Effect of a Thin Customized Insole in RA

NCT02964156 | Completed DMC

• 1 other identifier: Revma nr 6
• Study Type: interventional
• Target: 21
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Rheumatoid Arthritis

Keywords

RA; Insole; Forefoot; Walking Ability; Pain

Outcome Measures

Primary Outcomes (2)

• 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.

• 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.

Secondary Outcomes (1)

• perceived exertion measured using Borg CR10 scale

  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.

Study Arms (2)

Walking test using insoles

EXPERIMENTAL

Supersole

Other: Supersole

Walking test not using insoles

EXPERIMENTAL

no intervention

Other: No intervention

Interventions

Supersole OTHER

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

Walking test using insoles

No intervention OTHER

No intervention

Walking test not using insoles

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis Rheumatoid Arthritis
• Foot pain while walking
• Positive Gaenslens sign in forefoot
• Native Norwegian speaking

You may not qualify if:

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

Sponsors & Collaborators

• Revmatismesykehuset AS: lead

MeSH Terms

Conditions

Arthritis, Rheumatoid; Pain

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Knut Mikkelsen, MD

  Revmatismesykehuset AS, Lillehammer, Norway

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2013
• First Posted: November 16, 2016
• Study Start: May 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: April 1, 2014
• Last Updated: November 16, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share