Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05269602
Other study ID # HKara1
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 1, 2017
Est. completion date December 1, 2019

Study information

Verified date March 2022
Source TC Erciyes University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

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. Hoffman et al. developed a method for simultaneously evaluating the H-reflex obtained from different muscles with single peripheral nerve stimulation. With this method, H-reflex measurement can be done in three leg muscles, including the tibialis anterior, peroneus longus, and soleus with sciatic nerve stimulation. Thus, the L5 and S1 roots can be evaluated separately with a single stimulation. 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. The H-reflex was evaluated simultaneously using the method developed by Hoffman et al. using superficial recording electrodes in a 3-channel way from the Tibialis anterior, Peroneus Longus, and Soleus muscles. Latency was recorded when the maximum H-reflex amplitude was obtained. The onset H-reflex latency was marked and measured for each muscle. The patients were evaluated according to EMG and magnetic resonance imaging findings. The latency of the H-reflex was compared with the contralateral extremity in each group.


Recruitment information / eligibility

Status Completed
Enrollment 58
Est. completion date December 1, 2019
Est. primary completion date December 1, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Turkey Gazi University Faculty of Medicine Ankara Besevler
Turkey Selcuk University Faculty of Medicine Konya Selcuklu

Sponsors (1)

Lead Sponsor Collaborator
TC Erciyes University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary The Hoffman reflex latency The Hoffman reflex latency evaluated after electromyography 1 day
See also
  Status Clinical Trial Phase
Completed NCT03733886 - Burst Spinal Cord Stimulation for Neuropathic Pain. N/A
Completed NCT03835182 - Efficacy of Ultrasound Versus Short Wave Diathermy in the Treatment of a Slipped Disc of the Lower Back N/A
Completed NCT04169477 - Comparison of Two Modes of Transcutaneous Electrical Nerve Stimulation (TENS) in Chronic Neuropathic Radiculalgia N/A
Completed NCT02265848 - High Frequency Stimulation Trials in Patients With Precision Spinal Cord Stimulator System Phase 4
Not yet recruiting NCT05487690 - Application of 3D Printing Guide Plate in Spinal Minimally Invasive and Interventional Surgeries N/A
Recruiting NCT04909138 - Intermittent Dosing of Dorsal Root Ganglion Stimulation as an Alternate Paradigm to Continuous Low-Frequency Therapy N/A
Completed NCT05533723 - Comparison Between Endoscopic Epidural Neuroplasty and Percutaneous Epidural Neuroplasty in Low Back and Radicular Pain
Not yet recruiting NCT06041347 - Learning Curve for the Visualization of Sacral Plexus on TVS
Completed NCT02939482 - A Study Comparison of Clinical Outcome After Different Rate of Infusion in Caudal Epidural Steroid Injection N/A
Recruiting NCT05732818 - Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nuclectomy 3 N/A
Active, not recruiting NCT04559295 - Bone Marrow Concentrate (BMC) Injection in Intervertebral Discs Phase 2/Phase 3
Completed NCT02644421 - Clinical Trial to Evaluate the Safety and Analgesic Efficacy of VVZ-149 in Lumbar Radiculopathy (Sciatica) Phase 1
Recruiting NCT06193265 - Management of Lumbar Discectomy by Endoscopy and Conventional Microscopic Discectomy
Recruiting NCT05145842 - The Effect of Combination of Ultrasound and Flouroscopy Guidance in Caudal Epidural Injections N/A
Withdrawn NCT03327272 - Impact of Local Steroid Application in Extreme Lateral Lumbar Interbody Fusion Phase 3
Withdrawn NCT02196883 - Steroid Injections Given at the "Level of MRI Pathology" Versus at the "Level of Clinical Symptoms" to See if One is More Effective Than the Other. N/A
Terminated NCT01850771 - Regenexx™ PL-Disc Versus Steroid Epidurals for Lumbar Radiculopathy N/A
Completed NCT02130258 - Somatosensory Profiling in Radicular Pain Patients And it's Correlation With Treatment Outcome N/A
Withdrawn NCT05347108 - Real-Time Accurate Pathology Inspection and Decompression Study
Active, not recruiting NCT05696470 - Fusion Rates of 3D Printed Porous Titanium Cages in Three and Four Level ACDFs