Trial Outcomes & Findings for Cramer Sports Motion Tape and Low Back Pain EMG (NCT NCT02122445)
NCT ID: NCT02122445
Last Updated: 2016-02-09
Results Overview
3 muscles during 4 exercises (ClamsR, Sidelying, StandingAB, ForwardBend) at 3 time points (Baseline\[T1\], Immediate post\[T2\], 24hrs\[T3\]), were analyzed in 20 subjects, totaling 720 data points. Maximal voluntary isometric contraction(MVIC) was assessed using the standard manual muscle testing positions. For each subject, the EMG signals of the muscles during the exercises were smoothed, rectified and analyzed using a root-mean-square algorithm and the greatest activation of each muscle was used. After the peak activation(PA) for each muscle was determined, it was compared to the MVIC of the reference exercise for the respective muscle group, and expressed as a percent of MVIC (%MVIC). In some cases the %MVIC is greater than 100% because the MVIC was assessed during a manual muscle test position. During an exercise some muscles generated greater PA and therefore when calculated the %MVIC was greater than 100%. Due to the amount of data, we have provided the Gmax %MVIC results.
COMPLETED
NA
20 participants
% Maximal Voluntary Isometric Contracion (%MVIC)
2016-02-09
Participant Flow
Low back pain patients, evaluated within the first 2 initial visits of treatment at an outpatient rehabilitation clinic.
Participant milestones
| Measure |
Low Back Pain
Lower body exercises before and after the application of Cramer Sports Motion tape
Cramer Sports Motion Tape: lower body exercises with and without Cramer Sports Motion tape applied to the hip
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cramer Sports Motion Tape and Low Back Pain EMG
Baseline characteristics by cohort
| Measure |
Low Back Pain
n=20 Participants
Lower body exercises before and after the application of Cramer Sports Motion tape
Cramer Sports Motion Tape: lower body exercises with and without Cramer Sports Motion tape applied to the hip
|
|---|---|
|
Age, Continuous
|
40.05 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: % Maximal Voluntary Isometric Contracion (%MVIC)3 muscles during 4 exercises (ClamsR, Sidelying, StandingAB, ForwardBend) at 3 time points (Baseline\[T1\], Immediate post\[T2\], 24hrs\[T3\]), were analyzed in 20 subjects, totaling 720 data points. Maximal voluntary isometric contraction(MVIC) was assessed using the standard manual muscle testing positions. For each subject, the EMG signals of the muscles during the exercises were smoothed, rectified and analyzed using a root-mean-square algorithm and the greatest activation of each muscle was used. After the peak activation(PA) for each muscle was determined, it was compared to the MVIC of the reference exercise for the respective muscle group, and expressed as a percent of MVIC (%MVIC). In some cases the %MVIC is greater than 100% because the MVIC was assessed during a manual muscle test position. During an exercise some muscles generated greater PA and therefore when calculated the %MVIC was greater than 100%. Due to the amount of data, we have provided the Gmax %MVIC results.
Outcome measures
| Measure |
Low Back Pain
n=20 Participants
Lower body exercises before and after the application of Cramer Sports Motion tape
Cramer Sports Motion Tape: lower body exercises with and without Cramer Sports Motion tape applied to the hip
|
|---|---|
|
Percent of Maximal Voluntary Isometric Contraction (%MVIC)
ClamsR Gmax T1
|
226.41 % of Max Voluntary Isometric Contraction
Interval 27.18 to 544.47
|
|
Percent of Maximal Voluntary Isometric Contraction (%MVIC)
ClamsR Gmax T2
|
250.51 % of Max Voluntary Isometric Contraction
Interval 39.28 to 1096.71
|
|
Percent of Maximal Voluntary Isometric Contraction (%MVIC)
ClamsR Gmax T3
|
162.47 % of Max Voluntary Isometric Contraction
Interval 15.15 to 938.65
|
|
Percent of Maximal Voluntary Isometric Contraction (%MVIC)
Sidelying Gmax T1
|
205.82 % of Max Voluntary Isometric Contraction
Interval 22.98 to 1253.38
|
|
Percent of Maximal Voluntary Isometric Contraction (%MVIC)
Sidelying Gmax T2
|
176.24 % of Max Voluntary Isometric Contraction
Interval 16.54 to 895.55
|
|
Percent of Maximal Voluntary Isometric Contraction (%MVIC)
Sidelying Gmax T3
|
139.20 % of Max Voluntary Isometric Contraction
Interval 14.13 to 668.71
|
|
Percent of Maximal Voluntary Isometric Contraction (%MVIC)
StandingAB Gmax T1
|
196.31 % of Max Voluntary Isometric Contraction
Interval 29.82 to 1057.82
|
|
Percent of Maximal Voluntary Isometric Contraction (%MVIC)
StandingAB Gmax T2
|
186.15 % of Max Voluntary Isometric Contraction
Interval 26.36 to 750.0
|
|
Percent of Maximal Voluntary Isometric Contraction (%MVIC)
StandingAB Gmax T3
|
124.84 % of Max Voluntary Isometric Contraction
Interval 35.25 to 550.1
|
|
Percent of Maximal Voluntary Isometric Contraction (%MVIC)
ForwardBend Gmax T1
|
54.34 % of Max Voluntary Isometric Contraction
Interval 24.64 to 127.1
|
|
Percent of Maximal Voluntary Isometric Contraction (%MVIC)
ForwardBend Gmax T2
|
55.57 % of Max Voluntary Isometric Contraction
Interval 19.78 to 167.64
|
|
Percent of Maximal Voluntary Isometric Contraction (%MVIC)
ForwardBend Gmax T3
|
52.05 % of Max Voluntary Isometric Contraction
Interval 11.86 to 123.36
|
SECONDARY outcome
Timeframe: Perceived ExertionThe amount of perceived exertion was reported for each of the 4 exercises (ClamsR, Sidelying, StandingAB, ForwardBend) at 3 time points (Baseline\[T1\], Immediate post\[T2\], 24hrs\[T3\]), by 20 subjects, totaling 240 data points. This was measured using the TheraBand(R) Resistance Intensity Scale for Exercise (RISE Scale). Participants were asked to rate their perceived exertion on a scale of 0 to 10, 0 being no resistance and 10 being maximum resistance. The results of the 20 subjects were averaged for each exercise at each time point.
Outcome measures
| Measure |
Low Back Pain
n=20 Participants
Lower body exercises before and after the application of Cramer Sports Motion tape
Cramer Sports Motion Tape: lower body exercises with and without Cramer Sports Motion tape applied to the hip
|
|---|---|
|
Perceived Exertion
Sidelying T3
|
2.15 units on a scale, from 0 to 10
Interval 0.0 to 5.0
|
|
Perceived Exertion
Clams T1
|
2.95 units on a scale, from 0 to 10
Interval 0.0 to 5.0
|
|
Perceived Exertion
Clams T2
|
2.6 units on a scale, from 0 to 10
Interval 0.0 to 5.0
|
|
Perceived Exertion
Clams T3
|
2.55 units on a scale, from 0 to 10
Interval 0.0 to 6.0
|
|
Perceived Exertion
Sidelying T1
|
2.75 units on a scale, from 0 to 10
Interval 1.0 to 6.0
|
|
Perceived Exertion
Sidelying T2
|
2.15 units on a scale, from 0 to 10
Interval 0.0 to 5.0
|
|
Perceived Exertion
StandingAB T1
|
3.1 units on a scale, from 0 to 10
Interval 0.0 to 6.0
|
|
Perceived Exertion
StandingAB T2
|
2.5 units on a scale, from 0 to 10
Interval 0.0 to 7.0
|
|
Perceived Exertion
StandingAB T3
|
2.4 units on a scale, from 0 to 10
Interval 0.0 to 6.0
|
|
Perceived Exertion
ForwardBend T1
|
3.5 units on a scale, from 0 to 10
Interval 0.0 to 8.0
|
|
Perceived Exertion
ForwardBend T2
|
2.3 units on a scale, from 0 to 10
Interval 0.0 to 8.0
|
|
Perceived Exertion
ForwardBend T3
|
2.5 units on a scale, from 0 to 10
Interval 0.0 to 6.0
|
Adverse Events
Low Back Pain
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Jena Slaski
Sport and Spine Rehab Clincal Research Foundation
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place