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Completed

NCT Number: NCT01640899

Insoles Effect on Pain and Daily Activities

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.

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Key information

Conditions

Non-specific Pain in Lower Extremities Behavior Personal Satisfaction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dept. of Prosthetics and Orthotics, Orebro University Hospital

Örebro, Örebro County, 701 85, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Shoe Insoles

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.

Primary outcomes

  1. Shoe insoles effect on pain level in lower extremities.

    Time frame: 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.

  2. Shoe insoles effect on daily activities

    Time frame: 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.

  3. Satisfaction with shoe insoles use

    Time frame: After four weeks of use

    Client Satisfaction with Device(CSD)survey was anwered by the participants after four weeks of use.

Sponsors and collaborators

Lead sponsor

Centre for Rehabilitation Research, Örebro

Other Gov

Collaborators

  • Örebro County Council

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jul 16, 2012
Registry last updated
Jul 16, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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