Low Back Pain, MechanicalNCT04759963
Impact of Epidural Anesthesia on Low Back Function
An observational study of Low Back Pain, Mechanical, run by South Valley University at 2 sites in Egypt.
Trial summary
Back pain is a common complication after the use of epidural anesthesia in obstetric and non-obstetric surgeries and occurs in 30-45% of cases (Brown, 2005). Certain psychological problems such as depression or unhappiness due to loss of employment may prolong the episode of low back pain (Miller, 2012). Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain, Mechanical
- How many people
- 38 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 May 2021to 26 Sep 2021
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: 45 women were enrolled in this study with a 20% rate loss of follow-up (i.e. we need at least 38 participants to complete the study). They were selected from the SVU Teaching Hospitals. The Participants were classified into 4 groups: - Group (A): This group included 6 women. They gave birth through a cesarean delivery using Midline approach epidural anesthesia, Group (B): This group included 13 women. They gave birth through a cesarean delivery using Midline approach spinal anesthesia Group (C): This group included 7 women. They gave birth through a cesarean delivery using general anesthesia. Group (D): This group included 12 women. who are the control group,
Who may be able to join
- All women gave birth through a cesarean delivery.
- Their ages will range from 18 to 35 years.
- All participants will have body mass index (BMI) not more than 30.
- All participants will be assessed after 6weeks postnatal.
- All participants will be able to continue all assessment procedures.
Who cannot join
- Women who delivered through vaginal delivery.
- Women who delivered through cesarean delivery but the used anesthetic technique was the paramedian approach of epidural anesthesia.
- Women who have any non-myofascial low back dysfunctions.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Faculty of Physical Therapy - SVU
Cairo, 11672
Faculty of physical therapy, South Valley University
Cairo, 11672
About this study
Official title: Impact of Obstetric Epidural Anesthesia on Mechanical Function of Low Back
Back pain is a common complication after the use of epidural anesthesia in obstetric and non-obstetric surgeries and occurs in 30-45% of cases (Brown, 2005). Certain psychological problems such as depression or unhappiness due to loss of employment may prolong the episode of low back pain (Miller, 2012). According to Egyptian Institution of Health Metrics and Evaluation (IHME), Low Back Pain is the first cause of disability in Egypt from 2007 to 2017.
So, this study will investigate if midline approach of obstetric epidural anaesthesia will be a relative risk for subacute low back mechanical functions as a new way to examine if this type of anaesthesia is involved in the presence of subacute negative effects on the mechanical function of low back or not (to resolve the controversy).
Read the detailed description
The lumbar (or lower back) region is made up of five vertebrae (L1-L5), sometimes including the sacrum. Stability of the spine is provided by the ligaments and muscles of the back and abdomen (Floyd and Thompson, 2008).
The primary biomechanical function of the spine is to provide structural support, to allow the body to move freely, and to protect the spinal cord and nerves. Muscles balance external loads to the spine, which supports the load and allows for the motion through its multilevel joint arrangement (Dreischarf et al., 2016).
Low back pain (LBP) is a common minor yet unpleasant complication after epidural anesthesia. Different mechanisms are suggested such as needle trauma and myotoxicity of local anesthetic (Louizos et al., 2005) and incidence of backache after epidural anaesthesia might be expected to be higher than that after spinal anaesthesia (Brown and Elman, 1961).
In most episodes of low back pain, a specific underlying cause is not identified or even looked for, with the pain believed to be due to mechanical problems such as muscle or joint strain (Casazza, 2012). Most cases are idiopathic but usually attributable to muscle strain or ligament injury; found in 65% to 70% of patients with mechanical chronic back pain (Cohen et al., 2008) while totally mechanical low back pain is reported as the cause in about 80% to 95% of patients with low back pain (Cohen et al., 2008) \& (Dixit, 2017).
Caesarean section is when a baby is born through an incision in the mother's abdomen and uterine wall. This requires effective anaesthesia which can be regional (epidural or spinal) or a general anaesthetic. With regional epidural anaesthesia, the anaesthetic is infused into the space around the mother's spinal column, whilst with regional spinal anaesthesia, the drug is injected as a single dose into the mother's spinal column. With the two types of regional anaesthesia, the mother is awake for the birth but numbed from the waist down while with general anaesthesia, the mother is unconscious for the birth with the anaesthetic affecting her whole body (Afolabi and Lesi, 2012).
The epidural needle can be placed using the midline or paramedian approach. In both cases, lidocaine 1% is infiltrated in the epidural needle insertion area.
In the midline approach technique, the needle is placed in the midline between 2 spine processes. In the paramedian approach technique, the needle is inserted 1 cm lateral and 1 cm caudal to the lower border of the upper spinous process.
The epidural needle in the medline approach is advanced through ligaments: supraspinous ligament, interspinous ligament, ligamentum flavum and into the target epidural space. Each ligament has different density and texture, which affects the feel of the needle and the resistance to insertion (Vaughan et al., 2013).
Some explanations for Low Back Dysfunction after Epidural Anaesthesia:
The incidence of back pain after epidural anesthesia is over 20% (Rose, 2012) \& (Saghafinia et al., 2009) \& (Muslu et al., 2009). It occurs rarely after spinal anesthesia (Schwabe and Hopf, 2001). This indicates that back pain may be associated with local trauma and nerve injury caused by the epidural needle, leading to aseptic periosteitis, tendonitis, ligamentous inflammation and/or osteochondritis, which result in lumbar pain (Kalso, 2013).
- Excessive elongation of spinal ligaments can cause micro-trauma of the ligament fibers and tears or ruptures occur. Also, the interspinous ligaments are the first structures damaged (excessive stretching) when the spine is hyperflexed (Adams et al., 1998).
- Degeneration and excessive stress on the thoracolumbar fascia may also cause micro-trauma, and resulting in tears. Thoracolumbar fascia may become damaged by over-stretching or excessive stress, potentially eliciting pain (Bogduk, 1983).
- Other contributing factors include needle trauma, surgical positioning, injection of saline or local anesthetic into the interspinous ligaments and development of a supraspinous hematoma (Covet et al., 1967), (Crawford, 1972).
- Excessive stretching of ligaments after relaxation of paraspinal muscles and localized trauma to the intervertebral disc has also been implicated in causing back pain (Agarwal and Kishore, 2009).
Visual analogue scale (VAS):
The visual analogue scale is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain." (Delgado et al., 2018).
Pressure algometry:
Pressure algometry has been described as a semi-objective method, or subjective measure and Pain Pressure Threshold (PPT) is a quantitative sensory test of tissue sensitivity, and it is defined as the minimal amount of pressure that produces pain, measured via a pressure algometer (Ylinen, 2007).
Inclinometers:
An inclinometer or tilt meter is an instrument for measuring angles of slope (or tilt), elevation or depression of an object or body segment with respect to gravity (Nielsen et al., 2011).
Oswestry Disability Index:
The Oswestry Disability Index (ODI) is a valid, reliable, and responsive condition-specific assessment tool that is suited for use in clinical practice. It is easy to administer and score, objectifies clients' complaints, and monitors effects of therapy (Vianin, 2008).
Isokinetic dynamometry:
The isokinetic dynamometer is a gold standard instrument for measuring muscle strength and is safe, valid, and reliable, based on the use of kinetic parameters that also include the angular measurement of a corporeal segment throughout the range of motion (Gonosova et al., 2018) \& (Habets et al., 2018) \& (Roth et al., 2017) \& (Guilhem et al., 2014).
Ultrasound Elastography:
Ultrasound elastography (EUS) is a recently developed ultrasound-based method, which allows the qualitative visual or quantitative measurements of the mechanical properties of tissue (Hall, 2003), (Garra, 2007) \& (Garra, 2011).
Myoton Pro Device:
A MyotonPRO (Myoton AS, Estonia) is a portable hand-held myotonometer that can assess muscle tone and soft tissue stiffness. According to prior research, the MyotonPRO is a reliable quantitative measurement for assessing the mechanical properties of muscles (Pruyn et al., 2016).
The MyotonPRO can differentiate the viscoelastic properties of a trigger point from a non-trigger point. Our findings support the reliability of this myotonometer. This affordable and portable tool can be used to objectively measure viscoelastic properties of trigger points (Roch et al., 2020).
- Conditions
- Low Back Pain, Mechanical
- Medical subject headings
- Low Back Pain
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 |
|---|---|---|
| Group A | follow up for 6 women who gave birth through a cesarean delivery with Midline approach epidural anesthesia. They will perform all assessment procedures: Visual analog scale (VAS) and Oswestry Disability Index (ODI). | |
| Group B | follow up for 13 women who gave birth through a cesarean delivery with Midline approach spinal anesthesia. They will perform all assessment procedures: Visual analog scale (VAS) and Oswestry Disability Index (ODI). | |
| Group C | follow up for 7 women who gave birth through a cesarean delivery with general anesthesia. They will perform all assessment procedures: Visual analog scale (VAS) and Oswestry Disability Index (ODI). | |
| Group D | follow up for 12 women who are the control group (who did not experience any pregnancy or anesthesia. They will perform all assessment procedures: Visual analog scale (VAS) and Oswestry Disability Index (ODI). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subacute Low Back Pain intensity
Subacute Low Back Pain intensity is assessed by Visual Analogue scale: Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between 0 "no pain" and 10 "worst pain."
Measured: assessment will be done at 6 weeks after the use of anaesthesia during Cesarean section
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2021
- Study start1 May 2021
- Primary completion30 Aug 2021
- Study completion26 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back Pain, MechanicalStudies 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
- Retrospective
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- South Valley University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Gamal Abouelyazeed Ali, South Valley University
- Investigators
- Mohamed GA Ali, Msc, Principal investigator, South Valley University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04759963
- Sponsor's protocol ID
- South Valley University
- Status last verified
- Sep 2021
- First submitted
- 23 Jan 2021
- Last updated
- 1 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Obstetric Epidural Anesthesia on Mechanical Function of Low Back
- ClinicalTrials.gov ID
- NCT04759963
- Acronym / sponsor ID
- South Valley University
- Conditions
- Low Back Pain, Mechanical
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- South Valley UniversityUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 30 Aug 2021 (actual)
- Study completion
- 26 Sep 2021 (actual)
- First posted
- 18 Feb 2021 (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.
Back pain is a common complication after the use of epidural anesthesia in obstetric and non-obstetric surgeries and occurs in 30-45% of cases (Brown, 2005). Certain psychological problems such as depression or unhappiness due to loss of employment may prolong the episode of low back pain (Miller, 2012). According to Egyptian Institution of Health Metrics and Evaluation (IHME), Low Back Pain is the first cause of disability in Egypt from 2007 to 2017.
So, this study will investigate if midline approach of obstetric epidural anaesthesia will be a relative risk for subacute low back mechanical functions as a new way to examine if this type of anaesthesia is involved in the presence of subacute negative effects on the mechanical function of low back or not (to resolve the controversy).
Detailed description
The lumbar (or lower back) region is made up of five vertebrae (L1-L5), sometimes including the sacrum. Stability of the spine is provided by the ligaments and muscles of the back and abdomen (Floyd and Thompson, 2008).
The primary biomechanical function of the spine is to provide structural support, to allow the body to move freely, and to protect the spinal cord and nerves. Muscles balance external loads to the spine, which supports the load and allows for the motion through its multilevel joint arrangement (Dreischarf et al., 2016).
Low back pain (LBP) is a common minor yet unpleasant complication after epidural anesthesia. Different mechanisms are suggested such as needle trauma and myotoxicity of local anesthetic (Louizos et al., 2005) and incidence of backache after epidural anaesthesia might be expected to be higher than that after spinal anaesthesia (Brown and Elman, 1961).
In most episodes of low back pain, a specific underlying cause is not identified or even looked for, with the pain believed to be due to mechanical problems such as muscle or joint strain (Casazza, 2012). Most cases are idiopathic but usually attributable to muscle strain or ligament injury; found in 65% to 70% of patients with mechanical chronic back pain (Cohen et al., 2008) while totally mechanical low back pain is reported as the cause in about 80% to 95% of patients with low back pain (Cohen et al., 2008) \& (Dixit, 2017).
Caesarean section is when a baby is born through an incision in the mother's abdomen and uterine wall. This requires effective anaesthesia which can be regional (epidural or spinal) or a general anaesthetic. With regional epidural anaesthesia, the anaesthetic is infused into the space around the mother's spinal column, whilst with regional spinal anaesthesia, the drug is injected as a single dose into the mother's spinal column. With the two types of regional anaesthesia, the mother is awake for the birth but numbed from the waist down while with general anaesthesia, the mother is unconscious for the birth with the anaesthetic affecting her whole body (Afolabi and Lesi, 2012).
The epidural needle can be placed using the midline or paramedian approach. In both cases, lidocaine 1% is infiltrated in the epidural needle insertion area.
In the midline approach technique, the needle is placed in the midline between 2 spine processes. In the paramedian approach technique, the needle is inserted 1 cm lateral and 1 cm caudal to the lower border of the upper spinous process.
The epidural needle in the medline approach is advanced through ligaments: supraspinous ligament, interspinous ligament, ligamentum flavum and into the target epidural space. Each ligament has different density and texture, which affects the feel of the needle and the resistance to insertion (Vaughan et al., 2013).
Some explanations for Low Back Dysfunction after Epidural Anaesthesia:
The incidence of back pain after epidural anesthesia is over 20% (Rose, 2012) \& (Saghafinia et al., 2009) \& (Muslu et al., 2009). It occurs rarely after spinal anesthesia (Schwabe and Hopf, 2001). This indicates that back pain may be associated with local trauma and nerve injury caused by the epidural needle, leading to aseptic periosteitis, tendonitis, ligamentous inflammation and/or osteochondritis, which result in lumbar pain (Kalso, 2013).
- Excessive elongation of spinal ligaments can cause micro-trauma of the ligament fibers and tears or ruptures occur. Also, the interspinous ligaments are the first structures damaged (excessive stretching) when the spine is hyperflexed (Adams et al., 1998).
- Degeneration and excessive stress on the thoracolumbar fascia may also cause micro-trauma, and resulting in tears. Thoracolumbar fascia may become damaged by over-stretching or excessive stress, potentially eliciting pain (Bogduk, 1983).
- Other contributing factors include needle trauma, surgical positioning, injection of saline or local anesthetic into the interspinous ligaments and development of a supraspinous hematoma (Covet et al., 1967), (Crawford, 1972).
- Excessive stretching of ligaments after relaxation of paraspinal muscles and localized trauma to the intervertebral disc has also been implicated in causing back pain (Agarwal and Kishore, 2009).
Visual analogue scale (VAS):
The visual analogue scale is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain." (Delgado et al., 2018).
Pressure algometry:
Pressure algometry has been described as a semi-objective method, or subjective measure and Pain Pressure Threshold (PPT) is a quantitative sensory test of tissue sensitivity, and it is defined as the minimal amount of pressure that produces pain, measured via a pressure algometer (Ylinen, 2007).
Inclinometers:
An inclinometer or tilt meter is an instrument for measuring angles of slope (or tilt), elevation or depression of an object or body segment with respect to gravity (Nielsen et al., 2011).
Oswestry Disability Index:
The Oswestry Disability Index (ODI) is a valid, reliable, and responsive condition-specific assessment tool that is suited for use in clinical practice. It is easy to administer and score, objectifies clients' complaints, and monitors effects of therapy (Vianin, 2008).
Isokinetic dynamometry:
The isokinetic dynamometer is a gold standard instrument for measuring muscle strength and is safe, valid, and reliable, based on the use of kinetic parameters that also include the angular measurement of a corporeal segment throughout the range of motion (Gonosova et al., 2018) \& (Habets et al., 2018) \& (Roth et al., 2017) \& (Guilhem et al., 2014).
Ultrasound Elastography:
Ultrasound elastography (EUS) is a recently developed ultrasound-based method, which allows the qualitative visual or quantitative measurements of the mechanical properties of tissue (Hall, 2003), (Garra, 2007) \& (Garra, 2011).
Myoton Pro Device:
A MyotonPRO (Myoton AS, Estonia) is a portable hand-held myotonometer that can assess muscle tone and soft tissue stiffness. According to prior research, the MyotonPRO is a reliable quantitative measurement for assessing the mechanical properties of muscles (Pruyn et al., 2016).
The MyotonPRO can differentiate the viscoelastic properties of a trigger point from a non-trigger point. Our findings support the reliability of this myotonometer. This affordable and portable tool can be used to objectively measure viscoelastic properties of trigger points (Roch et al., 2020).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A | – | –follow up for 6 women who gave birth through a cesarean delivery with Midline approach epidural anesthesia. They will perform all assessment procedures: Visual analog scale (VAS) and Oswestry Disability Index (ODI). |
| Group B | – | –follow up for 13 women who gave birth through a cesarean delivery with Midline approach spinal anesthesia. They will perform all assessment procedures: Visual analog scale (VAS) and Oswestry Disability Index (ODI). |
| Group C | – | –follow up for 7 women who gave birth through a cesarean delivery with general anesthesia. They will perform all assessment procedures: Visual analog scale (VAS) and Oswestry Disability Index (ODI). |
| Group D | – | –follow up for 12 women who are the control group (who did not experience any pregnancy or anesthesia. They will perform all assessment procedures: Visual analog scale (VAS) and Oswestry Disability Index (ODI). |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 45 women were enrolled in this study with a 20% rate loss of follow-up (i.e. we need at least 38 participants to complete the study). They were selected from the SVU Teaching Hospitals. The Participants were classified into 4 groups: - Group (A): This group included 6 women. They gave birth through a cesarean delivery using Midline approach epidural anesthesia, Group (B): This group included 13 women. They gave birth through a cesarean delivery using Midline approach spinal anesthesia Group (C): This group included 7 women. They gave birth through a cesarean delivery using general anesthesia. Group (D): This group included 12 women. who are the control group,
Key inclusion criteria (5 listed)
- All women gave birth through a cesarean delivery.
- Their ages will range from 18 to 35 years.
- All participants will have body mass index (BMI) not more than 30.
- All participants will be assessed after 6weeks postnatal.
- All participants will be able to continue all assessment procedures.
Key exclusion criteria (3 listed)
- Women who delivered through vaginal delivery.
- Women who delivered through cesarean delivery but the used anesthetic technique was the paramedian approach of epidural anesthesia.
- Women who have any non-myofascial low back dysfunctions.
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
Subacute Low Back Pain intensity
Time frame: assessment will be done at 6 weeks after the use of anaesthesia during Cesarean section
Subacute Low Back Pain intensity is assessed by Visual Analogue scale: Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between 0 "no pain" and 10 "worst pain."
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 1 Oct 2021.
- 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.
Mohamed GA Ali, Msc principal investigator
South Valley University
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 Low Back Pain, Mechanical, run by South Valley University at 2 sites 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 5 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: finished, as of the sponsor's last update on 1 Oct 2021. 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 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?
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?
Subacute Low Back Pain intensity (time frame: assessment will be done at 6 weeks after the use of anaesthesia during Cesarean section). 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 1 Oct 2021; AzTrials last refreshed its copy on 29 Oct 2026.