NCT01342458

Brief Summary

The purpose of this study is to determine whether inexpensive, flexible and non-heeled footwear is effective in improving of clinical, functional and gait biomechanics in elderly women with knee osteoarthritis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P50-P75 for phase_1 knee-osteoarthritis

Timeline
Completed

Started Mar 2011

Typical duration for phase_1 knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
completed

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

March 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 20, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 27, 2011

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

January 12, 2015

Completed
Last Updated

January 26, 2015

Status Verified

January 1, 2015

Enrollment Period

2.3 years

First QC Date

April 20, 2011

Results QC Date

November 6, 2014

Last Update Submit

January 11, 2015

Conditions

Knee Osteoarthritis

Keywords

Knee osteoarthritisShoesGaitBiomechanics

Outcome Measures

Primary Outcomes (1)

  • Western Ontario and McMaster Universities (WOMAC) Pain Subscale

    The WOMAC (Western Ontario and McMaster Universities) pain subscale consists of five questions (Likert Scale) relating to the patient's pain in everyday situations. The Likert Scale version used for all WOMAC items are: none, mild, moderate, severe, and extreme. The sum of all items of pain subscale ranges from 0 to 20. Higher scores indicate worse pain.

    6 month

Secondary Outcomes (7)

  • WOMAC Stiffness Subscale

    6 month

  • WOMAC Physical Function Subscale

    6 month

  • WOMAC Total Score

    6 month

  • Global Score of the Lequesne´s Questionaire Algo-functional.

    6 month

  • Six-minute Walk Test

    6 month

  • +2 more secondary outcomes

Study Arms (2)

Intervention Group

EXPERIMENTAL

Daily use of the intervention Flexible footwear (Moleca®) for 6 months, for at least 42 hours/week (approximately 6 hours/day, 7 days/week). The Moleca® shoe (Calçados Beira Rio S.A., Novo Hamburgo, Rio Grande do Sul, Brazil) is a low-cost women's double canvas, flexible, flat, walking shoe without heels, with a 5-mm anti-slip rubber sole and a 3-mm flat insole of ethylene vinyl acetate that provides only protection but no correction. The mean weight of the shoe is 0.172±0.019 kg (range 0.091 to 0.182 kg), depending on size. This minimalist footwear is commonly worn by the elderly of all social classes and its average cost is US$ 6.25.

Other: Flexible footwear

Control Group

NO INTERVENTION

During the intervention period, patients from the Control Group (CG) were instructed not to wear Flexible footwear (Moleca®) or other similar minimalist footwear. During everyday activities, the CG group was only permitted to wear a standard, neutral tennis shoe. At the end of the intervention period, all CG participants also received one pair of Moleca® shoes at no cost.

Interventions

Flexible footwearOTHER

The patients of the Intervention Group (IG) will be use over 6 month a flexible and non-heeled footwear (Moleca; Calçados Beira Rio S.A., Novo Hamburgo, Rio Grande do Sul, Brazil) is a women's flexible flat walking shoe, without heels, with an anti-slip rubber sole, 5-mm thin, with a 3 mm internal wedge of ethylene vinyl acetate, made out of dubbed canvas. It had a mean weight of 172 ± 19.6 g, ranging from 142 to 193 g depending upon the size.

Intervention Group

Eligibility Criteria

Age60 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Kellgren and Lawrence grade 2 or 3
  • Being able to walk independently for at least 6 hours per day without the aid of canes or attendant to perform their activities of daily living
  • Knee pain between 3 and 8 on the visual analogue scale

You may not qualify if:

  • Previous history of surgery on knees, ankles and hips in the last 2 years
  • Neurological disease
  • BMI \> 35 kg/m2
  • Difference in lower limb length \> 1 cm
  • Prostheses and / or lower limb orthoses
  • Having received steroid injections and hyaluronic acid intra-articular knee in previous periods of three and six months respectively
  • Present at the knee joint instability (positive test results in the medial collateral ligament, lateral, anterior and posterior drawer)
  • OA of the hip and / or ankle incapacitating or diagnosed OA in lower limbs and spine
  • Inflammatory arthritis (eg. rheumatoid arthritis)
  • Asymptomatic OA of one or both knees
  • Dementia or inability to provide consistent information
  • Being under physiotherapy or acupuncture treatment
  • Patients with an indication of prosthesis or orthosis
  • Patients who are already using a flexible and non-heeled shoes for more than 25 hours per week (3 ½ hours per day) over the past 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Sao Paulo General Hospital

São Paulo, São Paulo, Brazil

Location

Related Publications (3)

  • Trombini-Souza F, Fuller R, Goldenstein-Schainberg C, Sacco ICN. Long-term use of minimal footwear in older adult women with knee osteoarthritis: Mechanisms of action in the knee adduction moment. J Biomech. 2020 Jul 17;108:109885. doi: 10.1016/j.jbiomech.2020.109885. Epub 2020 Jun 13.

    PMID: 32635999DERIVED

  • Trombini-Souza F, Matias AB, Yokota M, Butugan MK, Goldenstein-Schainberg C, Fuller R, Sacco IC. Long-term use of minimal footwear on pain, self-reported function, analgesic intake, and joint loading in elderly women with knee osteoarthritis: A randomized controlled trial. Clin Biomech (Bristol). 2015 Dec;30(10):1194-201. doi: 10.1016/j.clinbiomech.2015.08.004. Epub 2015 Aug 14.

    PMID: 26307181DERIVED

  • Trombini-Souza F, Fuller R, Matias A, Yokota M, Butugan M, Goldenstein-Schainberg C, Sacco IC. Effectiveness of a long-term use of a minimalist footwear versus habitual shoe on pain, function and mechanical loads in knee osteoarthritis: a randomized controlled trial. BMC Musculoskelet Disord. 2012 Jul 12;13:121. doi: 10.1186/1471-2474-13-121.

    PMID: 22788574DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Results Point of Contact

Title
Dr. Francis Trombini-Souza
Organization
University of Sao Paulo
trombinisouza@usp.br
55 11 3091 8426

Study Officials

  • Isabel CN Sacco, PhD

    Department of Physical therapy, Speech, and Occupational Therapy, School of Medicine, University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

April 20, 2011

First Posted

April 27, 2011

Study Start

March 1, 2011

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

January 26, 2015

Results First Posted

January 12, 2015

Record last verified: 2015-01

Locations

BR(1)