NCT05269602

Brief Summary

The H-reflex is one of the most popular topics in reflexology and one of the late responses involved in routine nerve conduction studies in the electromyography (EMG) laboratory. The H-reflex is generally recorded from the gastrocnemius-soleus muscles (tibial H-reflex) by stimulating the tibial nerve in the lower extremity. Tibial H-reflex is a sensitive measurement for examining S1 radiculopathy. Although there are plenty of studies related to the Soleus muscle registered H-reflex in S1 radiculopathy in the literature, there is no study in which the H-reflex is used in L5 muscles in diagnosing L5 radiculopathies. The aim of this study is to investigate the effectiveness of the H-reflex by using a different method in the distinction between L5 and S1 radiculopathies.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
58

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2017

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

February 15, 2022

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 8, 2022

Completed
Last Updated

March 22, 2022

Status Verified

March 1, 2022

Enrollment Period

1 year

First QC Date

February 15, 2022

Last Update Submit

March 7, 2022

Conditions

Keywords

Electrodiagnosis

Outcome Measures

Primary Outcomes (1)

  • The Hoffman reflex latency

    The Hoffman reflex latency evaluated after electromyography

    1 day

Study Arms (2)

L5 Radiculopathy

Patients who have Lumbar 5 root compression with the Magnetic Resonance İmaging

S1 Radiculopathy

Patients who have Sacral 1 root compression with the Magnetic Resonance İmaging

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

A total of 58 patients admitted applied to the outpatient clinics due to unilateral radicular back pain and who had L5 or S1 root compression in magnetic resonance imaging (MRI) participated in this study.

You may qualify if:

  • Between 18 and 65 years of age
  • Low back pain for at least three months
  • Radicular pain in one extremity, disc herniation that matches painful dermatome and root compression in MRI(L5 or S1 root compression)
  • MRI and physical examination findings compatible with root compression
  • No contraindications to EMG.

You may not qualify if:

  • Bilateral radicular symptoms
  • Multiple levels of radiculopathy
  • Diabetes
  • Polyneuropathy
  • Rheumatic diseases
  • History of malignancies
  • Lumbosacral region spine surgery
  • Lumbar spinal stenosis
  • Spondylolisthesis
  • Previous peripheral neuropathy in the lower extremities
  • Different causes of radiculopathy other than disc herniation (e.g. tumor, osteophyte, facet hypertrophy and other)
  • Central system disorders
  • Muscular diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Gazi University Faculty of Medicine

Ankara, Besevler, 06500, Turkey (Türkiye)

Location

Selcuk University Faculty of Medicine

Konya, Selcuklu, 42130, Turkey (Türkiye)

Location

MeSH Terms

Conditions

RadiculopathyReflex, Abnormal

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor, physiatrist

Study Record Dates

First Submitted

February 15, 2022

First Posted

March 8, 2022

Study Start

December 1, 2017

Primary Completion

December 1, 2018

Study Completion

December 1, 2019

Last Updated

March 22, 2022

Record last verified: 2022-03

Locations