ± 6.6 at 12 months. All patients returned to their original jobs within 5 weeks of the procedure. Grip strength eventually recovered to 90% of that of the uninjured hand, and none of the patients complained of finger or wrist joint stiffness. Conclusions: The use of the bridge plate technique may be an effective alternative treatment for patients with comminuted hamatometacarpal fracture-dislocations.

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Feasibility of Heavy Slow Resistance Training in patients with subacromial shoulder pain. A single-blind, randomized pilot study.

10.21203/rs.2.20336/v2 ◽

2020 ◽

Author(s):

Elisabeth Kvalvaag ◽

Hans Hugo Fredriksen Høiland ◽

Marianne Bakke Johnsen ◽

Jens Ivar Brox ◽

Kaia Beck Engebretsen ◽

...

Keyword(s):

Pilot Study ◽

Resistance Training ◽

Sample Size ◽

Shoulder Pain ◽

Small Sample Size ◽

Linear Regression Analysis ◽

Pilot Trial ◽

Small Sample ◽

Dash Score ◽

Home Training

Abstract Background: Subacromial shoulder pain is the most common shoulder diagnosis, and should preferably be treated non-operatively. Previous studies have shown promising results of Heavy Slow Resistance training (HSR) in patellar and Achilles tendinopathy, but few studies have evaluated the effect of HSR for shoulder pain. The purpose of this pilot trial was to evaluate if HSR training is feasible for patients with subacromial shoulder pain, and to compare HSR to traditional supervised exercises. Methods: Twenty-two patients with subacromial shoulder pain lasting at least three months were recruited and randomized to HSR (n=11) or traditional supervised exercises (n=11) by computer-generated randomization in blocks of four. Patients received HSR once a week, in addition to home-training twice a week, or supervised exercises twice a week for 12 weeks, in addition to daily home-training. The primary outcome measure was the Shoulder Pain and Disability Index (SPADI). Linear regression analysis was applied to evaluate the between group differences after 12 weeks. Outcome assessors were masked. Results: After 12 weeks, patients in both groups had improved significantly from baseline in SPADI score (P=0.001) but no group difference was found (mean difference 1.3; 95% CI, -21.9 to 24.5, P=0.91). Similar non-significant results between groups were seen for pain in activity and rest, and the DASH score. Conclusion: This pilot-study observed similar results of HSR compared to supervised exercises for patients with subacromial shoulder pain and both groups improved significantly from baseline. Only one patient changed from HSR to supervised exercises due to increased pain. Based on this, HSR appears to be a feasible treatment for this patient group, but due to small sample size there is a risk of type II error and studies with larger sample size are required.

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Ligament Reconstruction of Traumatic Pure Dislocation of Carpometacarpal Joint of the Thumb: A Series of Acute and Chronic Cases

Journal of Hand and Microsurgery ◽

10.1055/s-0040-1718789 ◽

2020 ◽

Vol 12 (S 01) ◽

pp. S16-S20

Author(s):

Farid Najd Mazhar ◽

Davod Jafari ◽

Seyed Sajjad Jafari ◽

Alireza Mirzaei

Keyword(s):

Grip Strength ◽

Outcome Measures ◽

Ligament Reconstruction ◽

Reconstruction Technique ◽

Reconstruction Method ◽

Dash Score ◽

The Mean ◽

Quick Dash ◽

Cmc Joint

Abstract Background Traumatic instability of carpometacarpal (CMC) joint of the thumb without a fracture (pure dislocation of CMC joint) is an uncommon injury, and a universally accepted protocol has not yet been developed for its management. Here, we aim to evaluate the outcome of this injury managed with ligament reconstruction technique, in a series of acute and chronic injuries. Patients and Methods Total nine patients (six acute and three chronic) with pure dislocation of CMC joint who underwent ligament reconstruction surgery were included in this retrospective study. Outcome measures included disabilities of the arm, shoulder, and hand (quick-DASH) questionnaire; visual analog scale (VAS) scoring system; patient-rated wrist/hand evaluation (PRWHE) system; pinch and grip strength; and Kapandji thumb opposition scores. Results The patients’ mean age was 32.55 ± 11.4 years. Their mean follow-up period was 27 ± 12.8 months. The mean postoperative pinch and grip strength was equivalent to 91.5% and 108% of the contralateral hand, respectively. The mean Quick-DASH score was 14.7 ± 19.4. The mean PRWHE score was 18.7 ± 22.4. The mean VAS was 1.1 ± 1.5. The mean Kapandji score was 8.3 ± 1.4. The pinch and grip strength were considerably superior in acute injuries. Degenerative changes were seen in all joints at the latest follow-up. None of our patients needed a revision surgery. Conclusion Ligament reconstruction method could result in favorable outcome in the management of pure dislocation of CMC joint. However, delayed surgery of this injury might adversely affect the outcome measures.

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Planning the Size of Clinical Trials with Allowance for Patient Noncompliance

Methods of Information in Medicine ◽

10.1055/s-0038-1634787 ◽

1990 ◽

Vol 29 (03) ◽

pp. 243-246 ◽

Cited By ~ 2

Author(s):

M. A. A. Moussa

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Sample Size ◽

Event Rate ◽

Survival Functions ◽

Time Intervals ◽

Patient Noncompliance ◽

Event Rates ◽

Larger Sample

AbstractVarious approaches are considered for adjustment of clinical trial size for patient noncompliance. Such approaches either model the effect of noncompliance through comparison of two survival distributions or two simple proportions. Models that allow for variation of noncompliance and event rates between time intervals are also considered. The approach that models the noncompliance adjustment on the basis of survival functions is conservative and hence requires larger sample size. The model to be selected for noncompliance adjustment depends upon available estimates of noncompliance and event rate patterns.

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A proximal interphalangeal joint custom-made orthosis in trigger finger: Functional outcome

Hand Therapy ◽

10.1177/17589983211018717 ◽

2021 ◽

pp. 175899832110187

Author(s):

Kawee Pataradool ◽

Chayanin Lertmahandpueti

Keyword(s):

Outcome Measures ◽

Proximal Interphalangeal Joint ◽

Interphalangeal Joint ◽

Mean Difference ◽

Trigger Finger ◽

Symptom Improvement ◽

Dash Score ◽

Full Time ◽

Custom Made ◽

Quick Dash

Introduction Trigger finger is a common and functionally limiting disorder. Finger immobilization using an orthotic device is one of the conservative treatment options for treating this condition. The most common orthosis previously described for trigger finger is metacarpophalangeal joint immobilization. There are limited studies describing the effectiveness of proximal interphalangeal joint orthosis for treatment of trigger finger. Methods This study was a single group pretest-posttest design. Adult patients with single digit idiopathic trigger finger were recruited and asked to wear a full-time orthoses for 6 weeks. The pre- and post-outcome measures included Quick-DASH score, the Stages of Stenosing Tenosynovitis (SST), the Visual Analogue Scale (VAS) for pain, the number of triggering events in ten active fists, and participant satisfaction with symptom improvement. Orthotic devices were made with thermoplastic material fabricated with adjustable Velcro tape at dorsal side. All participants were given written handouts on this disease, orthotic care and gliding exercises. Paired t-tests were used to determine changes in outcome measures before and after wearing the orthosis. Results There were 30 participants included in this study. Evaluation after the use of PIP joint orthosis at 6 weeks revealed that there were statistically significant improvements in Quick-DASH score from enrolment (mean difference −29.0 (95%CI −34.5 to −23.4); p < 0.001), SST (mean difference −1.4 (95%CI −1.8 to −1.0); p < 0.001) and VAS (mean difference −3.4 (95%CI −4.3 to −2.5); p < 0.001). There were no serious adverse events and patient satisfaction with the treatment was high. Conclusions Despite our small study size, the use of proximal interphalangeal joint orthosis for 6 weeks resulted in statistically significant improvements in function, pain and triggering, and also high rates of acceptance in patients with isolated idiopathic trigger finger.

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