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Effect of Footwear on the Clinical, Functional, and Biomechanical Aspects in Elderly Women With Knee Osteoarthritis (OA) (OA)

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Phase 1
Locations
Brazil
Study Type
Interventional
Intervention
Flexible footwear
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Knee osteoarthritis, Shoes, Gait, Biomechanics

Eligibility Criteria

60 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Introduction of Nonsteroidal Anti-inflammatory Drugs and analgesic medications 8 weeks before inclusion or change of dosage of the same after the inclusion
  • 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

Sites / Locations

  • University of Sao Paulo General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Group

Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

WOMAC Stiffness Subscale
The stiffness subscale included in the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) index consists of two questions (Likert Scale) relating articular function of the patient. The Likert Scale version used for all WOMAC items are: none, mild, moderate, severe, and extreme. The sum of all items of the stiffness subscale ranges from 0 to 8. Higher scores on the stiffness WOMAC subscale indicate worse articular function.
WOMAC Physical Function Subscale
The physical function subscale included in the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) index consists of seventeen questions (Likert Scale) relating to the patient's physical activities, or skills to move out and take care of themselves. The Likert Scale version used for all WOMAC items are: none, mild, moderate, severe, and extreme. The sum of all items of physical function subscale ranges from 0 to 68. Higher scores on the physical function WOMAC subscale indicate worse functional limitations.
WOMAC Total Score
The WOMAC total score is the sum of all subscale (pain, function and stiffness) (Likert Scale) relating to the patient's physical activities, or skills to move out and take care of themselves. The Likert Scale version used for all WOMAC items are: none, mild, moderate, severe, and extreme. The sum of all items ranges from 0 to 96. Higher scores on the WOMAC total score indicate worse condition.
Global Score of the Lequesne´s Questionaire Algo-functional.
This questionaire consists of three sections (eleven questions): about pain or discomfort, the maximum distance that the patient can walk, and activities of daily living. Scores range from zero to twenty-four, meaning cases without involvement and with extremely severe impairment, respectively.
Six-minute Walk Test
The six-minute walk test assesses distance in meters walked over 6 minutes.
First Peak of the Knee Adduction Moment (KAM) During Gait.
The first peak of the external knee moment was calculated by mean inverse dynamics approach. To this procedure, we used the kinematics data of the lower limbs assessed with six infrared cameras and the ground reaction force evaluated by mean a force platform. This is a continuous measure.
Paracetamol Intake
Paracetamol intake (500 mg), number of tablets per month.

Full Information

First Posted
April 20, 2011
Last Updated
January 11, 2015
Sponsor
University of Sao Paulo General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01342458
Brief Title
Effect of Footwear on the Clinical, Functional, and Biomechanical Aspects in Elderly Women With Knee Osteoarthritis (OA)
Acronym
OA
Official Title
Therapeutic Effect of Inexpensive, Flexible and Non-heeled Footwear on the Clinical, Functional and Gait Biomechanics in Elderly Women With Knee Osteoarthritis: a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo General Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The clinical and functional aspects will be evaluated using a visual analogue scale (VAS) for pain, Western Ontario and McMaster Universities (WOMAC) and Lequesne questionnaires of quality of life in patients with knee osteoarthritis and testing of six-minute walk (6MWT). Biomechanical analysis of gait will be performed by infrared cameras and a force platform. From the data of kinematics and kinetics, will be calculated moments of the knee joint strength by inverse dynamics. The process (steps) will be divided as follows: step 1, in this step there will be sorting and initial assessment of potential participants; pain will be evaluated through VAS, function and quality of life by means of questionnaires WOMAC and Lequesne and the 6MWT, and by evaluating the biomechanics of gait. step 2,(3 month follow-up), both groups will be evaluated again by the VAS and WOMAC and Lequesne questionnaires. step 3, after 6 months of starting the monitoring process, both groups will be reevaluated through the VAS, WOMAC, Lequesne, 6MWT and biomechanical analysis of gait. This step is the final evaluation, characterizing the end of intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Knee osteoarthritis, Shoes, Gait, Biomechanics

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Flexible footwear
Intervention Description
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.
Primary Outcome Measure Information:
Title
Western Ontario and McMaster Universities (WOMAC) Pain Subscale
Description
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.
Time Frame
6 month
Secondary Outcome Measure Information:
Title
WOMAC Stiffness Subscale
Description
The stiffness subscale included in the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) index consists of two questions (Likert Scale) relating articular function of the patient. The Likert Scale version used for all WOMAC items are: none, mild, moderate, severe, and extreme. The sum of all items of the stiffness subscale ranges from 0 to 8. Higher scores on the stiffness WOMAC subscale indicate worse articular function.
Time Frame
6 month
Title
WOMAC Physical Function Subscale
Description
The physical function subscale included in the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) index consists of seventeen questions (Likert Scale) relating to the patient's physical activities, or skills to move out and take care of themselves. The Likert Scale version used for all WOMAC items are: none, mild, moderate, severe, and extreme. The sum of all items of physical function subscale ranges from 0 to 68. Higher scores on the physical function WOMAC subscale indicate worse functional limitations.
Time Frame
6 month
Title
WOMAC Total Score
Description
The WOMAC total score is the sum of all subscale (pain, function and stiffness) (Likert Scale) relating to the patient's physical activities, or skills to move out and take care of themselves. The Likert Scale version used for all WOMAC items are: none, mild, moderate, severe, and extreme. The sum of all items ranges from 0 to 96. Higher scores on the WOMAC total score indicate worse condition.
Time Frame
6 month
Title
Global Score of the Lequesne´s Questionaire Algo-functional.
Description
This questionaire consists of three sections (eleven questions): about pain or discomfort, the maximum distance that the patient can walk, and activities of daily living. Scores range from zero to twenty-four, meaning cases without involvement and with extremely severe impairment, respectively.
Time Frame
6 month
Title
Six-minute Walk Test
Description
The six-minute walk test assesses distance in meters walked over 6 minutes.
Time Frame
6 month
Title
First Peak of the Knee Adduction Moment (KAM) During Gait.
Description
The first peak of the external knee moment was calculated by mean inverse dynamics approach. To this procedure, we used the kinematics data of the lower limbs assessed with six infrared cameras and the ground reaction force evaluated by mean a force platform. This is a continuous measure.
Time Frame
6 month
Title
Paracetamol Intake
Description
Paracetamol intake (500 mg), number of tablets per month.
Time Frame
6 month

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 Introduction of Nonsteroidal Anti-inflammatory Drugs and analgesic medications 8 weeks before inclusion or change of dosage of the same after the inclusion 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Isabel CN Sacco, PhD
Organizational Affiliation
Department of Physical therapy, Speech, and Occupational Therapy, School of Medicine, University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Sao Paulo General Hospital
City
Sao Paulo
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
32635999
Citation
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.
Results Reference
derived
PubMed Identifier
26307181
Citation
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, Avon). 2015 Dec;30(10):1194-201. doi: 10.1016/j.clinbiomech.2015.08.004. Epub 2015 Aug 14.
Results Reference
derived
PubMed Identifier
22788574
Citation
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.
Results Reference
derived

Learn more about this trial

Effect of Footwear on the Clinical, Functional, and Biomechanical Aspects in Elderly Women With Knee Osteoarthritis (OA)

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