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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

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Radiculopathy Other: Neural mobilization exercises -Tensioner technique Other: Neural mobilization exercises -Slider technique Other: Transcutaneous Electrical Nerve Stimulation (TENS) Not Applicable

Detailed Description:

Study design: Double-blind case-control trial. Methods: Fifty-one male lumbosacral radiculopathy patients with peripheral sensitization, were divided into one of the three groups: slider, tensioner, and control. The primary outcome measurements were visual analog scale (VAS) for pain, hip range of motion (ROM) during SLR test, and knee flexion ROM during slump test. The measurements were taken at baseline, after 1st, 3rd, and 6th session.

Statistical Analysis: A two-way mixed design analysis of variance (MANOVA) with post-hoc (Bonferonni Correction) was used to calculate the differences with Time (baseline, 1st,3rd,6th sessions) as a within-group factor and Group (control, slider, and tensioner) as a between-group factor. The effect size was calculated with Cohen's d. Pearson's correlation was used for correlation analysis.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Masking Description: both the examiner and the outcomes assessor where blinded to the participants groups. the primary investigator was also blind to the outcomes of each participant during the study period.
Primary Purpose: Treatment
Official Title: Effect of Neural Mobilization Techniques on Pain, and Hip and Knee Range of Motion on Lumbosacral Radiculopathy Patients With Peripheral Sensitization
Actual Study Start Date : July 1, 2015
Actual Primary Completion Date : November 28, 2017
Actual Study Completion Date : March 30, 2018

Arm Intervention/treatment
Active Comparator: Control group
Patients in this group had 6 sessions in 2 weeks of Transcutaneous Electric Nerve Stimulation (TENS).
Other: Transcutaneous Electrical Nerve Stimulation (TENS)
Electrotherapy device aiming to decrease patient's symptoms.
Other Name: Control

Experimental: Tensioner Group
Patients in this group had 6 sessions in 2 weeks of TENS combined with neural mobilization exercises (Tensioner technique).
Other: Neural mobilization exercises -Tensioner technique
Exercise aiming to lengthen the neural structure using more than one joint.

Experimental: Slider Group
Patients in this group had 6 sessions in 2 weeks of TENS combined with neural mobilization exercises (Slider technique).
Other: Neural mobilization exercises -Slider technique
Exercise aiming to slide/glide the neural structure using more than one joint.




Primary Outcome Measures :
  1. Visual Analog Scale [ Time Frame: 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)

  2. Hip Flexion Range of Motion (Symptomatic Side) [ Time Frame: The measurements were taken at days "0,1,5,12" ]
    Change in Hip flexion range of motion during straight leg raising (symptomatic side)

  3. Knee Flexion Range of Motion (Symptomatic Side) [ Time Frame: The measurements were taken at days "0,1,5,12" ]
    Change in Knee flexion range of motion during slump (symptomatic side)

  4. Hip Flexion Range of Motion (Asymptomatic Side) [ Time Frame: The measurements were taken at days "0,1,5,12" ]
    Change in Hip Flexion Range of Motion During Straight Leg Raising (Asymptomatic Side)

  5. Knee Flexion Range of Motion (Asymptomatic Side) [ Time Frame: The measurements were taken at days "0,1,5,12" ]
    Change in Knee flexion range of motion during slump (Asymptomatic side)



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with lumbosacral radiculopathy with dominant peripheral sensitization
  • patients with unilateral leg pain.
  • patient S-LANSS score > 12,
  • negative sensory and motor examination.
  • positive neural tissue provocation tests (straight leg raising test, slump test).
  • adult.
  • pain duration of more than 3 months.

Exclusion Criteria:

  • S-LANSS score ≥ 12,
  • motor or sensory deficits,
  • history of back or lower extremity surgeries,
  • bilateral referred pain,
  • patients with pacemakers, cardiovascular problems, epilepsy, active malignancy, dermatological conditions, and diminished pain sensation.
  Study Documents (Full-Text)

Documents provided by Mohammed Al-Ghamdi, Imam Abdulrahman Bin Faisal University:

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Responsible Party: Mohammed Al-Ghamdi, Physical Therapist, Imam Abdulrahman Bin Faisal University
ClinicalTrials.gov Identifier: NCT03621878     History of Changes
Other Study ID Numbers: IRB-2014-04-321
First Posted: August 9, 2018    Key Record Dates
Results First Posted: July 22, 2019
Last Update Posted: July 22, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mohammed Al-Ghamdi, Imam Abdulrahman Bin Faisal University:
Lumbosacral radiculopathy
peripheral sensitization
Neural mobilization
radicular LBP
slider
tensioner
Additional relevant MeSH terms:
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Radiculopathy
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases