Identification of forefoot pain using a novel expert derived protocol
Research type
Research Study
Full title
The content validity and reliability of an expert derived clinical protocol for the identification of forefoot neuroma.
IRAS ID
178150
Contact name
Catherine Bowen
Contact email
Sponsor organisation
University of Southampton
Duration of Study in the UK
0 years, 10 months, 31 days
Research summary
Forefoot neuroma is a benign tumor that alters sensation in between the toes. Sometimes this can be painful to those individuals who have this condition. Currently, we do not know how common this condition is within a population although women are more likely to be diagnosed compared to men. The reason why this condition occurs is also unknown. The problem is more complicated because there are no guidelines to help clinicians diagnose this condition. Therefore the aim of this research study is to test a novel clinical assessment protocol to ensure it represents the facets of forefoot neuroma diagnosis (content validity) in addition to determining its reliability to diagnose forefoot neuroma in clinical practice.
The study seeks to determine how accurate the novel clinical assessment protocol is at identifying forefoot neuroma from other conditions. The study also seeks to determinate consistency of the novel clinical assessment protocol when methods are repeated by the same researcher. To do this, potential participants (patients) with forefoot pain will be invited to attend a research appointment to conduct the novel clinical assessment protocol in clinical practice. A second researcher will use an ultrasound machine to scan both soles of the feet to identify if a neuroma is present or absent. Using the data collected, with a series of calculations, it is hoped that the novel clinical assessment protocol is reliable in diagnosing forefoot neuroma with appropriate levels of content validity.
REC name
East Midlands - Nottingham 1 Research Ethics Committee
REC reference
16/EM/0268
Date of REC Opinion
16 Jun 2016
REC opinion
Favourable Opinion