Phase 1
N=56
Effect of Footwear on the Clinical, Functional, and Biomechanical Aspects in Elderly Women With Knee Osteoarthritis (OA)
Knee Osteoarthritis
Bottom Line
View on ClinicalTrials.gov: NCT01342458 ↗Enrolled (actual)
56
Serious AEs
0.0%
Results posted
Jan 2015
Primary outcome: Primary: Western Ontario and McMaster Universities (WOMAC) Pain Subscale — 9.2; 10.0; 4.5; 6.6 score — p=0.006
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Flexible footwear (Other)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- Female
- Sponsor
- University of Sao Paulo General Hospital
- Primary completion
- Jun 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Western Ontario and McMaster Universities (WOMAC) Pain Subscale |
9.2; 10.0; 4.5; 6.6; 3.1; 7.2 | 0.006 sig |
| SECONDARY WOMAC Stiffness Subscale |
1.8; 2.4; 0.8; 2.9; 0.7; 2.0 | 0.015 sig |
| SECONDARY WOMAC Physical Function Subscale |
27.6; 29.6; 13.2; 20.9; 10.2; 23.9 | <0.001 sig |
| SECONDARY WOMAC Total Score |
37.7; 42.0; 17.6; 30.4; 14.3; 33.8 | <0.001 sig |
| SECONDARY Global Score of the Lequesne´s Questionaire Algo-functional. |
9.7; 11.5; 6.3; 8.9; 5.5; 9.7 | 0.019 sig |
| SECONDARY Six-minute Walk Test |
433.5; 430.6; 453.5; 431.6; 439.3; 428.3 | 0.425 |
| SECONDARY First Peak of the Knee Adduction Moment (KAM) During Gait. |
2.44; 2.21; 2.37; 2.28 | 0.443 |
| SECONDARY Paracetamol Intake |
0; 10 | <0.001 sig |
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.
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
Data sourced from ClinicalTrials.gov (NCT01342458). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.