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Insoles Effect on Pain and Daily Activities

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01640899
Enrollment
89
Registered
2012-07-16
Start date
2010-08-31
Completion date
2011-11-30
Last updated
2012-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-specific Pain in Lower Extremities

Keywords

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

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.

Interventions

DEVICEShoe 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.

Sponsors

Örebro County Council
CollaboratorOTHER_GOV
Centre for Rehabilitation Research, Örebro
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Shoe insoles effect on pain level in lower extremities.Four-weeks follwo up periodThe 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 activitiesFour-weeks follow up periodThe 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 useAfter four weeks of useClient Satisfaction with Device(CSD)survey was anwered by the participants after four weeks of use.

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026