Insoles Effect on Pain and Daily Activities

Non-specific Pain in Lower Extremities Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01640899
• Other study ID #: CRR120709
• Status: Completed
• Phase: N/A
• First received: July 12, 2012
• Last updated: July 12, 2012
• Start date: August 2010
• Est. completion date: November 2011

Study information

• Verified date: July 2012
• Source: Centre for Rehabilitation Research, Örebro
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: November 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Non-specific Pain in Lower Extremities

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Sweden	Dept. of Prosthetics and Orthotics, Orebro University Hospital	Orebro	Orebro County

Sponsors (2)

Lead Sponsor	Collaborator
Centre for Rehabilitation Research, Örebro	Örebro County Council

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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