NCT01765101

Brief Summary

Using double blind, randomized controlled design to study the immediate, short-term and intermediate-term therapeutic effects of ready-made full-length lateral wedged shoe insoles and customized full-length lateral wedged shoe insoles to patients with knee osteoarthritis, under the basis of International Classification Functioning, Disability and Health.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at below P25 for phase_3 knee-osteoarthritis

Timeline
Completed

Started Jan 2013

Shorter than P25 for phase_3 knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

January 4, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 10, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

January 11, 2013

Status Verified

January 1, 2013

Enrollment Period

11 months

First QC Date

January 4, 2013

Last Update Submit

January 9, 2013

Conditions

Knee Osteoarthritis

Keywords

knee osteoarthritistherapeutic effectinsole

Outcome Measures

Primary Outcomes (1)

  • pain

    Visual analog scale, pain pressure threshold

    change from baseline at one month and three months after modified shoe insoles wearing

Secondary Outcomes (6)

  • Physical functional ability

    change from baseline at one month and three months after modified shoe insoles wearing

  • psychological function

    change from baseline at one month and three months after modified shoe insoles wearing

  • functional performance

    change from baseline at one month and three months after modified shoe insoles wearing

  • quality of life

    change from baseline at one month and three months after modified shoe insoles wearing

  • balance performance

    change from baseline at one month and three months after modified shoe insoles wearing

  • +1 more secondary outcomes

Study Arms (2)

customized insoles

EXPERIMENTAL

customized full-length lateral wedged shoe insoles 1 month and 3 months study the immediate, short-term and intermediate-term therapeutic effects

Other: customized insoles

ready made insoles

PLACEBO COMPARATOR

ready-made full-length lateral wedged shoe insoles at 1 and 3 months study the immediate, short-term and intermediate-term therapeutic effects

Other: ready made insoles

Interventions

customized insolesOTHER

To study the immediate, short-term and intermediate-term therapeutic effects, including psychological function, physical activity , functional performance and quality of life, physical functional ability, pain and balance performance

Also known as: customized full-length lateral wedged insoles: ICB
customized insoles
ready made insolesOTHER

To study the immediate, short-term and intermediate-term therapeutic effects, including psychological function, physical activity , functional performance and quality of life, physical functional ability, pain and balance performance

Also known as: ready made full-length lateral wedged insoles: La New
ready made insoles

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • fulfill the combined clinical and radiographic criteria for knee osteoarthritis, as established by the American College of Rheumatology
  • with Kellgren-Lawrence scores of 2 or higher in the isolated medial compartment

You may not qualify if:

  • with a history of previous knee surgery with an implant
  • reduced lateral compartment and/or combined medial and lateral compartments in knee joints were excluded
  • pregnant or planning to become pregnant
  • self-reported history of vertigo, malignancy, stroke, or other conditions that may impair vestibular function

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shin Kong Wu Ho-Su Memorial Hospital

Taipei, Taiwan, 111-01, Taiwan

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Ru-Lan Hsieh, MD

    Shin Kong Wu Ho-Su Memorial Hospital; Taipei Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ru-Lan Hsieh, MD

CONTACT

886-2-28332211M001052@ms.skh.org.tw

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Associate professor

Study Record Dates

First Submitted

January 4, 2013

First Posted

January 10, 2013

Study Start

January 1, 2013

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

January 11, 2013

Record last verified: 2013-01

Locations

TW(1)