Effect of a Thin Customized Insole in RA

Rheumatoid Arthritis Clinical Trial

Official title:

Effect of a Thin Customized Insole on Pain and Walking Ability in Rheumatoid Arthritis: A Randomised Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02964156
• Other study ID #: Revma nr 6
• Status: Completed
• Phase: N/A
• First received: December 23, 2013
• Last updated: November 10, 2016
• Start date: May 2011
• Est. completion date: April 2014

Study information

• Verified date: November 2016
• Source: Revmatismesykehuset AS
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research EthicsNorway: Data Protection Authority
• Study type: Interventional

Clinical Trial Summary

50-90% of patients with RA reports foot problems and the metatarsophalangeal joints of the forefoot are most frequently afflicted. Studies shows that foot problems can influence negatively on the walking function, physical activity and quality of life. Different foot orthoses and insoles are used as an intervention. Studies find that different insoles do have effect on pain, but there are no or minor effect on walking ability. The literature reports a further need for research and indicates the importance of studies on the effects of cost-effective insoles for patients with RA.

Custom-built insoles takes time and are often expensive, and many patients, especially women, do not wear them since they often do not fit the shoes they prefer to wear. In this study, a 4-mm thin, flat insole of a malleable plastic material (CI-Core®) with synthetic textile material on the upper side is customized to provide support for the transverse and longitudinal arches of the foot to reduce pressure on painful joints. The insole is easily customized and ready for use the same day. The purpose of this study was to determine whether this insole can reduce foot pain and increase walking distance in patients with RA and forefoot pain.

An experimental study was performed on patients with RA and forefoot pain in either one or both feet. The patients walked as fast as they could in 6 minutes (6MWT) with either insoles (situation A) and without insoles (situation B). The order of situation A and B was randomized, and the assessor was blinded for the order of the two situations. Both tests were conducted the same day. After each test round, the patient was asked to register pain in the foot and perceived exertion. A telephone interview was conducted one year after the effect study to examine whether the insoles were still being used.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: April 2014
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis Rheumatoid Arthritis

• Foot pain while walking

• Positive Gaenslens sign in forefoot

• Native Norwegian speaking

Exclusion Criteria:

• Cognitive dysfunction

• Problems reading

• Problems in walking due to problems han the foot such as in ankel, knee or hip

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Other:
• Supersole
A 4-mm thin, individually customized insole of a malleable plastic material (CI-Core®) with synthetic textile material on the upper side.
• No intervention
No intervention

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Revmatismesykehuset AS

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain intensity measured using Visual Analog Scale (VAS)	Pain is measured using Visual Analog Scale (VAS)	Change between test situation A and B (or B and A). A: Walking test using insoles. B. Walking test not using insoles. There is a 20 minute break between the two situations.	No
Primary	Walking ability measured using the 6-minute walking test	Walking ability is measured using the 6-minute walking test	Change between test situation A and B (or B and A). A: Walking test using insoles. B. Walking test not using insoles. There is a 20 minute break between the two situations.	No
Secondary	perceived exertion measured using Borg CR10 scale	Perceived exertion is measured using Borg category ratio scale (Borg CR10)	Change between test situation A and B (or B and A). A: Walking test using insoles. B. Walking test not using insoles. There is a 20 minute break between the two situations.	No