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NCT03621878

Effect of Neural Mobilization on Lumbosacral Radiculopathy Patients With Peripheral Sensitization

Completed NA Results posted Last updated 1 March 2023
What this trial tests

NA trial testing Neural mobilization exercises -Tensioner technique in Radiculopathy in 51 participants. Completed in 30 March 2018.

Timeline
1 July 2015
Primary endpoint
28 November 2017
30 March 2018

Quick facts

Lead sponsorMohammed Al-Ghamdi
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment51
Start date1 July 2015
Primary completion28 November 2017
Estimated completion30 March 2018

Drugs / interventions tested

Conditions studied

Sponsor

Mohammed Al-Ghamdi

Who can join

Adults 18 to 60, male only, with Radiculopathy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Visual Analog Scale Primary · 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)

Basline
GroupValue95% CI
Control Group5.638± 1.75762
Slider Group5.050± 2.15029
Tensioner Group5.094± 1.95015
After 1st Day
GroupValue95% CI
Control Group4.894± 1.86001
Slider Group4.759± 1.99125
Tensioner Group3.576± 2.22810
After 5th Day
GroupValue95% CI
Control Group5.100± 1.87508
Slider Group3.556± 2.21613
Tensioner Group2.606± 2.02005
After 12th Day
GroupValue95% CI
Control Group4.665± 1.74676
Slider Group2.626± 2.23538
Tensioner Group2.082± 1.56734
Hip Flexion Range of Motion (Symptomatic Side) Primary · The measurements were taken at days "0,1,5,12"

Change in Hip flexion range of motion during straight leg raising (symptomatic side)

Baseline
GroupValue95% CI
Control Group51.82± 15.314
Slider Group57.71± 16.042
Tensioner Group46.29± 16.243
After 1st Day
GroupValue95% CI
Control Group58.53± 13.884
Slider Group63.59± 15.452
Tensioner Group58.88± 16.714
After 5th Day
GroupValue95% CI
Control Group59.24± 14.338
Slider Group67.47± 15.412
Tensioner Group62.82± 13.956
After 12th Day
GroupValue95% CI
Control Group57.71± 17.944
Slider Group74.41± 22.327
Tensioner Group68.59± 12.555
Knee Flexion Range of Motion (Symptomatic Side) Primary · The measurements were taken at days "0,1,5,12"

Change in Knee flexion range of motion during slump (symptomatic side)

Baseline
GroupValue95% CI
Control Group52.29± 17.395
Slider Group45.647± 18.435
Tensioner Group47.059± 14.545
After 1st Day
GroupValue95% CI
Control Group49.41± 17.603
Slider Group31.294± 12.133
Tensioner Group34.824± 15.509
After 5th Day
GroupValue95% CI
Control Group48± 14.018
Slider Group31.412± 14.590
Tensioner Group31.765± 14.342
After 12th Day
GroupValue95% CI
Control Group47± 16.733
Slider Group26.882± 15.419
Tensioner Group64.47± 25.529
Hip Flexion Range of Motion (Asymptomatic Side) Primary · The measurements were taken at days "0,1,5,12"

Change in Hip Flexion Range of Motion During Straight Leg Raising (Asymptomatic Side)

Baseline
GroupValue95% CI
Control Group70.00± 15.313
Slider Group71.824± 20.467
Tensioner Group63.59± 15.407
After 1st Day
GroupValue95% CI
Control Group69.41± 17.044
Slider Group70.82± 20.944
Tensioner Group69.12± 13.114
After 5th Day
GroupValue95% CI
Control Group71.12± 11.146
Slider Group74.12± 18.721
Tensioner Group72.12± 11.033
After 12th Day
GroupValue95% CI
Control Group73.06± 12.920
Slider Group74.88± 19.251
Tensioner Group72.47± 10.869
Knee Flexion Range of Motion (Asymptomatic Side) Primary · The measurements were taken at days "0,1,5,12"

Change in Knee flexion range of motion during slump (Asymptomatic side)

Baseline
GroupValue95% CI
Control Group31.1176± 19.70052
Slider Group31.7059± 12.01439
Tensioner Group28.8824± 18.01001
After 1st Day
GroupValue95% CI
Control Group30.41± 22.319
Slider Group24.06± 13.831
Tensioner Group26.06± 14.528
After 5th Day
GroupValue95% CI
Control Group28.94± 18.216
Slider Group28.76± 19.250
Tensioner Group23.88± 13.453
After 12th Day
GroupValue95% CI
Control Group24.88± 17.517
Slider Group22.29± 16.669
Tensioner Group20.35± 12.639

Sponsor's own description

The primary purpose of this study was to investigate the effects of slider and tensioner techniques on pain, hip and knee ROM in lumbosacral radiculopathy patients with peripheral sensitization. A secondary purpose was to evaluate the correlation between these outcomes measurements.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Effect of Neural Mobilization Exercises in Patients With Low Back-Related Leg Pain With Peripheral Nerve Sensitization: A Prospective, Controlled Trial.
    Alshami AM, Alghamdi MA, Abdelsalam MS. · · 2021 · cited 13× · PMID 34987322 · DOI 10.1016/j.jcm.2021.07.001

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03621878.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing