Ultrasound and Peripheral Nerve Stimulator Guided Femoral Nerve Block

Not Applicable

Completed

• Conditions: Spinal Cord Injuries
• Interventions: Other: Femoral nerve block with phenol

• Registration Number: NCT03468439
• Lead Sponsor: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Brief 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).

Detailed 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.

Study Timeline

• Study Start: 2014-01
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Study First Submitted: 2018-02-27
• Status Verified: 2018-03
• Study First Submitted QC: 2018-03-11
• Last Update Submitted: 2018-03-11
• Study First Posted: 2018-03-16
• Last Update Posted: 2018-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
femoral nerve block	Femoral nerve block with phenol	-

Primary Outcome Measures

Name	Time	Method
Modified Ashworth Scale	up to 8 weeks	Scale measures muscle tone (spasticity). (min-max:0-4).Higher values represent a worse outcome.

Secondary Outcome Measures

Name	Time	Method
Functional independence measure	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.