Clinical trial NCT01342458: Effect of Footwear on the Clinical, Functional, and Biomechanical Aspects in Elderly Women With Knee Osteoarthritis (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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Knee Osteoarthritis
Keywords: Knee osteoarthritis
Shoes
Gait
Biomechanics
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2011-04-27
Enrollment: 56
Sex: FEMALE
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Western Ontario and McMaster Universities (WOMAC) Pain Subscale
timeFrame: 6 month
Secondary outcomes:
measure: WOMAC Stiffness Subscale
timeFrame: 6 month
measure: WOMAC Physical Function Subscale
timeFrame: 6 month
measure: WOMAC Total Score
timeFrame: 6 month
measure: Global Score of the Lequesne´s Questionaire Algo-functional.
timeFrame: 6 month
measure: Six-minute Walk Test
timeFrame: 6 month
measure: First Peak of the Knee Adduction Moment (KAM) During Gait.
timeFrame: 6 month
measure: Paracetamol Intake
timeFrame: 6 month
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: University of Sao Paulo General Hospital
Study officials:
affiliation: Department of Physical therapy, Speech, and Occupational Therapy, School of Medicine, University of Sao Paulo
name: Isabel CN Sacco, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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). 2015 Dec;30(10):1194-201. doi: 10.1016/j.clinbiomech.2015.08.004. Epub 2015 Aug 14.
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.