Biomedical subjects

Katie Dainty

Publications and source records attributed to Katie Dainty.

5 recordsLinked to original sources

PubMed2006

Randomized, placebo-controlled, double-blind clinical trial evaluating the treatment of plantar fasciitis with an extracoporeal shockwave therapy (ESWT) device: a North American confirmatory study.

Despite numerous publications and clinical trials, the results of treatment of recalcitrant chronic plantar fasciitis with extracorporeal shockwave therapy (ESWT) still remain equivocal as to whether or not this treatment provides relief from the pain associated with this condition. The objective of this study was to determine whether extracorporeal shock wave therapy can safely and effectively relieve the pain associated with chronic plantar fasciitis compared to placebo treatment, as demonstrated by pain with walking in the morning. This was set in a multicenter, randomized, placebo-controlled, double-blind, confirmatory clinical study undertaken in four outpatient orthopedic clinics. The patients, 114 adult subjects with chronic plantar fasciitis, recalcitrant to conservative therapies for at least 6 months, were randomized to two groups. Treatment consisted of approximately 3,800 total shock waves (+/-10) reaching an approximated total energy delivery of 1,300 mJ/mm(2) (ED+) in a single session versus placebo treatment. This study demonstrated a statistically significant difference between treatment groups in the change from baseline to 3 months in the primary efficacy outcome of pain during the first few minutes of walking measured by a visual analog scale. There was also a statistically significant difference between treatments in the number of participants whose changes in Visual Analog Scale scores met the study definition of success at both 6 weeks and 3 months posttreatment; and between treatment groups in the change from baseline to 3 months posttreatment in the Roles and Maudsley Score. The results of this study confirm that ESWT administered with the Dornier Epos Ultra is a safe and effective treatment for recalcitrant plantar fasciitis.

Activities of Daily Living↗

PubMed2003

Considerations on sample size and power calculations in randomized clinical trials.

Many studies in orthopaedics and sports medicine have not considered sample size or statistical power as important issues in study design. This article addresses the importance of a sample size calculation in randomized clinical trials and the components of the calculations that researchers must consider in their preliminary planning of an investigation. The types of data being collected, level of significance, types I and II errors, and power are also addressed.

Humans↗

PubMed2003

Practical aspects of randomization and blinding in randomized clinical trials.

Randomization and blinding are important tools in determining the effectiveness of a new intervention and ensuring the validity of a clinical trial. However, randomness and haphazardness are not equivalent. Randomization cannot overcome poor experimental design or technique. Several types of randomization including historical controls and pseudorandomization are discussed, as well as methods of treatment allocation, stratification, and minimization techniques. The importance of decreasing bias and the advantages and disadvantages of blinding in randomized clinical trials are also covered.

Bias↗

PubMed2003

Scoring systems for the functional assessment of the shoulder.

A number of instruments have been developed to measure the quality of life in patients with various conditions of the shoulder. Older instruments appear to have been developed at a time when little information was available on the appropriate methodology for instrument development. Much progress has been made in this area, and currently an appropriate instrument exists for each of the main conditions of the shoulder. Investigators planning clinical trials should select modern instruments that have been developed with appropriate patient input for item generation and reduction, and established validity and reliability. Among the other factors discussed in this review, responsiveness of an instrument is an important consideration as it can serve to minimize the sample size for a proposed study. The shoulder instruments reviewed include the Rating Sheet for Bankart Repair (Rowe), ASES Shoulder Evaluation Form, UCLA Shoulder Score, The Constant Score, Disabilities of the Arm, Shoulder and Hand (DASH), the Shoulder Rating Questionnaire, the Simple Shoulder Test (SST), the Western Ontario Osteoarthritis of the Shoulder Index (WOOS), the Western Ontario Rotator Cuff Index (WORC), the Western Ontario Shoulder Instability Index (WOSI), Rotator Cuff Quality of Life (RC-QOL), and the Oxford Shoulder Scores (OSS).

Humans↗

PubMed2003

Factors to consider in determining the feasibility of randomized clinical trials.

This article briefly reviews some of the important feasibility issues to be considered, and often overlooked, prior to undertaking clinical research. Topics such as time requirements, the multidisciplinary approach, the importance of a Clinical Research Coordinator, training of personnel, enrollment issues, funding, and the intrinsic and extrinsic benefits of conducting clinical research are discussed.

Humans↗