Insoles Effect on Pain and Daily Activities

NCT ID: NCT01640899

Last Updated: 2012-07-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

89 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2011-11-30

Brief Summary

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The aims of this study were to evaluate the effects of insoles on pain, daily activities and physical activity level, and to investigate the relation between satisfaction with the insoles and their actual use in individuals with LE pain.

Detailed Description

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Pain in weight-bearing joints limits individual's function and ability to perform daily activities, causes a negative effect on productivity and increased costs for social insurance. This pain is often the outcome of structural deformities or work-related foot pain often occurs in workers whose occupations include standing or walking for a long time.

One of the most common reasons for prescribing insoles is to enhance functioning by reducing nonspecific pain in the foot, leg or low back pain. Reduction of pain is expected to improve quality of life in daily activities such as work and recreational activities.

Persons actual use of the insoles, is a prerequisite for any effect it may have. It can be hypothesized that the use of the insoles is related to what the user thinks about their comfort, appearance, the amount of foot perspiration they induce, and other factors.

Conditions

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Non-specific Pain in Lower Extremities

Keywords

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Orthotic Devices Activities of Daily Living Pain Measurement Lower Extremity Foot Personal Satisfaction

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single-arm study

This is a single-arm study. Just one group (i.e. the patients)

Group Type OTHER

Shoe Insoles

Intervention Type DEVICE

Shoe insoles is an orthotic devices which are used to prevent, relieve, or reduce pain in lower extremities. The insoles give a mechanical support for the body by put it in a good alignment.

Interventions

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Shoe Insoles

Shoe insoles is an orthotic devices which are used to prevent, relieve, or reduce pain in lower extremities. The insoles give a mechanical support for the body by put it in a good alignment.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Pain in lower extremities
* Aged 18 years or older
* Able to speak Swedish.

Exclusion Criteria

* Pain due to a systemic or progressive disease
* Use of orthosis of other type than insoles
* Earlier foot surgery or current use of prosthesis.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Örebro County Council

OTHER_GOV

Sponsor Role collaborator

Centre for Rehabilitation Research, Örebro

OTHER_GOV

Sponsor Role lead

Responsible Party

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Ahmed Amer

Research Assisstant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ahmed Amer, Master

Role: PRINCIPAL_INVESTIGATOR

Centre for Rehabilitation Reserach, Örebro

Liselotte Norling-Hermansson, PhD

Role: STUDY_DIRECTOR

Dept. of Prosthetics and Orthotics, Örebro University Hospital, Örebro

Locations

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Dept. of Prosthetics and Orthotics, Orebro University Hospital

Örebro, Örebro County, Sweden

Site Status

Countries

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Sweden

Related Links

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Other Identifiers

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CRR120709

Identifier Type: -

Identifier Source: org_study_id