Insoles Effect on Pain and Daily Activities

Not Applicable

Completed

• Conditions: Non-specific Pain in Lower Extremities
• Interventions: Device: Shoe Insoles

• Registration Number: NCT01640899
• Lead Sponsor: Centre for Rehabilitation Research, Örebro

Brief Summary

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

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.

Study Timeline

• Study Start: 2010-08
• Primary Completion: 2011-01
• Study Completion: 2011-11
• Status Verified: 2012-07
• Study First Submitted: 2012-07-12
• Study First Submitted QC: 2012-07-12
• Last Update Submitted: 2012-07-12
• Study First Posted: 2012-07-16
• Last Update Posted: 2012-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 89

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single-arm study	Shoe Insoles	This is a single-arm study. Just one group (i.e. the patients)

Primary Outcome Measures

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

Trial Locations

Locations (1)

Dept. of Prosthetics and Orthotics, Orebro University Hospital; 🇸🇪 Orebro, Orebro County, Sweden