Effect of Neural Mobilization on Lumbosacral Radiculopathy Patients With Peripheral Sensitization

Effect of Neural Mobilization Techniques on Pain, and Hip and Knee Range of Motion on Lumbosacral Radiculopathy Patients With Peripheral Sensitization

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.

Study Overview

• Status: Completed
• Conditions: Radiculopathy
• Intervention / Treatment: Other: Transcutaneous Electrical Nerve Stimulation (TENS); Other: Neural mobilization exercises -Tensioner technique; Other: Neural mobilization exercises -Slider technique

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.

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / 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 Names: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale	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)	The measurements were taken at days "0,1,5,12"
Hip Flexion Range of Motion (Symptomatic Side)	Change in Hip flexion range of motion during straight leg raising (symptomatic side)	The measurements were taken at days "0,1,5,12"
Knee Flexion Range of Motion (Symptomatic Side)	Change in Knee flexion range of motion during slump (symptomatic side)	The measurements were taken at days "0,1,5,12"
Hip Flexion Range of Motion (Asymptomatic Side)	Change in Hip Flexion Range of Motion During Straight Leg Raising (Asymptomatic Side)	The measurements were taken at days "0,1,5,12"
Knee Flexion Range of Motion (Asymptomatic Side)	Change in Knee flexion range of motion during slump (Asymptomatic side)	The measurements were taken at days "0,1,5,12"

Collaborators and Investigators

• Sponsor: Mohammed Al-Ghamdi

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2015
• Primary Completion (Actual): November 28, 2017
• Study Completion (Actual): March 30, 2018

Study Registration Dates

• First Submitted: July 30, 2018
• First Submitted That Met QC Criteria: August 8, 2018
• First Posted (Actual): August 9, 2018

Study Record Updates

• Last Update Posted (Actual): March 1, 2023
• Last Update Submitted That Met QC Criteria: February 28, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Lumbosacral radiculopathy; Neural mobilization; peripheral sensitization; radicular LBP; slider; tensioner
• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Radiculopathy
• Other Study ID Numbers: IRB-2014-04-321

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No