Trial Outcomes & Findings for Effect of Neural Mobilization on Lumbosacral Radiculopathy Patients With Peripheral Sensitization (NCT NCT03621878)
NCT ID: NCT03621878
Last Updated: 2023-03-01
Results Overview
Visual analog scale was used to measure pain intensity. This scale is a 10 cm line where patients chose from 0 to 10 (when 0 mean no pain and 10 mean maximum pain)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
51 participants
Primary outcome timeframe
The measurements were taken at days "0,1,5,12"
Results posted on
2023-03-01
Participant Flow
Participant milestones
| Measure |
Control Group
patients in this group had 6 session of Transcutaneous Electric Nerve Stimulation in 2 weeks.
Transcutaneous Electric Nerve Stimulation: electric current produced by a device to stimulate the nerves for pain management
|
Tensioner Group
patients in this group had 6 session of TENS combined with Neural mobilization exercises -Tensioner technique in 2 weeks.
Neural mobilization exercises -Tensioner technique: a maneuver was done to increase the tension by lengthening the neural structure
Transcutaneous Electric Nerve Stimulation: electric current produced by a device to stimulate the nerves for pain management
|
Slider Group
patients in this group had 6 session of TENS combined with Neural mobilization exercises -Slider technique in 2 weeks.
Neural mobilization exercises -Slider technique: maneuver that produces a sliding motion between the neural tissues and the surrounding structures
Transcutaneous Electric Nerve Stimulation: electric current produced by a device to stimulate the nerves for pain management
|
|---|---|---|---|
|
Overall Study
STARTED
|
17
|
17
|
17
|
|
Overall Study
COMPLETED
|
17
|
17
|
17
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Control Group
n=17 Participants
patients in this group had 6 session of Transcutaneous Electric Nerve Stimulation in 2 weeks.
Transcutaneous Electric Nerve Stimulation: electric current produced by a device to stimulate the nerves for pain management
|
Tensioner Group
n=17 Participants
patients in this group had 6 session of TENS combined with Neural mobilization exercises -Tensioner technique in 2 weeks.
Neural mobilization exercises -Tensioner technique: a maneuver was done to increase the tension by lengthening the neural structure
Transcutaneous Electric Nerve Stimulation: electric current produced by a device to stimulate the nerves for pain management
|
Slider Group
n=17 Participants
patients in this group had 6 session of TENS combined with Neural mobilization exercises -Slider technique in 2 weeks.
Neural mobilization exercises -Slider technique: maneuver that produces a sliding motion between the neural tissues and the surrounding structures
Transcutaneous Electric Nerve Stimulation: electric current produced by a device to stimulate the nerves for pain management
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
40.24 years
STANDARD_DEVIATION 9.49 • n=17 Participants
|
33.53 years
STANDARD_DEVIATION 8.64 • n=17 Participants
|
36.82 years
STANDARD_DEVIATION 8.01 • n=17 Participants
|
36.86 years
STANDARD_DEVIATION 8.99 • n=51 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=17 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=51 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=17 Participants
|
17 Participants
n=17 Participants
|
17 Participants
n=17 Participants
|
51 Participants
n=51 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
body mass insex
|
27.08 Kg/m^2
STANDARD_DEVIATION 3.83 • n=17 Participants
|
28.23 Kg/m^2
STANDARD_DEVIATION 6.04 • n=17 Participants
|
28.19 Kg/m^2
STANDARD_DEVIATION 5.60 • n=17 Participants
|
27.83 Kg/m^2
STANDARD_DEVIATION 5.16 • n=51 Participants
|
|
Pain
|
5.63 Centimeters
STANDARD_DEVIATION 1.75 • n=17 Participants
|
5.09 Centimeters
STANDARD_DEVIATION 1.95 • n=17 Participants
|
5.05 Centimeters
STANDARD_DEVIATION 2.15 • n=17 Participants
|
5.26 Centimeters
STANDARD_DEVIATION 1.93 • n=51 Participants
|
PRIMARY outcome
Timeframe: The measurements were taken at days "0,1,5,12"Visual analog scale was used to measure pain intensity. This scale is a 10 cm line where patients chose from 0 to 10 (when 0 mean no pain and 10 mean maximum pain)
Outcome measures
| Measure |
Control Group
n=17 Participants
patients in this group had 6 session of Transcutaneous Electric Nerve Stimulation in 2 weeks.
Transcutaneous Electric Nerve Stimulation: electric current produced by a device to stimulate the nerves for pain management
|
Slider Group
n=17 Participants
patients in this group had 6 session of TENS combined with Neural mobilization exercises -Slider technique in 2 weeks.
Neural mobilization exercises -Slider technique: maneuver that produces a sliding motion between the neural tissues and the surrounding structures
Transcutaneous Electric Nerve Stimulation: electric current produced by a device to stimulate the nerves for pain management
|
Tensioner Group
n=17 Participants
patients in this group had 6 session of TENS combined with Neural mobilization exercises -Tensioner technique in 2 weeks.
Neural mobilization exercises -Tensioner technique: a maneuver was done to increase the tension by lengthening the neural structure
Transcutaneous Electric Nerve Stimulation: electric current produced by a device to stimulate the nerves for pain management
|
|---|---|---|---|
|
Visual Analog Scale
Basline
|
5.638 Centimeters
Standard Deviation 1.75762
|
5.050 Centimeters
Standard Deviation 2.15029
|
5.094 Centimeters
Standard Deviation 1.95015
|
|
Visual Analog Scale
After 1st Day
|
4.894 Centimeters
Standard Deviation 1.86001
|
4.759 Centimeters
Standard Deviation 1.99125
|
3.576 Centimeters
Standard Deviation 2.22810
|
|
Visual Analog Scale
After 5th Day
|
5.100 Centimeters
Standard Deviation 1.87508
|
3.556 Centimeters
Standard Deviation 2.21613
|
2.606 Centimeters
Standard Deviation 2.02005
|
|
Visual Analog Scale
After 12th Day
|
4.665 Centimeters
Standard Deviation 1.74676
|
2.626 Centimeters
Standard Deviation 2.23538
|
2.082 Centimeters
Standard Deviation 1.56734
|
PRIMARY outcome
Timeframe: The measurements were taken at days "0,1,5,12"Change in Hip flexion range of motion during straight leg raising (symptomatic side)
Outcome measures
| Measure |
Control Group
n=17 Participants
patients in this group had 6 session of Transcutaneous Electric Nerve Stimulation in 2 weeks.
Transcutaneous Electric Nerve Stimulation: electric current produced by a device to stimulate the nerves for pain management
|
Slider Group
n=17 Participants
patients in this group had 6 session of TENS combined with Neural mobilization exercises -Slider technique in 2 weeks.
Neural mobilization exercises -Slider technique: maneuver that produces a sliding motion between the neural tissues and the surrounding structures
Transcutaneous Electric Nerve Stimulation: electric current produced by a device to stimulate the nerves for pain management
|
Tensioner Group
n=17 Participants
patients in this group had 6 session of TENS combined with Neural mobilization exercises -Tensioner technique in 2 weeks.
Neural mobilization exercises -Tensioner technique: a maneuver was done to increase the tension by lengthening the neural structure
Transcutaneous Electric Nerve Stimulation: electric current produced by a device to stimulate the nerves for pain management
|
|---|---|---|---|
|
Hip Flexion Range of Motion (Symptomatic Side)
Baseline
|
51.82 degrees
Standard Deviation 15.314
|
57.71 degrees
Standard Deviation 16.042
|
46.29 degrees
Standard Deviation 16.243
|
|
Hip Flexion Range of Motion (Symptomatic Side)
After 1st Day
|
58.53 degrees
Standard Deviation 13.884
|
63.59 degrees
Standard Deviation 15.452
|
58.88 degrees
Standard Deviation 16.714
|
|
Hip Flexion Range of Motion (Symptomatic Side)
After 5th Day
|
59.24 degrees
Standard Deviation 14.338
|
67.47 degrees
Standard Deviation 15.412
|
62.82 degrees
Standard Deviation 13.956
|
|
Hip Flexion Range of Motion (Symptomatic Side)
After 12th Day
|
57.71 degrees
Standard Deviation 17.944
|
74.41 degrees
Standard Deviation 22.327
|
68.59 degrees
Standard Deviation 12.555
|
PRIMARY outcome
Timeframe: The measurements were taken at days "0,1,5,12"Change in Knee flexion range of motion during slump (symptomatic side)
Outcome measures
| Measure |
Control Group
n=17 Participants
patients in this group had 6 session of Transcutaneous Electric Nerve Stimulation in 2 weeks.
Transcutaneous Electric Nerve Stimulation: electric current produced by a device to stimulate the nerves for pain management
|
Slider Group
n=17 Participants
patients in this group had 6 session of TENS combined with Neural mobilization exercises -Slider technique in 2 weeks.
Neural mobilization exercises -Slider technique: maneuver that produces a sliding motion between the neural tissues and the surrounding structures
Transcutaneous Electric Nerve Stimulation: electric current produced by a device to stimulate the nerves for pain management
|
Tensioner Group
n=17 Participants
patients in this group had 6 session of TENS combined with Neural mobilization exercises -Tensioner technique in 2 weeks.
Neural mobilization exercises -Tensioner technique: a maneuver was done to increase the tension by lengthening the neural structure
Transcutaneous Electric Nerve Stimulation: electric current produced by a device to stimulate the nerves for pain management
|
|---|---|---|---|
|
Knee Flexion Range of Motion (Symptomatic Side)
Baseline
|
52.29 degrees
Standard Deviation 17.395
|
45.647 degrees
Standard Deviation 18.435
|
47.059 degrees
Standard Deviation 14.545
|
|
Knee Flexion Range of Motion (Symptomatic Side)
After 1st Day
|
49.41 degrees
Standard Deviation 17.603
|
31.294 degrees
Standard Deviation 12.133
|
34.824 degrees
Standard Deviation 15.509
|
|
Knee Flexion Range of Motion (Symptomatic Side)
After 5th Day
|
48 degrees
Standard Deviation 14.018
|
31.412 degrees
Standard Deviation 14.590
|
31.765 degrees
Standard Deviation 14.342
|
|
Knee Flexion Range of Motion (Symptomatic Side)
After 12th Day
|
47 degrees
Standard Deviation 16.733
|
26.882 degrees
Standard Deviation 15.419
|
64.47 degrees
Standard Deviation 25.529
|
PRIMARY outcome
Timeframe: The measurements were taken at days "0,1,5,12"Change in Hip Flexion Range of Motion During Straight Leg Raising (Asymptomatic Side)
Outcome measures
| Measure |
Control Group
n=17 Participants
patients in this group had 6 session of Transcutaneous Electric Nerve Stimulation in 2 weeks.
Transcutaneous Electric Nerve Stimulation: electric current produced by a device to stimulate the nerves for pain management
|
Slider Group
n=17 Participants
patients in this group had 6 session of TENS combined with Neural mobilization exercises -Slider technique in 2 weeks.
Neural mobilization exercises -Slider technique: maneuver that produces a sliding motion between the neural tissues and the surrounding structures
Transcutaneous Electric Nerve Stimulation: electric current produced by a device to stimulate the nerves for pain management
|
Tensioner Group
n=17 Participants
patients in this group had 6 session of TENS combined with Neural mobilization exercises -Tensioner technique in 2 weeks.
Neural mobilization exercises -Tensioner technique: a maneuver was done to increase the tension by lengthening the neural structure
Transcutaneous Electric Nerve Stimulation: electric current produced by a device to stimulate the nerves for pain management
|
|---|---|---|---|
|
Hip Flexion Range of Motion (Asymptomatic Side)
Baseline
|
70.00 degrees
Standard Deviation 15.313
|
71.824 degrees
Standard Deviation 20.467
|
63.59 degrees
Standard Deviation 15.407
|
|
Hip Flexion Range of Motion (Asymptomatic Side)
After 1st Day
|
69.41 degrees
Standard Deviation 17.044
|
70.82 degrees
Standard Deviation 20.944
|
69.12 degrees
Standard Deviation 13.114
|
|
Hip Flexion Range of Motion (Asymptomatic Side)
After 5th Day
|
71.12 degrees
Standard Deviation 11.146
|
74.12 degrees
Standard Deviation 18.721
|
72.12 degrees
Standard Deviation 11.033
|
|
Hip Flexion Range of Motion (Asymptomatic Side)
After 12th Day
|
73.06 degrees
Standard Deviation 12.920
|
74.88 degrees
Standard Deviation 19.251
|
72.47 degrees
Standard Deviation 10.869
|
PRIMARY outcome
Timeframe: The measurements were taken at days "0,1,5,12"Change in Knee flexion range of motion during slump (Asymptomatic side)
Outcome measures
| Measure |
Control Group
n=17 Participants
patients in this group had 6 session of Transcutaneous Electric Nerve Stimulation in 2 weeks.
Transcutaneous Electric Nerve Stimulation: electric current produced by a device to stimulate the nerves for pain management
|
Slider Group
n=17 Participants
patients in this group had 6 session of TENS combined with Neural mobilization exercises -Slider technique in 2 weeks.
Neural mobilization exercises -Slider technique: maneuver that produces a sliding motion between the neural tissues and the surrounding structures
Transcutaneous Electric Nerve Stimulation: electric current produced by a device to stimulate the nerves for pain management
|
Tensioner Group
n=17 Participants
patients in this group had 6 session of TENS combined with Neural mobilization exercises -Tensioner technique in 2 weeks.
Neural mobilization exercises -Tensioner technique: a maneuver was done to increase the tension by lengthening the neural structure
Transcutaneous Electric Nerve Stimulation: electric current produced by a device to stimulate the nerves for pain management
|
|---|---|---|---|
|
Knee Flexion Range of Motion (Asymptomatic Side)
After 12th Day
|
24.88 degrees
Standard Deviation 17.517
|
22.29 degrees
Standard Deviation 16.669
|
20.35 degrees
Standard Deviation 12.639
|
|
Knee Flexion Range of Motion (Asymptomatic Side)
Baseline
|
31.1176 degrees
Standard Deviation 19.70052
|
31.7059 degrees
Standard Deviation 12.01439
|
28.8824 degrees
Standard Deviation 18.01001
|
|
Knee Flexion Range of Motion (Asymptomatic Side)
After 1st Day
|
30.41 degrees
Standard Deviation 22.319
|
24.06 degrees
Standard Deviation 13.831
|
26.06 degrees
Standard Deviation 14.528
|
|
Knee Flexion Range of Motion (Asymptomatic Side)
After 5th Day
|
28.94 degrees
Standard Deviation 18.216
|
28.76 degrees
Standard Deviation 19.250
|
23.88 degrees
Standard Deviation 13.453
|
Adverse Events
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Tensioner Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Slider Group
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
Mohammed Alghamdi
imam abdulrahman bin faisal university
Phone: +966556852888
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place