Trial Outcomes & Findings for Effect of Footwear on the Clinical, Functional, and Biomechanical Aspects in Elderly Women With Knee Osteoarthritis (OA) (NCT NCT01342458)
NCT ID: NCT01342458
Last Updated: 2015-01-26
Results Overview
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.
COMPLETED
PHASE1
56 participants
6 month
2015-01-26
Participant Flow
The participants were recruited from the primary care centre of the School of Medicine, University of São Paulo Hospital, and rheumatology ambulatory medical. Participants were recruited between March 2011 and December 2012, and allocated equally into one of two groups.
Participant milestones
| Measure |
Intervention Group
Daily use of the intervention 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.
|
Control Group
During the intervention period, patients from the Control Group (CG) were instructed not to wear 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.
|
|---|---|---|
|
Overall Study
STARTED
|
28
|
28
|
|
Overall Study
COMPLETED
|
26
|
24
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Footwear on the Clinical, Functional, and Biomechanical Aspects in Elderly Women With Knee Osteoarthritis (OA)
Baseline characteristics by cohort
| Measure |
Intervention Group
n=28 Participants
Daily use of the intervention 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.
|
Control Group
n=28 Participants
During the intervention period, patients from the Control Group (CG) were instructed not to wear 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.
|
Total
n=56 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
21 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Age, Continuous
|
66 years
STANDARD_DEVIATION 5 • n=99 Participants
|
66 years
STANDARD_DEVIATION 6 • n=107 Participants
|
66 years
STANDARD_DEVIATION 5 • n=206 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
56 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
Brazil
|
28 participants
n=99 Participants
|
28 participants
n=107 Participants
|
56 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 6 monthPopulation: An intention-to-treat analysis was performed, and the missing data were treated as missing completely at random (MCAR) using the Mahalanobis imputation method (SOLAS software version 4.0; Statistical Solutions Ltd., Cork, Ireland).
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.
Outcome measures
| Measure |
Intervention Group
n=26 Participants
WOMAC pain subscale
|
Control Group
n=24 Participants
WOMAC pain subscale
|
|---|---|---|
|
Western Ontario and McMaster Universities (WOMAC) Pain Subscale
WOMAC pain (Baseline)
|
9.2 score
Standard Deviation 4.0
|
10.0 score
Standard Deviation 3.9
|
|
Western Ontario and McMaster Universities (WOMAC) Pain Subscale
WOMAC pain (3rd month)
|
4.5 score
Standard Deviation 2.3
|
6.6 score
Standard Deviation 4.7
|
|
Western Ontario and McMaster Universities (WOMAC) Pain Subscale
WOMAC pain (6th month)
|
3.1 score
Standard Deviation 2.2
|
7.2 score
Standard Deviation 4.8
|
SECONDARY outcome
Timeframe: 6 monthThe 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.
Outcome measures
| Measure |
Intervention Group
n=26 Participants
WOMAC pain subscale
|
Control Group
n=24 Participants
WOMAC pain subscale
|
|---|---|---|
|
WOMAC Stiffness Subscale
WOMAC Stiffness subscale (Baseline)
|
1.8 score
Standard Deviation 1.9
|
2.4 score
Standard Deviation 2.3
|
|
WOMAC Stiffness Subscale
WOMAC Stiffness subscale (3rd month)
|
0.8 score
Standard Deviation 0.9
|
2.9 score
Standard Deviation 2.1
|
|
WOMAC Stiffness Subscale
WOMAC Stiffness subscale (6th month)
|
0.7 score
Standard Deviation 1.1
|
2.0 score
Standard Deviation 2.4
|
SECONDARY outcome
Timeframe: 6 monthThe 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.
Outcome measures
| Measure |
Intervention Group
n=26 Participants
WOMAC pain subscale
|
Control Group
n=24 Participants
WOMAC pain subscale
|
|---|---|---|
|
WOMAC Physical Function Subscale
WOMAC Physical function subscale (Baseline)
|
27.6 score
Standard Deviation 14.3
|
29.6 score
Standard Deviation 13.2
|
|
WOMAC Physical Function Subscale
WOMAC Physical function subscale (3rd month)
|
13.2 score
Standard Deviation 7.3
|
20.9 score
Standard Deviation 12.8
|
|
WOMAC Physical Function Subscale
WOMAC Physical function subscale (6 month)
|
10.2 score
Standard Deviation 6.5
|
23.9 score
Standard Deviation 14.8
|
SECONDARY outcome
Timeframe: 6 monthThe 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.
Outcome measures
| Measure |
Intervention Group
n=26 Participants
WOMAC pain subscale
|
Control Group
n=24 Participants
WOMAC pain subscale
|
|---|---|---|
|
WOMAC Total Score
WOMAC total score (Baseline)
|
37.7 score
Standard Deviation 17.9
|
42.0 score
Standard Deviation 17.3
|
|
WOMAC Total Score
WOMAC total score (3rd month)
|
17.6 score
Standard Deviation 8.9
|
30.4 score
Standard Deviation 18.3
|
|
WOMAC Total Score
WOMAC total score (6th month)
|
14.3 score
Standard Deviation 8.8
|
33.8 score
Standard Deviation 20.3
|
SECONDARY outcome
Timeframe: 6 monthThis 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.
Outcome measures
| Measure |
Intervention Group
n=26 Participants
WOMAC pain subscale
|
Control Group
n=24 Participants
WOMAC pain subscale
|
|---|---|---|
|
Global Score of the Lequesne´s Questionaire Algo-functional.
Lequesne (Baseline)
|
9.7 score
Standard Deviation 3.5
|
11.5 score
Standard Deviation 3.3
|
|
Global Score of the Lequesne´s Questionaire Algo-functional.
Lequesne (3rd month)
|
6.3 score
Standard Deviation 3.1
|
8.9 score
Standard Deviation 4.3
|
|
Global Score of the Lequesne´s Questionaire Algo-functional.
Lequesne (6th month)
|
5.5 score
Standard Deviation 3.2
|
9.7 score
Standard Deviation 4.7
|
SECONDARY outcome
Timeframe: 6 monthThe six-minute walk test assesses distance in meters walked over 6 minutes.
Outcome measures
| Measure |
Intervention Group
n=26 Participants
WOMAC pain subscale
|
Control Group
n=24 Participants
WOMAC pain subscale
|
|---|---|---|
|
Six-minute Walk Test
Six-minute walk test (Baseline)
|
433.5 meter
Standard Deviation 48.9
|
430.6 meter
Standard Deviation 56.8
|
|
Six-minute Walk Test
Six-minute walk test (3rd month)
|
453.5 meter
Standard Deviation 40.6
|
431.6 meter
Standard Deviation 43.1
|
|
Six-minute Walk Test
Six-minute walk test (6th month)
|
439.3 meter
Standard Deviation 34.7
|
428.3 meter
Standard Deviation 44.2
|
SECONDARY outcome
Timeframe: 6 monthThe 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.
Outcome measures
| Measure |
Intervention Group
n=26 Participants
WOMAC pain subscale
|
Control Group
n=24 Participants
WOMAC pain subscale
|
|---|---|---|
|
First Peak of the Knee Adduction Moment (KAM) During Gait.
KAM (Baseline)
|
2.44 % body weight x height in centimeters
Standard Deviation 0.77
|
2.21 % body weight x height in centimeters
Standard Deviation 1.06
|
|
First Peak of the Knee Adduction Moment (KAM) During Gait.
KAM (6th month)
|
2.37 % body weight x height in centimeters
Standard Deviation 0.63
|
2.28 % body weight x height in centimeters
Standard Deviation 1.12
|
SECONDARY outcome
Timeframe: 6 monthParacetamol intake (500 mg), number of tablets per month.
Outcome measures
| Measure |
Intervention Group
n=26 Participants
WOMAC pain subscale
|
Control Group
n=24 Participants
WOMAC pain subscale
|
|---|---|---|
|
Paracetamol Intake
|
0 tablets per month
Interval 0.0 to 3.0
|
10 tablets per month
Interval 6.0 to 24.0
|
Adverse Events
Intervention Group
Control Group
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Intervention Group
n=28 participants at risk
Daily use of the intervention 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.
|
Control Group
n=28 participants at risk
During the intervention period, patients from the Control Group (CG) were instructed not to wear 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.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Keratosis on metatarsal head
|
3.6%
1/28
|
0.00%
0/28
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place