NCT01763515

Brief Summary

Knee osteoarthritis is a common problem with the disease prevalence increasing with advancing age. This study will be performed in the purpose of determination the effects of laterally wedged insoles on symptoms reduction of patients with knee osteoarthritis.

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
120

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2012

Shorter than P25 for phase_2

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

October 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 28, 2012

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 9, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

January 9, 2013

Status Verified

January 1, 2013

Enrollment Period

10 months

First QC Date

December 28, 2012

Last Update Submit

January 8, 2013

Conditions

Osteoarthritis, Knee

Keywords

Joint DiseasesArthritisOsteoarthritis

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in knee pain severity after 2 months.

    The pain score (100 mm Visual Analogue Score ) is evaluated at baseline and then after 2 months of therapy.

    Up to 2 months

Secondary Outcomes (1)

  • Change from baseline in knee's functional degree after 2 months.

    Up to 2 months.

Study Arms (1)

Laterally wedged insoles

EXPERIMENTAL

Patients will use laterally wedged insoles with 5o tilt toward medial side and made of ethylene vinyl acetate coated with leather. The medial thickness is 4 mm with lateral thickness of 10 mm.

Procedure: Laterally wedged insoles

Interventions

Laterally wedged insolesPROCEDURE

Patients will use laterally wedged insoles with 5o tilt toward medial side and made of ethylene vinyl acetate coated with leather. The medial thickness is 4 mm with lateral thickness of 10 mm.

Laterally wedged insoles

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Symptomatic medial femorotibial knee OA,
  • Daily knee pain for at least 1 month in the last 3 months,
  • Radiographic evidence of medial femorotibial knee OA,
  • Normal erythrocyte sedimentation rate.

You may not qualify if:

  • Secondary knee OA, hip OA, symptomatic foot deformities, articular space loss more or the same as lateral femorotibial side in radiography,
  • Knee joint lavage in past 3 months,
  • Intra-articular corticosteroid injection during the past 3 months,
  • Tibial osteotomy during last 5 years and changes in drug treatment for OA during last week.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Rehabilitation, Alzahra Hospital

Isfahan, Isfahan, Iran

Location

Related Publications (3)

  • Hinman RS, Bowles KA, Bennell KL. Laterally wedged insoles in knee osteoarthritis: do biomechanical effects decline after one month of wear? BMC Musculoskelet Disord. 2009 Nov 25;10:146. doi: 10.1186/1471-2474-10-146.

    PMID: 19939281BACKGROUND

  • Bennell K, Bowles KA, Payne C, Cicuttini F, Osborne R, Harris A, Hinman R. Effects of laterally wedged insoles on symptoms and disease progression in medial knee osteoarthritis: a protocol for a randomised, double-blind, placebo controlled trial. BMC Musculoskelet Disord. 2007 Sep 24;8:96. doi: 10.1186/1471-2474-8-96.

    PMID: 17892539BACKGROUND

  • Pham T, Maillefert JF, Hudry C, Kieffert P, Bourgeois P, Lechevalier D, Dougados M. Laterally elevated wedged insoles in the treatment of medial knee osteoarthritis. A two-year prospective randomized controlled study. Osteoarthritis Cartilage. 2004 Jan;12(1):46-55. doi: 10.1016/j.joca.2003.08.011.

    PMID: 14697682BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, KneeJoint DiseasesArthritisOsteoarthritis

Condition Hierarchy (Ancestors)

Musculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Farnaz Dehghan, MD

    Isfahan University of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

December 28, 2012

First Posted

January 9, 2013

Study Start

October 1, 2012

Primary Completion

August 1, 2013

Study Completion

October 1, 2013

Last Updated

January 9, 2013

Record last verified: 2013-01

Locations

IR(1)