Effect of Neural Mobilization on Lumbosacral Radiculopathy Patients With Peripheral Sensitization

NCT ID: NCT03621878

Last Updated: 2023-03-01

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-01

Study Completion Date

2018-03-30

Brief Summary

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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

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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.

Conditions

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Radiculopathy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors
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.

Study Groups

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Control group

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

Group Type ACTIVE_COMPARATOR

Transcutaneous Electrical Nerve Stimulation (TENS)

Intervention Type OTHER

Electrotherapy device aiming to decrease patient's symptoms.

Tensioner Group

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

Group Type EXPERIMENTAL

Neural mobilization exercises -Tensioner technique

Intervention Type OTHER

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

Slider Group

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

Group Type EXPERIMENTAL

Neural mobilization exercises -Slider technique

Intervention Type OTHER

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

Interventions

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Neural mobilization exercises -Tensioner technique

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

Intervention Type OTHER

Neural mobilization exercises -Slider technique

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

Intervention Type OTHER

Transcutaneous Electrical Nerve Stimulation (TENS)

Electrotherapy device aiming to decrease patient's symptoms.

Intervention Type OTHER

Other Intervention Names

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Control

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Mohammed Al-Ghamdi

OTHER

Sponsor Role lead

Responsible Party

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Mohammed Al-Ghamdi

Physical Therapist

Responsibility Role SPONSOR_INVESTIGATOR

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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IRB-2014-04-321

Identifier Type: -

Identifier Source: org_study_id

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