RadiculopathyNCT05269602
The Diagnostic Role of Adding the Hoffman Reflex Study for L5 Radiculopathy in the Electrodiagnostic Laboratory
An observational study of Radiculopathy and Hoffman's Reflex, run by TC Erciyes University at 2 sites in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Radiculopathy, Hoffman's Reflex
- How many people
- 58 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Dec 2017to 1 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Bilateral radicular symptoms
- Multiple levels of radiculopathy
- Diabetes
- Polyneuropathy
- Rheumatic diseases
- History of malignancies
Show all 13Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Gazi University Faculty of Medicine
Ankara, Besevler, 06500
Selcuk University Faculty of Medicine
Konya, Selcuklu, 42130
About this study
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.
Read the detailed 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.
- Conditions
- Radiculopathy, Hoffman's Reflex
- Keywords
- Electrodiagnosis
- Medical subject headings
- Radiculopathy, Reflex, Abnormal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Hoffman reflex latency
The Hoffman reflex latency evaluated after electromyography
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2022
- Study start1 Dec 2017
- Primary completion1 Dec 2018
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RadiculopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hasan Kara, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05269602
- Sponsor's protocol ID
- HKara1
- Status last verified
- Mar 2022
- First submitted
- 15 Feb 2022
- Last updated
- 22 Mar 2022
- Results posted
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Diagnostic Role of Adding the Hoffman Reflex Study for L5 Radiculopathy in the Electrodiagnostic Laboratory
- ClinicalTrials.gov ID
- NCT05269602
- Acronym / sponsor ID
- HKara1
- Conditions
- Radiculopathy, Hoffman's Reflex
- Keywords
- Electrodiagnosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 8 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (13 listed)
- Bilateral radicular symptoms
- Multiple levels of radiculopathy
- Diabetes
- Polyneuropathy
- Rheumatic diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The Hoffman reflex latency
Time frame: 1 day
The Hoffman reflex latency evaluated after electromyography
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Radiculopathy and Hoffman's Reflex, run by TC Erciyes University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Hoffman reflex latency (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2022.