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
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring RA, Insole, Forefoot, Walking Ability, Pain
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
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
NCT ID
NCT02964156
First Posted
December 23, 2013
Last Updated
November 10, 2016
Sponsor
Revmatismesykehuset AS
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
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Effect of a Thin Customized Insole in RA
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