Ultrasound and Peripheral Nerve Stimulator Guided Femoral Nerve Block

NCT ID: NCT03468439

Last Updated: 2018-03-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2016-12-31

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.

Conditions

Spinal Cord Injuries

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

femoral nerve block

Group Type: OTHER

Femoral nerve block with phenol

Intervention Type: OTHER

Interventions

Femoral nerve block with phenol

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yasin Demir

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

001

Identifier Type: -

Identifier Source: org_study_id