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

Phase 1

Completed

Conditions: Knee Osteoarthritis

Interventions: Other: Flexible footwear

Registration Number: NCT01342458

Lead Sponsor: University of Sao Paulo General Hospital

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 56

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group	Flexible footwear	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.

Primary Outcome Measures

Name	Time	Method
Western Ontario and McMaster Universities (WOMAC) Pain Subscale	6 month	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

Name	Time	Method
WOMAC Total Score	6 month	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.
Paracetamol Intake	6 month	Paracetamol intake (500 mg), number of tablets per month.
WOMAC Stiffness Subscale	6 month	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.
First Peak of the Knee Adduction Moment (KAM) During Gait.	6 month	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.
WOMAC Physical Function Subscale	6 month	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.
Global Score of the Lequesne´s Questionaire Algo-functional.	6 month	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	6 month	The six-minute walk test assesses distance in meters walked over 6 minutes.