Strengthening Program for Foot-ankle Muscles in People With Knee Osteoarthritis

Universidade Federal de Sao Carlos30 enrolled

Overview

The main objective of this trial is To evaluate the effect of an ankle and foot muscle strengthening program on pain, analgesic consumption, functionality, and lower limb biomechanics during gait in individuals with knee osteoarthritis.

A randomized controlled trial will be performed with 76 patients with knee osteoarthritis. The participants will be randomly assigned into either a control group (no exercises; they will keep their recommended clinical treatment) or an intervention group which will receive 8-week physical therapy exercises, three times per week, under the supervision of a physiotherapist. Every exercise has its own progression depending on the subjects' execution, increasing in intensity and difficulty. The subjects will be evaluated in 3 different moments (Baseline, immediately after treatment and 8 weeks follow-up). The hypothesis of this study is that the intervention group will decrease pain and medication intake, and improve functional performance, increase isometric strength of the feet and production of beneficial biomechanical changes during walking compared to the control group.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Knee Osteoarthritis

Interventions

Intervention GroupOTHER

Patients will receive a physical therapy intervention for strengthening, stretching and functional training of ankle and foot.

Eligibility

Sex: ALLMin age: 40 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Knee osteoarthritis (KOA) based on clinical and radiological criteria of American College of Reumathology; * KOA (Grade II and III - Radiological classification of Kellgreen and Laurence) in medial compartment of knee; * Knee pain between 30 and 80 on the visual analogue scale; * BMI \< 35 kg/m2. Exclusion Criteria: * KOA isolated (Grade II and III - Radiological classification of Kellgreen and Laurence) in lateral compartment of knee; * Lower limb strength training (3 times per week); * Wear minimalist shoes for at least 6 hours a day and 5 days a week; * Physical therapy in the previous 3 months; * Having received steroid injections and hyaluronic acid intra-articular knee in previous periods of three and six months respectively; * Previous history of surgery on knees, ankles and hips in the last 2 years; * Neurological disease; * Inflammatory arthritis (eg. rheumatoid arthritis); * Asymptomatic OA of one or both knees.

Locations (1)

Glauko Dantas

São Carlos, São Paulo, Brazil

Outcomes

Primary Outcomes

Change from baseline The WOMAC (Western Ontario and McMaster Universities) Pain Subscale at 8 and 16 weeks.

The WOMAC 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: Baseline, 8 weeks and 16 weeks.

Secondary Outcomes

Change from baseline WOMAC (Western Ontario and McMaster Universities) Stiffness Subscale at 8 and 16 weeks.

The stiffness subscale included in the WOMAC 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: Baseline, 8 weeks and 16 weeks.

Change from baseline WOMAC (Western Ontario and McMaster Universities) Physical Function Subscale at 8 and 16 weeks.

he physical function subscale included in the WOMAC 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: Baseline, 8 weeks and 16 weeks.

Change from baseline WOMAC (Western Ontario and McMaster Universities) Total Score at 8 and 16 weeks

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.

Data from ClinicalTrials.gov

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