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Lateral Wedge Insole With Subtalar Strapping for Knee Osteoarthritis

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ClinicalTrials.gov Identifier: NCT01739296
Recruitment Status : Completed
First Posted : December 3, 2012
Last Update Posted : September 11, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This is a clinical study to evaluate the efficacy of a lateral wedge insole with subtalar strapping in knee osteoarthritis treatment.

Condition or disease Intervention/treatment
Osteoarthritis Other: Neutral insole with subtalar strapping (sham) Other: Lateral wedge insole with subtalar strapping

Detailed Description:
The objective of this study is to evaluate the efficacy of a lateral wedge insole with subtalar strapping in knee osteoarthritis treatment. Fifty-eight patients with knee osteoarthritis were randomized to use either a lateral wedge or a neutral insole. VAS, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and Lequesne questionnaires were applied at baseline, and weeks two, eight, and 24.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Lateral Wedge Insole With Subtalar Strapping for Knee Osteoarthritis: a Randomized Clinical Trial
Study Start Date : June 2011
Primary Completion Date : February 2012
Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Wedge
Lateral wedge insole with subtalar strapping Use of lateral wedge insoles with subtalar strapping for 5 to 10 hours daily
Other: Lateral wedge insole with subtalar strapping
Lateral wedge insole with subtalar strapping
Other Name: Wedge
Sham Comparator: Neutral
Neutral insole with subtalar strapping (sham) Use of neutral insoles with subtalar strapping for 5 to 10 hours daily
Other: Neutral insole with subtalar strapping (sham)
Neutral insole with subtalar strapping (sham)
Other Name: Neutral


Outcome Measures

Primary Outcome Measures :
  1. Symptoms [ Time Frame: 24 weeks ]
    Evaluation of patient's symptoms using WOMAC (western ontario and mcmaster universities osteoarthritis index), VAS (visual analogic scale of pain) and Lequesne questionaires


Secondary Outcome Measures :
  1. Ankle pain [ Time Frame: 24 weeks ]
    Number of patients that reported ankle pain related to the use of the insole as a measure of tolerability


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Meet the American College of Rheumatology criteria for knee Osteoarthritis
  • Varus malalignment of the knee
  • Absence of previous fracture on the index knee
  • Absence of previous surgery on the index knee
  • Absence of Rheumatoid Arthritis
  • No Intra-articular injection on the index knee in the past 6 months
  • Receiving usual care for Osteoarthritis for at least 6 months
  • Be able to understand and agree with the informed consent

Exclusion Criteria:

  • Undergo surgery during the study
  • Undergo Intra-articular injection during the study
  • Develop articular infection of the index joint during the study
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01739296


Locations
Brazil
Instituto de Ortopedia e Traumatologia HC-FMUSP
São Paulo, SP, Brazil, 05410-000
Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
Principal Investigator: Gustavo C Campos, MD FMUSP
More Information

Additional Information:
Responsible Party: University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT01739296     History of Changes
Other Study ID Numbers: 839/2011
First Posted: December 3, 2012    Key Record Dates
Last Update Posted: September 11, 2013
Last Verified: September 2013

Keywords provided by University of Sao Paulo General Hospital:
osteoarthritis
osteoarthritis, knee
foot orthoses
orthotic insoles

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases