Trial Outcomes & Findings for E-Stim and Achilles Tendon Repair Study (NCT NCT01833936)
NCT ID: NCT01833936
Last Updated: 2018-01-10
Results Overview
Magnetic resonance imaging (MRI) scans were conducted preoperatively and postoperatively at weeks 2 and 6 to measure cross sectional muscle volumes of the calf muscle. By measuring the muscle volume, the investigators hope to show the use of electrical stimulation will reduce calf muscle atrophy.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
Pre-operative, 2 weeks, and 6 weeks post-operative
Results posted on
2018-01-10
Participant Flow
Participant milestones
| Measure |
Group 1- Compex® Muscle Stimulator
Group 1 will receive an active muscle stimulator, which will be placed immediately following surgery. Eight electrodes will be placed on the lower leg: four electrodes on the gastrocnemius (calf muscle), and two electrodes each on the lateral gastrocnemius (side) and anterior tibialis muscle (front). Subjects will use the stimulator for three 20 minute sessions per day.
Compex® muscle stimulator: The Compex® muscle stimulator is a commercially available muscle stimulator that is approved by the Food and Drug Administration (FDA), a governmental body. It is not investigational. The investigational part of this study aims to evaluate if the use of muscle simulation after Achilles tendon surgery will reduce calf atrophy.
|
Group 2 -(Inactive) Muscle Stimulator
Group 2 will receive a placebo (inactive) muscle stimulator, which will be placed immediately following surgery. Eight electrodes will be placed on the lower leg: four electrodes on the gastrocnemius (calf muscle), and two electrodes each on the lateral gastrocnemius (side) and anterior tibialis muscle (front). Subjects will be instructed to use the stimulator for three 20 minute sessions per day.
(inactive) muscle stimulator: A placebo (inactive) muscle stimulator, which will be placed immediately following surgery. Eight electrodes will be placed on the lower leg: four electrodes on the gastrocnemius (calf muscle), and two electrodes each on the lateral gastrocnemius (side) and anterior tibialis muscle (front). Subjects will be instructed to use the stimulator for three 20 minute sessions per day.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
16
|
18
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
E-Stim and Achilles Tendon Repair Study
Baseline characteristics by cohort
| Measure |
Group 1- Compex® Muscle Stimulator
n=20 Participants
Group 1 will receive an active muscle stimulator, which will be placed immediately following surgery. Eight electrodes will be placed on the lower leg: four electrodes on the gastrocnemius (calf muscle), and two electrodes each on the lateral gastrocnemius (side) and anterior tibialis muscle (front). Subjects will use the stimulator for three 20 minute sessions per day.
Compex® muscle stimulator: The Compex® muscle stimulator is a commercially available muscle stimulator that is approved by the Food and Drug Administration (FDA), a governmental body. It is not investigational. The investigational part of this study aims to evaluate if the use of muscle simulation after Achilles tendon surgery will reduce calf atrophy.
|
Group 2 -(Inactive) Muscle Stimulator
n=20 Participants
Group 2 will receive a placebo (inactive) muscle stimulator, which will be placed immediately following surgery. Eight electrodes will be placed on the lower leg: four electrodes on the gastrocnemius (calf muscle), and two electrodes each on the lateral gastrocnemius (side) and anterior tibialis muscle (front). Subjects will be instructed to use the stimulator for three 20 minute sessions per day.
(inactive) muscle stimulator: A placebo (inactive) muscle stimulator, which will be placed immediately following surgery. Eight electrodes will be placed on the lower leg: four electrodes on the gastrocnemius (calf muscle), and two electrodes each on the lateral gastrocnemius (side) and anterior tibialis muscle (front). Subjects will be instructed to use the stimulator for three 20 minute sessions per day.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.0 years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
45.8 years
STANDARD_DEVIATION 11.8 • n=7 Participants
|
48.9 years
STANDARD_DEVIATION 11.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Body Mass Index
|
33.4 kg/m^2
STANDARD_DEVIATION 5.6 • n=5 Participants
|
31.1 kg/m^2
STANDARD_DEVIATION 5.6 • n=7 Participants
|
32.2 kg/m^2
STANDARD_DEVIATION 5.7 • n=5 Participants
|
|
Tobacco Use
Current
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Tobacco Use
Former
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Tobacco Use
Never
|
14 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Pre-operative, 2 weeks, and 6 weeks post-operativePopulation: Pre-operatively, 20 subjects were analyzed per arm. Due to subject withdrawal, 19 were available in Group 1 at 2 weeks; and only 16 were available in Group 1 at 6 weeks, and 10 were available in Group 2 at 6 weeks.
Magnetic resonance imaging (MRI) scans were conducted preoperatively and postoperatively at weeks 2 and 6 to measure cross sectional muscle volumes of the calf muscle. By measuring the muscle volume, the investigators hope to show the use of electrical stimulation will reduce calf muscle atrophy.
Outcome measures
| Measure |
Group 1- Compex® Muscle Stimulator
n=20 Participants
Group 1 will receive an active muscle stimulator, which will be placed immediately following surgery. Eight electrodes will be placed on the lower leg: four electrodes on the gastrocnemius (calf muscle), and two electrodes each on the lateral gastrocnemius (side) and anterior tibialis muscle (front). Subjects will use the stimulator for three 20 minute sessions per day.
Compex® muscle stimulator: The Compex® muscle stimulator is a commercially available muscle stimulator that is approved by the Food and Drug Administration (FDA), a governmental body. It is not investigational. The investigational part of this study aims to evaluate if the use of muscle simulation after Achilles tendon surgery will reduce calf atrophy.
|
Group 2 -(Inactive) Muscle Stimulator
n=20 Participants
Group 2 will receive a placebo (inactive) muscle stimulator, which will be placed immediately following surgery. Eight electrodes will be placed on the lower leg: four electrodes on the gastrocnemius (calf muscle), and two electrodes each on the lateral gastrocnemius (side) and anterior tibialis muscle (front). Subjects will be instructed to use the stimulator for three 20 minute sessions per day.
(inactive) muscle stimulator: A placebo (inactive) muscle stimulator, which will be placed immediately following surgery. Eight electrodes will be placed on the lower leg: four electrodes on the gastrocnemius (calf muscle), and two electrodes each on the lateral gastrocnemius (side) and anterior tibialis muscle (front). Subjects will be instructed to use the stimulator for three 20 minute sessions per day.
|
|---|---|---|
|
Reduce Calf Muscle Atrophy
Pre-operative Soleus
|
1962.2 mm^2
Standard Deviation 456.6
|
2250.5 mm^2
Standard Deviation 701.9
|
|
Reduce Calf Muscle Atrophy
Pre-operative Lateral Gastrocnemius
|
859.8 mm^2
Standard Deviation 230.1
|
874.9 mm^2
Standard Deviation 228.4
|
|
Reduce Calf Muscle Atrophy
Pre-operative Medial Gastrocnemius
|
1450.4 mm^2
Standard Deviation 392.1
|
1634.9 mm^2
Standard Deviation 378.2
|
|
Reduce Calf Muscle Atrophy
2 weeks post-operative Lateral Gastrocnemius
|
754.5 mm^2
Standard Deviation 184.4
|
780.9 mm^2
Standard Deviation 217.3
|
|
Reduce Calf Muscle Atrophy
2 weeks post-operative Medial Gastrocnemius
|
1348.1 mm^2
Standard Deviation 420.7
|
1432.8 mm^2
Standard Deviation 324.0
|
|
Reduce Calf Muscle Atrophy
2 weeks post-operative Soleus
|
1835.7 mm^2
Standard Deviation 461.0
|
2057.0 mm^2
Standard Deviation 646.7
|
|
Reduce Calf Muscle Atrophy
6 weeks post-operative Lateral Gastrocnemius
|
729.4 mm^2
Standard Deviation 195.6
|
722.9 mm^2
Standard Deviation 191.6
|
|
Reduce Calf Muscle Atrophy
6 weeks post-operative Medial Gastrocnemius
|
1242.1 mm^2
Standard Deviation 418.6
|
1316.2 mm^2
Standard Deviation 309.7
|
|
Reduce Calf Muscle Atrophy
6 weeks post-operative Soleus
|
1780.3 mm^2
Standard Deviation 471.3
|
1907.5 mm^2
Standard Deviation 586.4
|
Adverse Events
Group 1- Compex® Muscle Stimulator
Serious events: 2 serious events
Other events: 9 other events
Deaths: 0 deaths
Group 2 -(Inactive) Muscle Stimulator
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1- Compex® Muscle Stimulator
n=20 participants at risk
Group 1 will receive an active muscle stimulator, which will be placed immediately following surgery. Eight electrodes will be placed on the lower leg: four electrodes on the gastrocnemius (calf muscle), and two electrodes each on the lateral gastrocnemius (side) and anterior tibialis muscle (front). Subjects will use the stimulator for three 20 minute sessions per day.
Compex® muscle stimulator: The Compex® muscle stimulator is a commercially available muscle stimulator that is approved by the Food and Drug Administration (FDA), a governmental body. It is not investigational. The investigational part of this study aims to evaluate if the use of muscle simulation after Achilles tendon surgery will reduce calf atrophy.
|
Group 2 -(Inactive) Muscle Stimulator
n=20 participants at risk
Group 2 will receive a placebo (inactive) muscle stimulator, which will be placed immediately following surgery. Eight electrodes will be placed on the lower leg: four electrodes on the gastrocnemius (calf muscle), and two electrodes each on the lateral gastrocnemius (side) and anterior tibialis muscle (front). Subjects will be instructed to use the stimulator for three 20 minute sessions per day.
(inactive) muscle stimulator: A placebo (inactive) muscle stimulator, which will be placed immediately following surgery. Eight electrodes will be placed on the lower leg: four electrodes on the gastrocnemius (calf muscle), and two electrodes each on the lateral gastrocnemius (side) and anterior tibialis muscle (front). Subjects will be instructed to use the stimulator for three 20 minute sessions per day.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Achilles Tendon Re-ruptured
|
5.0%
1/20 • Number of events 1 • 3 years
|
0.00%
0/20 • 3 years
|
|
Blood and lymphatic system disorders
Deep Vein Thrombosis
|
5.0%
1/20 • Number of events 1 • 3 years
|
0.00%
0/20 • 3 years
|
|
Infections and infestations
MRSA infection
|
0.00%
0/20 • 3 years
|
5.0%
1/20 • Number of events 1 • 3 years
|
Other adverse events
| Measure |
Group 1- Compex® Muscle Stimulator
n=20 participants at risk
Group 1 will receive an active muscle stimulator, which will be placed immediately following surgery. Eight electrodes will be placed on the lower leg: four electrodes on the gastrocnemius (calf muscle), and two electrodes each on the lateral gastrocnemius (side) and anterior tibialis muscle (front). Subjects will use the stimulator for three 20 minute sessions per day.
Compex® muscle stimulator: The Compex® muscle stimulator is a commercially available muscle stimulator that is approved by the Food and Drug Administration (FDA), a governmental body. It is not investigational. The investigational part of this study aims to evaluate if the use of muscle simulation after Achilles tendon surgery will reduce calf atrophy.
|
Group 2 -(Inactive) Muscle Stimulator
n=20 participants at risk
Group 2 will receive a placebo (inactive) muscle stimulator, which will be placed immediately following surgery. Eight electrodes will be placed on the lower leg: four electrodes on the gastrocnemius (calf muscle), and two electrodes each on the lateral gastrocnemius (side) and anterior tibialis muscle (front). Subjects will be instructed to use the stimulator for three 20 minute sessions per day.
(inactive) muscle stimulator: A placebo (inactive) muscle stimulator, which will be placed immediately following surgery. Eight electrodes will be placed on the lower leg: four electrodes on the gastrocnemius (calf muscle), and two electrodes each on the lateral gastrocnemius (side) and anterior tibialis muscle (front). Subjects will be instructed to use the stimulator for three 20 minute sessions per day.
|
|---|---|---|
|
Infections and infestations
Sinus Infection
|
0.00%
0/20 • 3 years
|
5.0%
1/20 • Number of events 1 • 3 years
|
|
Skin and subcutaneous tissue disorders
Achilles Incision irritation
|
10.0%
2/20 • Number of events 2 • 3 years
|
0.00%
0/20 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Severe muscle discomfort
|
5.0%
1/20 • Number of events 1 • 3 years
|
0.00%
0/20 • 3 years
|
|
Skin and subcutaneous tissue disorders
Achilles wound dehiscence
|
5.0%
1/20 • Number of events 1 • 3 years
|
5.0%
1/20 • Number of events 1 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Increased ankle pain due to fall
|
0.00%
0/20 • 3 years
|
15.0%
3/20 • Number of events 3 • 3 years
|
|
Skin and subcutaneous tissue disorders
Skin irritation around electrode pads
|
10.0%
2/20 • Number of events 2 • 3 years
|
0.00%
0/20 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Knee pain and clicking
|
0.00%
0/20 • 3 years
|
5.0%
1/20 • Number of events 1 • 3 years
|
|
General disorders
Tooth pain
|
0.00%
0/20 • 3 years
|
5.0%
1/20 • Number of events 1 • 3 years
|
|
Ear and labyrinth disorders
Ear Infection
|
5.0%
1/20 • Number of events 1 • 3 years
|
0.00%
0/20 • 3 years
|
|
Skin and subcutaneous tissue disorders
Non-infected clear discharge from Achilles incision
|
5.0%
1/20 • Number of events 1 • 3 years
|
0.00%
0/20 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Diagnosed with Bell's Palsy
|
5.0%
1/20 • Number of events 1 • 3 years
|
0.00%
0/20 • 3 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place