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Completed

NCT Number: NCT03621878

Effect of Neural Mobilization 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.

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Key information

Conditions

Radiculopathy Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases

Age range

18 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Neural mobilization exercises -Tensioner technique

Other

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

Neural mobilization exercises -Slider technique

Other

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

Transcutaneous Electrical Nerve Stimulation (TENS)

Other

Electrotherapy device aiming to decrease patient's symptoms.

Other names: Control

Primary outcomes

  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)

Sponsors and collaborators

Lead sponsor

Mohammed Al-Ghamdi

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Aug 9, 2018
Registry last updated
Mar 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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