NCT03468439

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2014

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

February 27, 2018

Completed
17 days until next milestone

First Posted

Study publicly available on registry

March 16, 2018

Completed
Last Updated

March 16, 2018

Status Verified

March 1, 2018

Enrollment Period

2.9 years

First QC Date

February 27, 2018

Last Update Submit

March 11, 2018

Conditions

Spinal Cord Injuries

Keywords

nerve block

Outcome Measures

Primary Outcomes (1)

  • Modified Ashworth Scale

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

    up to 8 weeks

Secondary Outcomes (1)

  • Functional independence measure

    up to 8 weeks

Study Arms (1)

femoral nerve block

OTHER
Other: Femoral nerve block with phenol

Interventions

Femoral nerve block with phenolOTHER
femoral nerve block

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Phenol

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 27, 2018

First Posted

March 16, 2018

Study Start

January 1, 2014

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

March 16, 2018

Record last verified: 2018-03