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Effect of a Thin Customized Insole in RA

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Supersole
No intervention
Sponsored by
Revmatismesykehuset AS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring RA, Insole, Forefoot, Walking Ability, Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Walking test using insoles

    Walking test not using insoles

    Arm Description

    Supersole

    no intervention

    Outcomes

    Primary Outcome Measures

    Pain intensity measured using Visual Analog Scale (VAS)
    Pain is measured using Visual Analog Scale (VAS)
    Walking ability measured using the 6-minute walking test
    Walking ability is measured using the 6-minute walking test

    Secondary Outcome Measures

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

    Full Information

    First Posted
    December 23, 2013
    Last Updated
    November 10, 2016
    Sponsor
    Revmatismesykehuset AS
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02964156
    Brief Title
    Effect of a Thin Customized Insole in RA
    Official Title
    Effect of a Thin Customized Insole on Pain and Walking Ability in Rheumatoid Arthritis: A Randomised Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2011 (undefined)
    Primary Completion Date
    December 2012 (Actual)
    Study Completion Date
    April 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Revmatismesykehuset AS

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Rheumatoid Arthritis
    Keywords
    RA, Insole, Forefoot, Walking Ability, Pain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    21 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Walking test using insoles
    Arm Type
    Experimental
    Arm Description
    Supersole
    Arm Title
    Walking test not using insoles
    Arm Type
    Experimental
    Arm Description
    no intervention
    Intervention Type
    Other
    Intervention Name(s)
    Supersole
    Intervention Description
    A 4-mm thin, individually customized insole of a malleable plastic material (CI-Core®) with synthetic textile material on the upper side.
    Intervention Type
    Other
    Intervention Name(s)
    No intervention
    Intervention Description
    No intervention
    Primary Outcome Measure Information:
    Title
    Pain intensity measured using Visual Analog Scale (VAS)
    Description
    Pain is 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.
    Title
    Walking ability measured using the 6-minute walking test
    Description
    Walking ability is 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.
    Secondary Outcome Measure Information:
    Title
    perceived exertion measured using Borg CR10 scale
    Description
    Perceived exertion is measured using Borg category ratio scale (Borg CR10)
    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.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Knut Mikkelsen, MD
    Organizational Affiliation
    Revmatismesykehuset AS, Lillehammer, Norway
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Effect of a Thin Customized Insole in RA

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