Insoles Effect on Pain and Daily Activities

Centre for Rehabilitation Research, Örebro

Status: Completed

Conditions: Non-specific Pain in Lower Extremities

Treatments: Device: Shoe Insoles

Study type: Interventional

Funder types: Other

Identifiers

NCT01640899

CRR120709

Details and patient eligibility

About

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.

Full 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.

Enrollment: 89 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

89 participants in 1 patient group

Single-arm study

Other group

Description:

This is a single-arm study. Just one group (i.e. the patients)

Treatment:

Device: Shoe Insoles