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Neurophysiological Assessment of Spinal Excitability in Chronic Low Back Pain

Primary Purpose

Chronic Low-back Pain

Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
nerve conduction study
Sponsored by
Sohag University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Chronic Low-back Pain

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • patients suffering from chronic low back pain for more than 12 Weeks.

Exclusion Criteria:

  1. 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.
  2. 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.
  3. Patients who are suffering from any Structural Spinal cause of pain will be excluded by relative investigations.

Sites / Locations

  • Sohag University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

patients with chronic low back pain

healthy controls

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Full Information

First Posted
May 15, 2022
Last Updated
June 16, 2022
Sponsor
Sohag University
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1. Study Identification

Unique Protocol Identification Number
NCT05402904
Brief Title
Neurophysiological Assessment of Spinal Excitability in Chronic Low Back Pain
Official Title
Neurophysiological Assessment of Spinal Excitability in Chronic Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 2022 (Anticipated)
Primary Completion Date
February 2023 (Anticipated)
Study Completion Date
February 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sohag University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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 . 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low-back Pain

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
patients with chronic low back pain
Arm Type
Active Comparator
Arm Description
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.
Arm Title
healthy controls
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
nerve conduction study
Intervention Description
Routine nerve conduction study on both lower limbs as well as F- wave , Hoffman reflex and somatosensory evoked potential.
Primary Outcome Measure Information:
Title
Determine hoffman reflex latency in patient with chronic low back pain
Description
Hoffman reflex latency will be measures in patient with chronic low back pain to assess spinal excitability
Time Frame
8 months
Title
Determine F wave latency in patient with chronic low back pain
Description
F wave latency will be measured in patient with chronic low back pain to assess spinal excitability
Time Frame
8 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: patients suffering from chronic low back pain for more than 12 Weeks. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mahmoud K Khalaf, Resident
Phone
01099783232
Email
mahmoud011176@med.sohag.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Gharib F Mohamed, Professor
Facility Information:
Facility Name
Sohag University Hospital
City
Sohag
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Osama R Elsherif, Professor

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
26487293
Citation
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.
Results Reference
background
PubMed Identifier
31557238
Citation
Knikou 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.
Results Reference
background
PubMed Identifier
15850987
Citation
Valat 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.
Results Reference
background

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Neurophysiological Assessment of Spinal Excitability in Chronic Low Back Pain

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