Insole effectiveness investigation
Research type
Research Study
Full title
An open-label, single-centre, parallel-group clinical investigation, to evaluate the effectiveness and in-use tolerability of a range of four orthotic insoles on target areas of pain in the lower body, associated with musculoskeletal stress, experienced by those who spend most of their working day on their feet
IRAS ID
248459
Contact name
Gordon Crawford
Contact email
Sponsor organisation
Reckitt Benckiser Healthcare UK
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 9 months, days
Research summary
This is an open-label, single-centre, parallel-group clinical investigation, to evaluate the effectiveness and in-use tolerability of a range of four orthotic insoles on target areas of pain in the lower body, associated with musculoskeletal
stress.
These insoles have been designed to help relieve pain located in in the feet or lower body experienced by those who spend most of their working day of their feet. The aim of the investigation is to find out if the insoles are effective in
reducing this pain, and also to assess how well the insoles are tolerated.
Approximately 80 participants per insole type, resulting in 320 participants in total, will be included in this investigation at one research centre in Scotland. This investigation will recruit healthy men and women aged 18 to 67 years (both
inclusive) with shoe size between 4.5 and 11 (both inclusive), who spend most of their working day on their feet.
Eligible participants would wear one type of insole that aims to relieve the pain in an area they have problems with. In the first part of the investigation, participants will fill out questionnaires on a daily basis to record their pain and wellbeing without the specific insole. In the second part, they will wear the insole relevant to their pain area and continue to record their pain and well-being in questionnaires to see if the insoles improve their condition.
The four different insoles each target a different area of pain. The assigned insoles will be fitted by a physiotherapist during their visit at the research centre.
There is a Declaration of Conformity (CE mark) in place for each of the insoles, which is a formal declaration by the manufacturer (RB) that the product has been designed and constructed in compliance with all relevant requirements.
This investigation will take approximately 7 to 9 weeks.REC name
East of Scotland Research Ethics Service REC 1
REC reference
19/ES/0033
Date of REC Opinion
29 Apr 2019
REC opinion
Further Information Favourable Opinion