Trial Outcomes & Findings for An Intervention of Electrical Stimulation in Osteoarthritis (NCT NCT00500448)
NCT ID: NCT00500448
Last Updated: 2016-08-29
Results Overview
Knee extension Torque recorded during voluntary contraction/Knee extension torque recorded during contraction with superimposed stimulus
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
Baseline and 12 weeks post-intervention
Results posted on
2016-08-29
Participant Flow
Participant milestones
| Measure |
No Treatment
No treatment was delivered to this arm. Participants went about activities of daily living
|
Neuromuscular Electrical Stimulation
Neuromuscular electrical stimulation treatments 3 times per week for 4 weeks
Neuromuscular Electrical Stimulation (Vectra Genisys 4 Channel Electrotherapy System): Estim will be delivered 3 times per week for 4 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
16
|
|
Overall Study
COMPLETED
|
14
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
An Intervention of Electrical Stimulation in Osteoarthritis
Baseline characteristics by cohort
| Measure |
No Treatment
n=14 Participants
No treatment was delivered to this arm. Participants went about activities of daily living
|
Neuromuscular Electrical Stimulation
n=16 Participants
Neuromuscular electrical stimulation treatments 3 times per week for 4 weeks
Neuromuscular Electrical Stimulation (Vectra Genisys 4 Channel Electrotherapy System): Estim will be delivered 3 times per week for 4 weeks
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.8 Years
STANDARD_DEVIATION 2.9 • n=5 Participants
|
58 Years
STANDARD_DEVIATION 2.7 • n=7 Participants
|
57.4 Years
STANDARD_DEVIATION 2.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
16 participants
n=7 Participants
|
30 participants
n=5 Participants
|
|
Height
|
163.3 cm
STANDARD_DEVIATION 4.5 • n=5 Participants
|
162.3 cm
STANDARD_DEVIATION 7.4 • n=7 Participants
|
162.8 cm
STANDARD_DEVIATION 5.95 • n=5 Participants
|
|
Mass
|
87.8 kg
STANDARD_DEVIATION 12.5 • n=5 Participants
|
86.3 kg
STANDARD_DEVIATION 13.6 • n=7 Participants
|
87.05 kg
STANDARD_DEVIATION 13.05 • n=5 Participants
|
|
BMI
|
32.1 kg^m2
STANDARD_DEVIATION 5.1 • n=5 Participants
|
32.7 kg^m2
STANDARD_DEVIATION 4.1 • n=7 Participants
|
32.4 kg^m2
STANDARD_DEVIATION 4.6 • n=5 Participants
|
|
Quadriceps Strength
|
1.24 Nm/kg
STANDARD_DEVIATION 0.35 • n=5 Participants
|
1.29 Nm/kg
STANDARD_DEVIATION 0.46 • n=7 Participants
|
1.26 Nm/kg
STANDARD_DEVIATION 0.41 • n=5 Participants
|
|
Central Activation Ratio (CAR)
|
.83 ratio
STANDARD_DEVIATION .15 • n=5 Participants
|
.90 ratio
STANDARD_DEVIATION .08 • n=7 Participants
|
.86 ratio
STANDARD_DEVIATION .12 • n=5 Participants
|
|
WOMAC Pain Score
|
8.9 units on a scale (range 5-25)
STANDARD_DEVIATION 4.3 • n=5 Participants
|
7.6 units on a scale (range 5-25)
STANDARD_DEVIATION 2.7 • n=7 Participants
|
8.25 units on a scale (range 5-25)
STANDARD_DEVIATION 3.5 • n=5 Participants
|
|
WOMAC disability scale
|
28.8 units on a scale (range 17-85)
STANDARD_DEVIATION 15.3 • n=5 Participants
|
27.1 units on a scale (range 17-85)
STANDARD_DEVIATION 12.1 • n=7 Participants
|
27.95 units on a scale (range 17-85)
STANDARD_DEVIATION 13.7 • n=5 Participants
|
|
Timed Walking speed
|
1.40 m/s
STANDARD_DEVIATION .13 • n=5 Participants
|
1.43 m/s
STANDARD_DEVIATION .19 • n=7 Participants
|
1.42 m/s
STANDARD_DEVIATION .16 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 12 weeks post-interventionKnee extension Torque recorded during voluntary contraction/Knee extension torque recorded during contraction with superimposed stimulus
Outcome measures
| Measure |
No Treatment
n=14 Participants
No treatment was delivered to this arm. Participants went about activities of daily living
|
Neuromuscular Electrical Stimulation
n=16 Participants
Neuromuscular electrical stimulation treatments 3 times per week for 4 weeks
Neuromuscular Electrical Stimulation (Vectra Genisys 4 Channel Electrotherapy System): Estim will be delivered 3 times per week for 4 weeks
|
|---|---|---|
|
Change From Baseline in Quadriceps Central Activation Ratio at 12 Weeks
|
0.01 unitless
Interval -0.09 to 0.1
|
-0.04 unitless
Interval -0.11 to 0.03
|
PRIMARY outcome
Timeframe: Baseline and 12 weeks following the interventionOutcome measures
| Measure |
No Treatment
n=14 Participants
No treatment was delivered to this arm. Participants went about activities of daily living
|
Neuromuscular Electrical Stimulation
n=16 Participants
Neuromuscular electrical stimulation treatments 3 times per week for 4 weeks
Neuromuscular Electrical Stimulation (Vectra Genisys 4 Channel Electrotherapy System): Estim will be delivered 3 times per week for 4 weeks
|
|---|---|---|
|
Change From Baseline in Quadriceps Strength at 12 Weeks
|
.14 Nm/kg
Interval -0.2 to 0.49
|
-0.21 Nm/kg
Interval -0.5 to 0.08
|
SECONDARY outcome
Timeframe: baseline and 12 weeks post-interventionWomac Disability Score is on a scale from 17 (no functional loss) to 85 (severe functional loss)
Outcome measures
| Measure |
No Treatment
n=14 Participants
No treatment was delivered to this arm. Participants went about activities of daily living
|
Neuromuscular Electrical Stimulation
n=15 Participants
Neuromuscular electrical stimulation treatments 3 times per week for 4 weeks
Neuromuscular Electrical Stimulation (Vectra Genisys 4 Channel Electrotherapy System): Estim will be delivered 3 times per week for 4 weeks
|
|---|---|---|
|
Change From Baseline in WOMAC Disability Score at 12 Weeks
|
5.0 units on a scale
Interval 0.59 to 9.41
|
-4.92 units on a scale
Interval -10.89 to 1.05
|
SECONDARY outcome
Timeframe: Baseline and 12 weeks post-interventionOutcome measures
| Measure |
No Treatment
n=14 Participants
No treatment was delivered to this arm. Participants went about activities of daily living
|
Neuromuscular Electrical Stimulation
n=16 Participants
Neuromuscular electrical stimulation treatments 3 times per week for 4 weeks
Neuromuscular Electrical Stimulation (Vectra Genisys 4 Channel Electrotherapy System): Estim will be delivered 3 times per week for 4 weeks
|
|---|---|---|
|
Change From Baseline in Timed Walking Speed at 12 Weeks
|
0.04 m/s
Interval -0.09 to 0.17
|
-0.05 m/s
Interval -0.13 to 0.03
|
SECONDARY outcome
Timeframe: Baseline and 12 weeks following interventionWOMAC Pain Score ranges from 5 (no pain) to 25 (worst possible pain)
Outcome measures
| Measure |
No Treatment
n=14 Participants
No treatment was delivered to this arm. Participants went about activities of daily living
|
Neuromuscular Electrical Stimulation
n=16 Participants
Neuromuscular electrical stimulation treatments 3 times per week for 4 weeks
Neuromuscular Electrical Stimulation (Vectra Genisys 4 Channel Electrotherapy System): Estim will be delivered 3 times per week for 4 weeks
|
|---|---|---|
|
Change From Baseline in WOMAC Pain Score at 12 Weeks
|
1.4 units on a scale
Interval -0.26 to 3.06
|
-0.54 units on a scale
Interval -1.83 to 0.75
|
Adverse Events
No Treatment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Neuromuscular Electrical Stimulation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place