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Effect of Neural Mobilization on Lumbosacral Radiculopathy Patients With Peripheral Sensitization

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ClinicalTrials.gov Identifier: NCT03621878
Recruitment Status : Completed
First Posted : August 9, 2018
Results First Posted : July 22, 2019
Last Update Posted : July 22, 2019
Sponsor:
Information provided by (Responsible Party):
Mohammed Al-Ghamdi, Imam Abdulrahman Bin Faisal University

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Care Provider, Outcomes Assessor);   Primary Purpose: Treatment
Condition Radiculopathy
Interventions Other: Neural mobilization exercises -Tensioner technique
Other: Neural mobilization exercises -Slider technique
Other: Transcutaneous Electrical Nerve Stimulation (TENS)
Enrollment 51
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Control Group Tensioner Group Slider Group
Hide Arm/Group Description

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

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

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

Period Title: Overall Study
Started [1] 17 17 17
Completed 17 17 17
Not Completed 0 0 0
[1]
the data from subject whom completed the trials only was used in the statistical analysis and result
Arm/Group Title Control Group Tensioner Group Slider Group Total
Hide Arm/Group Description

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

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

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 of all reporting groups
Overall Number of Baseline Participants 17 17 17 51
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 17 participants 17 participants 17 participants 51 participants
40.24  (9.49) 33.53  (8.64) 36.82  (8.01) 36.86  (8.99)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 17 participants 17 participants 51 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Male
17
 100.0%
17
 100.0%
17
 100.0%
51
 100.0%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
body mass insex  
Median (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 17 participants 17 participants 17 participants 51 participants
27.08  (3.83) 28.23  (6.04) 28.19  (5.60) 27.83  (5.16)
Pain   [1] 
Mean (Standard Deviation)
Unit of measure:  Centimeters
Number Analyzed 17 participants 17 participants 17 participants 51 participants
5.63  (1.75) 5.09  (1.95) 5.05  (2.15) 5.26  (1.93)
[1]
Measure Description: visual analog scale was used to measure pain intensity in the baseline measurement. this scale is a 10 cm line where patients chose from 0 to 10 (when 0 mean no pain and 10 mean maximum pain)
1.Primary Outcome
Title Visual Analog Scale
Hide Description 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)
Time Frame The measurements were taken at days "0,1,5,12"
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Group Slider Group Tensioner Group
Hide Arm/Group Description:

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

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

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

Overall Number of Participants Analyzed 17 17 17
Mean (Standard Deviation)
Unit of Measure: Centimeters
Basline 5.638  (1.75762) 5.050  (2.15029) 5.094  (1.95015)
After 1st Day 4.894  (1.86001) 4.759  (1.99125) 3.576  (2.22810)
After 5th Day 5.100  (1.87508) 3.556  (2.21613) 2.606  (2.02005)
After 12th Day 4.665  (1.74676) 2.626  (2.23538) 2.082  (1.56734)
2.Primary Outcome
Title Hip Flexion Range of Motion (Symptomatic Side)
Hide Description Change in Hip flexion range of motion during straight leg raising (symptomatic side)
Time Frame The measurements were taken at days "0,1,5,12"
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Group Slider Group Tensioner Group
Hide Arm/Group Description:

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

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

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

Overall Number of Participants Analyzed 17 17 17
Mean (Standard Deviation)
Unit of Measure: degrees
Baseline 51.82  (15.314) 57.71  (16.042) 46.29  (16.243)
After 1st Day 58.53  (13.884) 63.59  (15.452) 58.88  (16.714)
After 5th Day 59.24  (14.338) 67.47  (15.412) 62.82  (13.956)
After 12th Day 57.71  (17.944) 74.41  (22.327) 68.59  (12.555)
3.Primary Outcome
Title Knee Flexion Range of Motion (Symptomatic Side)
Hide Description Change in Knee flexion range of motion during slump (symptomatic side)
Time Frame The measurements were taken at days "0,1,5,12"
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Group Slider Group Tensioner Group
Hide Arm/Group Description:

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

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

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

Overall Number of Participants Analyzed 17 17 17
Mean (Standard Deviation)
Unit of Measure: degrees
Baseline 52.29  (17.395) 45.647  (18.435) 47.059  (14.545)
After 1st Day 49.41  (17.603) 31.294  (12.133) 34.824  (15.509)
After 5th Day 48  (14.018) 31.412  (14.590) 31.765  (14.342)
After 12th Day 47  (16.733) 26.882  (15.419) 64.47  (25.529)
4.Primary Outcome
Title Hip Flexion Range of Motion (Asymptomatic Side)
Hide Description Change in Hip Flexion Range of Motion During Straight Leg Raising (Asymptomatic Side)
Time Frame The measurements were taken at days "0,1,5,12"
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Group Slider Group Tensioner Group
Hide Arm/Group Description:

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

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

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

Overall Number of Participants Analyzed 17 17 17
Mean (Standard Deviation)
Unit of Measure: degrees
Baseline 70.00  (15.313) 71.824  (20.467) 63.59  (15.407)
After 1st Day 69.41  (17.044) 70.82  (20.944) 69.12  (13.114)
After 5th Day 71.12  (11.146) 74.12  (18.721) 72.12  (11.033)
After 12th Day 73.06  (12.920) 74.88  (19.251) 72.47  (10.869)
5.Primary Outcome
Title Knee Flexion Range of Motion (Asymptomatic Side)
Hide Description Change in Knee flexion range of motion during slump (Asymptomatic side)
Time Frame The measurements were taken at days "0,1,5,12"
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Group Slider Group Tensioner Group
Hide Arm/Group Description:

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

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

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

Overall Number of Participants Analyzed 17 17 17
Mean (Standard Deviation)
Unit of Measure: degrees
Baseline 31.1176  (19.70052) 31.7059  (12.01439) 28.8824  (18.01001)
After 1st Day 30.41  (22.319) 24.06  (13.831) 26.06  (14.528)
After 5th Day 28.94  (18.216) 28.76  (19.250) 23.88  (13.453)
After 12th Day 24.88  (17.517) 22.29  (16.669) 20.35  (12.639)
Time Frame data was collected in around 3 years
Adverse Event Reporting Description no participants was in risk of mortality or Serious Adverse Events because the participants in this study ware patients with mild low back pain and and all the treatment we used ware gentle and without any serious adverse effects.
 
Arm/Group Title Control Group Tensioner Group Slider Group
Hide Arm/Group Description

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

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

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

All-Cause Mortality
Control Group Tensioner Group Slider Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/17 (0.00%)   0/17 (0.00%)   0/17 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Control Group Tensioner Group Slider Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/17 (0.00%)   0/17 (0.00%)   0/17 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Control Group Tensioner Group Slider Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/17 (0.00%)   0/17 (0.00%)   0/17 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Mohammed Alghamdi
Organization: imam abdulrahman bin faisal university
Phone: +966556852888
EMail: mohdg.ios@gmail.com
Layout table for additonal information
Responsible Party: Mohammed Al-Ghamdi, Imam Abdulrahman Bin Faisal University
ClinicalTrials.gov Identifier: NCT03621878     History of Changes
Other Study ID Numbers: IRB-2014-04-321
First Submitted: July 30, 2018
First Posted: August 9, 2018
Results First Submitted: January 23, 2019
Results First Posted: July 22, 2019
Last Update Posted: July 22, 2019