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Effect of Neural Mobilization on Lumbosacral Radiculopathy Patients With Peripheral Sensitization

Primary Purpose

Radiculopathy

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Neural mobilization exercises -Tensioner technique

Neural mobilization exercises -Slider technique

Transcutaneous Electrical Nerve Stimulation (TENS)

About this trial

This is an interventional treatment trial for Radiculopathy focused on measuring Lumbosacral radiculopathy, peripheral sensitization, Neural mobilization, radicular LBP, slider, tensioner

Eligibility Criteria

18 Years - 60 Years (Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Arm Label

Control group

Tensioner Group

Slider Group

Arm Description

Patients in this group had 6 sessions in 2 weeks of Transcutaneous Electric Nerve Stimulation (TENS).

Patients in this group had 6 sessions in 2 weeks of TENS combined with neural mobilization exercises (Tensioner technique).

Patients in this group had 6 sessions in 2 weeks of TENS combined with neural mobilization exercises (Slider technique).

Outcomes

Primary Outcome Measures

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)

Hip Flexion Range of Motion (Symptomatic Side)

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

Knee Flexion Range of Motion (Symptomatic Side)

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

Hip Flexion Range of Motion (Asymptomatic Side)

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

Knee Flexion Range of Motion (Asymptomatic Side)

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

Secondary Outcome Measures

Full Information

NCT ID

NCT03621878

First Posted

July 30, 2018

Last Updated

February 28, 2023

Sponsor

Mohammed Al-Ghamdi

1. Study Identification

Unique Protocol Identification Number

NCT03621878

Brief Title

Effect of Neural Mobilization on Lumbosacral Radiculopathy Patients With Peripheral Sensitization

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Completed

Study Start Date

July 1, 2015 (Actual)

Primary Completion Date

November 28, 2017 (Actual)

Study Completion Date

March 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Mohammed Al-Ghamdi

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Radiculopathy

Keywords

Lumbosacral radiculopathy, peripheral sensitization, Neural mobilization, radicular LBP, slider, tensioner

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Care ProviderOutcomes 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.

Allocation

Non-Randomized

Enrollment

51 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control group

Arm Type

Active Comparator

Arm Description

Patients in this group had 6 sessions in 2 weeks of Transcutaneous Electric Nerve Stimulation (TENS).

Arm Title

Tensioner Group

Arm Type

Experimental

Arm Description

Patients in this group had 6 sessions in 2 weeks of TENS combined with neural mobilization exercises (Tensioner technique).

Arm Title

Slider Group

Arm Type

Experimental

Arm Description

Patients in this group had 6 sessions in 2 weeks of TENS combined with neural mobilization exercises (Slider technique).

Intervention Type

Other

Intervention Name(s)

Neural mobilization exercises -Tensioner technique

Intervention Description

Exercise aiming to lengthen the neural structure using more than one joint.

Intervention Type

Other

Intervention Name(s)

Neural mobilization exercises -Slider technique

Intervention Description

Exercise aiming to slide/glide the neural structure using more than one joint.

Intervention Type

Other

Intervention Name(s)

Transcutaneous Electrical Nerve Stimulation (TENS)

Other Intervention Name(s)

Control

Intervention Description

Electrotherapy device aiming to decrease patient's symptoms.

Primary Outcome Measure Information:

Title

Visual Analog Scale

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