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Completed

NCT Number: NCT02964156

Effect of a Thin Customized Insole in RA

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.

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Key information

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Supersole

Other

A 4-mm thin, individually customized insole of a malleable plastic material (CI-Core®) with synthetic textile material on the upper side.

No intervention

Other

No intervention

Primary outcomes

  1. Pain intensity measured using Visual Analog Scale (VAS)

    Time frame: 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.

    Pain is measured using Visual Analog Scale (VAS)

  2. Walking ability measured using the 6-minute walking test

    Time frame: 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.

    Walking ability is measured using the 6-minute walking test

Secondary outcomes

  1. perceived exertion measured using Borg CR10 scale

    Time frame: 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.

    Perceived exertion is measured using Borg category ratio scale (Borg CR10)

Sponsors and collaborators

Lead sponsor

Revmatismesykehuset AS

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2014
First posted
Nov 16, 2016
Registry last updated
Nov 16, 2016

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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