Insoles Effect on Pain and Daily Activities

Study Overview
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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.

Official Title
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The Effect of Shoe Insoles on Pain and Daily Activities and the Relation Between Satisfaction With Insoles and Use: A pre-and Post-intervention Survey

Conditions
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Non-specific Pain in Lower Extremities

Intervention / Treatment
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* Device: Shoe Insoles


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Single-arm study<br>This is a single-arm study. Just one group (i.e. the patients) | Device: Shoe Insoles<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Shoe insoles effect on pain level in lower extremities. | The participants answer the inetial questioniners before getting the insoles, then answr the same questionnier after four weeks of insoles use. | Four-weeks follwo up period | 
| Shoe insoles effect on daily activities | The participants answer Inetnational Physical Activty Questionnier (IPAQ)and Lower Extremity Functional Status (LEFS)before getting the insoles and after four weeks of use. | Four-weeks follow up period | 
| Satisfaction with shoe insoles use | Client Satisfaction with Device(CSD)survey was anwered by the participants after four weeks of use. | After four weeks of use | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Orthotic Devices, Activities of Daily Living, Pain Measurement, Lower Extremity, Foot, Personal Satisfaction