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Effectiveness of Four Orthotic Insoles on Pain in the Lower Body Associated With Musculoskeletal Stress

NCT04746755 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 145

Last updated 2021-02-10

No results posted yet for this study

Summary

This was 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

Conditions

Interventions

DEVICE

Orthotic Insole: Lower Back

This Insole is a full-length shaped orthotic insole, with a heel cup and an arch support. The insole can cover several shoe sizes and can be cut to the correct size to fit in the shoe.

DEVICE

Orthotic Insole: Heel

This Insole is a horseshoe shaped flexible heel cup with a softer area where the heel would be expected.

DEVICE

Orthotic Insole: Knee to Heel

This Insole is a ¾ length rigid orthotic insole with a softer area where the heel would be expected. Each insole will cover several shoe sizes.

DEVICE

Orthotic Insole: Arch

This Insole is a ¾ length shaped medical device with a softer area incorporated into the ball of foot and heel area and an external arch. support and 6-8 mm metatarsal dome. The slim fit insole runs from the heel along under the arch of the foot and reaches to just behind the toes to prevent squashing the toes in tight fitting shoes.

Sponsors & Collaborators

  • SynteractHCR Deutschland GmbH

    collaborator UNKNOWN

  • Reckitt Benckiser Healthcare (UK) Limited

    lead INDUSTRY

Principal Investigators

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-06-21
Primary Completion
2019-12-16
Completion
2020-03-05

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04746755 on ClinicalTrials.gov