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

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.

Study Overview

• Status: Completed
• Conditions: Non-specific Pain in Lower Extremities
• Intervention / Treatment: Device: Shoe Insoles

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 Type: Interventional
• Enrollment (Actual): 89
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Orebro County
    • Orebro, Orebro County, Sweden, 701 85
      • Dept. of Prosthetics and Orthotics, Orebro University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Single-arm study; This is a single-arm study. Just one group (i.e. the patients)	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centre for Rehabilitation Research, Örebro
• Collaborators: Örebro County Council
• Investigators: Principal Investigator: Ahmed Amer, Master, Centre for Rehabilitation Reserach, Örebro; Study Director: Liselotte Norling-Hermansson, PhD, Dept. of Prosthetics and Orthotics, Örebro University Hospital, Örebro

Publications and helpful links

Helpful Links

• Information about the study (In Swedish)

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Actual): January 1, 2011
• Study Completion (Actual): November 1, 2011

Study Registration Dates

• First Submitted: July 12, 2012
• First Submitted That Met QC Criteria: July 12, 2012
• First Posted (Estimate): July 16, 2012

Study Record Updates

• Last Update Posted (Estimate): July 16, 2012
• Last Update Submitted That Met QC Criteria: July 12, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Keywords: Activities of Daily Living; Lower Extremity; Foot; Orthotic Devices; Pain Measurement; Personal Satisfaction
• Other Study ID Numbers: CRR120709