Ultrasound and Peripheral Nerve Stimulator Guided Femoral Nerve Block

Spinal Cord Injuries Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03468439
• Other study ID #: 001
• Status: Completed
• Phase: N/A
• First received: February 27, 2018
• Last updated: March 11, 2018
• Start date: January 2014
• Est. completion date: December 2016

Study information

• Verified date: March 2018
• Source: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Injuries

Intervention

Other:
• Femoral nerve block with phenol

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modified Ashworth Scale	Scale measures muscle tone (spasticity). (min-max:0-4).Higher values represent a worse outcome.	up to 8 weeks
Secondary	Functional independence measure	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.	up to 8 weeks