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Completed

NCT Number: NCT03468439

Ultrasound and Peripheral Nerve Stimulator Guided Femoral Nerve Block

A pre-post descriptive study was performed to examine the immediate effects of ultrasound (US) guided femoral nerve block with phenol (UGFNBwP) in managing lower limb spasticity of individuals with traumatic spinal cord injury (SCI).

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Study Design: A pre-post descriptive study was performed. Objectives: To examine the immediate effects of ultrasound (US) guided femoral nerve block with phenol (UGFNBwP) in managing lower limb spasticity of individuals with traumatic spinal cord injury (SCI).

Setting: Ankara, Turkey Methods: Nineteen patients with traumatic SCI presenting with lower extremity spasticity were treated with UGFNBwP. Modified Ashworth Scale (MAS) of hip flexion and knee extension, functional independence measure (FIM) motor subscale, difficulty of catheterization (DoC), hygiene score (HS), spasm frequency (SF), sleep quality (SQ) and patient satisfaction (PS) were measured in all patients prior to treatment, at first week and second month.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Traumatic etiology
  • Duration of spinal cord injury more than twelve months
  • Spasticity of hip flexor and/or knee extensor muscle
  • Use of any oral medications to reduce spasticity at stable doses for at least one month before first assessment
  • The patients have to accept to continue same dose until end of the last assessment
  • Medical clearance to participate

Exclusion criteria

  • Having established contracture of the knee/hip joint
  • Aged over 65 years
  • History of surgery for knee/hip disorders
  • Non-traumatic etiology

Treatment and study plan

Femoral nerve block with phenol

Other

Primary outcomes

  1. Modified Ashworth Scale

    Time frame: up to 8 weeks

    Scale measures muscle tone (spasticity). (min-max:0-4).Higher values represent a worse outcome.

Secondary outcomes

  1. Functional independence measure

    Time frame: up to 8 weeks

    Scale measures level of independence on activities of daily life (min-max: 0-126) points).Motor subscale of FIM measure is used in this study (min-max:0-91). Higher values represent a better outcome.

Sponsors and collaborators

Lead sponsor

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Other

Registry information

Official study title

Short Term Effect of Ultrasound and Peripheral Nerve Stimulator Guided Femoral Nerve Block With Phenol on Outcomes in People With Traumatic Spinal Cord Injury

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Mar 16, 2018
Registry last updated
Mar 16, 2018

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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