Chronic Low-back PainNCT05402904
Neurophysiological Assessment of Spinal Excitability in Chronic Low Back Pain
A study testing nerve conduction study in people with Chronic Low-back Pain, run by Sohag University at 1 site in Egypt.
Trial summary
Chronic low back pain (CLBP) is established by the persistence of low back pain beyond 3 months of symptom initiation . The overwhelming element of treatment is physical exercise . Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Low-back Pain
- What is being tested?
- nerve conduction study
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- Jun 2022to Feb 2023
- Phase
- Interventional
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients suffering from chronic low back pain for more than 12 Weeks.
Who cannot join
- Patients who are suspected of suffering from any autoimmune, rheumatological disorders that could explain the pain that they experienced will be excluded from the study.
- Patients who are suffering from any disease that could affect the results and interpretation of the parameters of the H-reflex, F-wave or SSEP, including polyneuropathy and radiculopathy.
- Patients who are suffering from any Structural Spinal cause of pain will be excluded by relative investigations.
Trial locations and contacts
1 site in 1 country.
Gharib F Mohamed, Professor contact
About this study
Chronic low back pain (CLBP) is established by the persistence of low back pain beyond 3 months of symptom initiation . The overwhelming element of treatment is physical exercise . Other methods of treatment like cognitive therapy, behavioural therapy and multidisciplinary rehabilitation can also lead to significant improvements 1.
Prevalenc of CLBP increases linearly from the third decade of life on, until the 60 years of age, being more prevalent in women.2 CLBP is a common condition affecting many individuals at some point in their lives.3 The estimation is that between 5.0% and 10.0% of cases will develop CLBP, which is responsible for high treatment costs, sick leave, and individual suffering, in addition to being one of the main reasons for people to seek health care services.4 CLBP and related disorders represent a wide spectrum of syndromes that are associated with changes in the pain processing pathways of the central nervous system .5 Those syndromes affect many systems in the body, and the associated plasticity changes in the CNS can lead to augmentation of pain transmission and processing circuits. 6,7 The pain in patients with CLBP occurs as a result of a process called central sensitization (CS), which refers to increased excitability of the neurons in the dorsal horn of the spinal cord. This increased excitability is associated with increased spontaneous neuronal activity, expanded receptive fields, and enhanced responses to the impulses transmitted by both large and small-fiber sensory afferents.8 The Hoffman reflex , F-wave and Somatosensory evoked potential (SSEP) are often used to measure spinal excitability in various physiological and pathological states.9-10 The H-reflex is elicited by stimulation of type Ia afferent sensory fibers. These fibers synapse directly onto the alpha motor neurons in the anterior horn of the spinal cord, forming a monosynaptic reflex arc. Submaximal stimulation of this reflex arc elicits a compound muscle action potential (CMAP) known as the H wave. This reflex arc appears to depend on the balance between excitatory and inhibitory neurons in the spinal cord . F wave is a late response that follows the motor response (M) and is elicited by supramaximal electrical stimulation of a mixed or a motor nerve.11 The study of the F waves is particularly useful for the diagnosis of proximal nerve lesions that would be otherwise inaccessible to other routine NCSs.12 SSEPs are also important complementary diagnostic methods in the electrophysiologic evaluation of CLBP. SSEPs are a very sensitive measure of the functional integrity of the neuroaxis, including peripheral and central structures. When used in diagnostic mode they can provide additional information regarding the probable areas of dysfunction.
Since a change in spinal excitability is one of the main mechanisms underlying the hypothesis of CS in CLBP, performing these tests might be an easy, widely available, cheap, and objective method for assessing spinal excitability in patients with CLBP.
- Conditions
- Chronic Low-back Pain
- Being tested
- nerve conduction study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nerve conduction studyDiagnostic test
Routine nerve conduction study on both lower limbs as well as F- wave , Hoffman reflex and somatosensory evoked potential.
| Study group | Role | What they receive |
|---|---|---|
| patients with chronic low back pain | Active comparator | 50 Patients will be recruited from neuropsychiatric outpatient clinic at Sohag University Hospital complaining of CLBP for more than 12 Weeks. Patients who are suspected of suffering from any autoimmune, rheumatological, or neurological disorders that could explain the pain that they experienced will be excluded from the study. Patients who are suffering from any disease that could affect the results and interpretation of the parameters of the H-reflex, F-wave or SSEP, including polyneuropathy and radiculopathy. Structural Spinal cause of pain will be excluded by relative investigations. Routine nerve conduction studies on both lower limbs as well as H-reflex, F-wave and SSEP will be performed on both patients and controls.Arabic versions of the Beck depression inventory and Taylor's Manifest Anxiety Scale will be used to measure depression and anxiety in both patients and healthy controls. Receives: Diagnostic Test: nerve conduction study |
| healthy controls | Active comparator | 50 Healthy volunteers will be included in the control group of the study. Routine nerve conduction studies on both lower limbs as well as H-reflex, F-wave and SSEP will be performed on both patients and controls.
Arabic versions of the Beck depression inventory and Taylor's Manifest Anxiety Scale (TMAS) will be used to measure depression and anxiety in both patients and healthy controls. Receives: Diagnostic Test: nerve conduction study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine hoffman reflex latency in patient with chronic low back pain
Hoffman reflex latency will be measures in patient with chronic low back pain to assess spinal excitability
Measured: 8 months
Determine F wave latency in patient with chronic low back pain
F wave latency will be measured in patient with chronic low back pain to assess spinal excitability
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2022
- Study startJun 2022 (estimated)
- Primary completionFeb 2023 (estimated)
- Study completionFeb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Low-back PainStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Kamel Khalaf, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05402904
- Sponsor's protocol ID
- Soh-Med-22-05-05
- Status last verified
- Jun 2022
- First submitted
- 15 May 2022
- Last updated
- 23 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Meucci RD, Fassa AG, Faria NM. Prevalence of chronic low back pain: systematic review. Rev Saude Publica. 2015;49:1. doi: 10.1590/S0034-8910.2015049005874. Epub 2015 Oct 20.
PubMed 26487293Knikou M, Murray LM. Repeated transspinal stimulation decreases soleus H-reflex excitability and restores spinal inhibition in human spinal cord injury. PLoS One. 2019 Sep 26;14(9):e0223135. doi: 10.1371/journal.pone.0223135. eCollection 2019.
PubMed 31557238Valat JP. Factors involved in progression to chronicity of mechanical low back pain. Joint Bone Spine. 2005 May;72(3):193-5. doi: 10.1016/j.jbspin.2004.07.010. No abstract available.
PubMed 15850987
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurophysiological Assessment of Spinal Excitability in Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT05402904
- Acronym / sponsor ID
- Soh-Med-22-05-05
- Conditions
- Chronic Low-back Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Jun 2022 (estimated)
- Primary completion
- Feb 2023 (estimated)
- Study completion
- Feb 2023 (estimated)
- First posted
- 2 Jun 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.
Chronic low back pain (CLBP) is established by the persistence of low back pain beyond 3 months of symptom initiation . The overwhelming element of treatment is physical exercise . Other methods of treatment like cognitive therapy, behavioural therapy and multidisciplinary rehabilitation can also lead to significant improvements 1.
Prevalenc of CLBP increases linearly from the third decade of life on, until the 60 years of age, being more prevalent in women.2 CLBP is a common condition affecting many individuals at some point in their lives.3 The estimation is that between 5.0% and 10.0% of cases will develop CLBP, which is responsible for high treatment costs, sick leave, and individual suffering, in addition to being one of the main reasons for people to seek health care services.4 CLBP and related disorders represent a wide spectrum of syndromes that are associated with changes in the pain processing pathways of the central nervous system .5 Those syndromes affect many systems in the body, and the associated plasticity changes in the CNS can lead to augmentation of pain transmission and processing circuits. 6,7 The pain in patients with CLBP occurs as a result of a process called central sensitization (CS), which refers to increased excitability of the neurons in the dorsal horn of the spinal cord. This increased excitability is associated with increased spontaneous neuronal activity, expanded receptive fields, and enhanced responses to the impulses transmitted by both large and small-fiber sensory afferents.8 The Hoffman reflex , F-wave and Somatosensory evoked potential (SSEP) are often used to measure spinal excitability in various physiological and pathological states.9-10 The H-reflex is elicited by stimulation of type Ia afferent sensory fibers. These fibers synapse directly onto the alpha motor neurons in the anterior horn of the spinal cord, forming a monosynaptic reflex arc. Submaximal stimulation of this reflex arc elicits a compound muscle action potential (CMAP) known as the H wave. This reflex arc appears to depend on the balance between excitatory and inhibitory neurons in the spinal cord . F wave is a late response that follows the motor response (M) and is elicited by supramaximal electrical stimulation of a mixed or a motor nerve.11 The study of the F waves is particularly useful for the diagnosis of proximal nerve lesions that would be otherwise inaccessible to other routine NCSs.12 SSEPs are also important complementary diagnostic methods in the electrophysiologic evaluation of CLBP. SSEPs are a very sensitive measure of the functional integrity of the neuroaxis, including peripheral and central structures. When used in diagnostic mode they can provide additional information regarding the probable areas of dysfunction.
Since a change in spinal excitability is one of the main mechanisms underlying the hypothesis of CS in CLBP, performing these tests might be an easy, widely available, cheap, and objective method for assessing spinal excitability in patients with CLBP.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with chronic low back pain | Active comparator | Diagnostic Test: nerve conduction study50 Patients will be recruited from neuropsychiatric outpatient clinic at Sohag University Hospital complaining of CLBP for more than 12 Weeks. Patients who are suspected of suffering from any autoimmune, rheumatological, or neurological disorders that could explain the pain that they experienced will be excluded from the study. Patients who are suffering from any disease that could affect the results and interpretation of the parameters of the H-reflex, F-wave or SSEP, including polyneuropathy and radiculopathy. Structural Spinal cause of pain will be excluded by relative investigations. Routine nerve conduction studies on both lower limbs as well as H-reflex, F-wave and SSEP will be performed on both patients and controls.Arabic versions of the Beck depression inventory and Taylor's Manifest Anxiety Scale will be used to measure depression and anxiety in both patients and healthy controls. |
| healthy controls | Active comparator | Diagnostic Test: nerve conduction study50 Healthy volunteers will be included in the control group of the study. Routine nerve conduction studies on both lower limbs as well as H-reflex, F-wave and SSEP will be performed on both patients and controls. Arabic versions of the Beck depression inventory and Taylor's Manifest Anxiety Scale (TMAS) will be used to measure depression and anxiety in both patients and healthy controls. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients suffering from chronic low back pain for more than 12 Weeks.
Key exclusion criteria (3 listed)
- Patients who are suspected of suffering from any autoimmune, rheumatological disorders that could explain the pain that they experienced will be excluded from the study.
- Patients who are suffering from any disease that could affect the results and interpretation of the parameters of the H-reflex, F-wave or SSEP, including polyneuropathy and radiculopathy.
- Patients who are suffering from any Structural Spinal cause of pain will be excluded by relative investigations.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nerve conduction studyRoutine nerve conduction study on both lower limbs as well as F- wave , Hoffman reflex and somatosensory evoked potential. | Diagnostic test | healthy controls, patients with chronic low back pain |
Primary outcome
Determine hoffman reflex latency in patient with chronic low back pain
Time frame: 8 months
Hoffman reflex latency will be measures in patient with chronic low back pain to assess spinal excitability
Determine F wave latency in patient with chronic low back pain
Time frame: 8 months
F wave latency will be measured in patient with chronic low back pain to assess spinal excitability
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2022.
- Background: PubMed 26487293Meucci RD, Fassa AG, Faria NM. Prevalence of chronic low back pain: systematic review. Rev Saude Publica. 2015;49:1. doi: 10.1590/S0034-8910.2015049005874. Epub 2015 Oct 20.
- Background: PubMed 31557238Knikou M, Murray LM. Repeated transspinal stimulation decreases soleus H-reflex excitability and restores spinal inhibition in human spinal cord injury. PLoS One. 2019 Sep 26;14(9):e0223135. doi: 10.1371/journal.pone.0223135. eCollection 2019.
- Background: PubMed 15850987Valat JP. Factors involved in progression to chronicity of mechanical low back pain. Joint Bone Spine. 2005 May;72(3):193-5. doi: 10.1016/j.jbspin.2004.07.010. No abstract available.
- 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.
Gharib F Mohamed, Professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nerve conduction study in people with Chronic Low-back Pain, run by Sohag University at 1 site in Egypt.
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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 23 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mahmoud K Khalaf, Resident (01099783232, mahmoud011176@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine hoffman reflex latency in patient with chronic low back pain (time frame: 8 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05402904, which also lists 3 linked publications.
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 23 Jun 2022.