Cervical Lordosis RehabilitationNCT05553002
Does Improvement Towards a Normal Cervical Sagittal Configuration Aid in the Management of Lumbosacral Radiculopathy
A study testing Deneroll cervical extension traction and Traditional treatment in people with Cervical Lordosis Rehabilitation, run by Cairo University at 1 site in Egypt.
Trial summary
A randomized controlled study with six months follow-up will be conducted to investigate the effects of sagittal head posture correction on 3D spinal posture parameters, back and leg pain, disability, and S1 nerve root function in patients with chronic discogenic lumbosacral radiculopathy . Read more about this study
- Who is it for?
- Ages 40 to 55 years
- Conditions the study is for
- Cervical Lordosis Rehabilitation
- What is being tested?
- Deneroll cervical extension traction and Traditional treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2011to 12 Dec 2012
- 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 40 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Absolute rotatory angle less than 25° and greater than 0.
- Anterior head translation distance greater than 15mm
- Confirmed chronic unilateral lumbosacral radiculopathy associated with L5-S1 lumbar disc prolapse .
- Symptoms lasting longer than 3 months
Who cannot join
- Previous history of lumbosacral surgery.
- Metabolic system disorder.
- Peripheral neuropathy.
- History of upper motor neuron lesion.
- Spinal canal stenosis.
- Rheumatoid arthritis.
- Osteoporosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Improvement Towards a Normal Cervical Sagittal Configuration Aid in the Management of Lumbosacral Radiculopathy: A Randomized Controlled Trial
A randomized controlled study with six months follow-up will be conducted to investigate the effects of sagittal head posture correction on 3D spinal posture parameters, back and leg pain, disability, and S1 nerve root function in patients with chronic discogenic lumbosacral radiculopathy . Participants will include 80 patients between 40 and 55 years experiencing chronic discogenic lumbosacral radiculopathy with a definite hypolordotic cervical spine and forward head posture and will be randomly assigned a comparative treatment control group and a study group. Both groups will receive TENS therapy and hot packs, additionally, the study group will receive the Denneroll cervical traction orthotic.
Read the detailed description
Despite the fact that there is some evidence of a link between low back pain and head posture , there is limited experimental data to support a cause-and-effect relationship and interventional outcomes. Accordingly, a prospective, randomized, controlled study will be conducted at a research laboratory of our university to investigate if cervical curve restoration and forward head posture correction will have short and long term effects on three dimensional spinal posture parameters as well as lumbar radiculopathy management outcomes such as symptoms, disability, and neurophysiological findings .In this study we will use an orthotic cervical traction termed the Denneroll to help restore normal sagittal spinal configuration based on principles of 3-point bending traction methods. Interventions will be applied at a frequency of 3 times per week for 10 weeks and groups will be followed for an additional 6-months.
- Conditions
- Cervical Lordosis Rehabilitation
- Being tested
- Deneroll cervical extension traction, Traditional treatment
- Keywords
- lumbosacral radiculopathy, Disc herniation, Cervical lordosis
- Medical subject headings
- Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deneroll cervical extension tractionOther
Participants will lie flat on their back on the ground with their legs extended and arms by their sides. The denneroll will placed on the ground and positioned in the posterior aspect of the neck depending on the area to be addressed . The apex of the Denneroll orthotic will be placed in one of three regions based on lateral cervical radiographic displacements:
- In the upper cervical region (C2-C4) region.
- The apex of the Denneroll orthotic is placed in the mid-cervical region (C4-C6) region.
- The apex of the Denneroll orthotic is placed in the upper thoracic lower-cervical region (C6-T1) region.
Traditional treatmentOther
The participants will receive hot packs (15 minutes) and TENS therapy .During TENS application. Patients will be asked to adopt a prone position. The TENS therapy will be delivered at the lumbosacral region for 20 min. The frequency will set to 80 Hz and pulse width to 50 µs due to its analgesic effect . These conventional treatments will be repeated three times per week over the course of 10 weeks for 30 total sessions
| Study group | Role | What they receive |
|---|---|---|
| Deneroll cervical extension traction | Experimental | The study group will receive 3-point bending cervical extension traction following the protocol of Deed Harrison . The duration of each session will start at approximately three minutes and increased one minute per session until reaching the goal of 20 minutes per session Receives: Other: Deneroll cervical extension traction; Other: Traditional treatment |
| Traditional treatment | Active comparator | The participants will receive hot packs (15 minutes) and TENS therapy to control pain and eliminate the causal role of muscle spasms and/or tightness in changing the posture parameters. Receives: Other: Traditional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Change in cervical absolute rotatory angle
Cervical absolute rotatory angle is formed by two lines intersecting from the posterior body margins of C2-C7 and forward head distance
Measured: will be measured at three intervals :pretreatment, 10 weeks post treatment, and at six months of follow-up
The Change in anterior head translation
anterior head translation is measured as the horizontal displacement of the posterior superior body corner of C2 vertebra relative to a vertical line extending superiorly from the posterior inferior body corner of C7..
Measured: will be measured at three intervals :pretreatment, 10 weeks post treatment, and at six months of follow-up
Secondary outcomes (4)
The change in 3D spinal posture parameters
Rasterstereography sagittal plane parameters (lumbar angles, thoracic angles, and trunk inclination), the frontal plane parameters (trunk imbalance and lateral deviation) and the transversal plane parameters (vertebral surface rotation and pelvis torsion) will be selected to cover the posture profile in three planes
Measured: will be measured at three intervals :pretreatment, 10 weeks post treatment, and at six months of follow-up
The change in pain intensity
Measurement of pain will be performed by using a visual analogue scale (VAS). The subjects will be asked about the perception of pain using a 10-cm line with 0 (no pain) on one end and 10 (worst pain) on the other. subjects will be asked to place a mark along the line to denote their level of pain
Measured: will be measured at three intervals :pretreatment, 10 weeks post treatment, and at six months of follow-up
The change in disability level
Disability will be measured using the Oswestry Disability Index. The total score is transferred onto a scale ranging from 0 to 100, where 0 indicates no disability and 100 indicates worst possible disability
Measured: will be measured at three intervals :pretreatment, 10 weeks post treatment, and at six months of follow-up
The change in peak to peak amplitude of H reflex
The H-reflex (or Hoffmann's reflex) is a reaction of muscles after electrical stimulation of sensory fibers (Ia afferents stemming from muscle spindles) in their innervating nerves
Measured: will be measured at three intervals :pretreatment, 10 weeks post treatment, and at six months of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2022
- Study start1 May 2011
- Primary completion1 May 2012
- Study completion12 Dec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Lordosis RehabilitationStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A prospective, randomized, controlled study will be conducted at a research laboratory of our university. Participants will be randomly assigned to to either the treatment group or the control group
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ibrahim Moustafa, Cairo University
- Investigators
- Ibrahim M Moustafa, Professor, Principal investigator, University of Sharjah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05553002
- Sponsor's protocol ID
- Cairo-11-2-15
- Status last verified
- Sep 2022
- First submitted
- 21 Sep 2022
- Last updated
- 23 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Improvement Towards a Normal Cervical Sagittal Configuration Aid in the Management of Lumbosacral Radiculopathy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05553002
- Acronym / sponsor ID
- Cairo-11-2-15
- Conditions
- Cervical Lordosis Rehabilitation
- Keywords
- lumbosacral radiculopathy, Disc herniation, Cervical lordosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 May 2011 (actual)
- Primary completion
- 1 May 2012 (actual)
- Study completion
- 12 Dec 2012 (actual)
- First posted
- 23 Sep 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.
A randomized controlled study with six months follow-up will be conducted to investigate the effects of sagittal head posture correction on 3D spinal posture parameters, back and leg pain, disability, and S1 nerve root function in patients with chronic discogenic lumbosacral radiculopathy . Participants will include 80 patients between 40 and 55 years experiencing chronic discogenic lumbosacral radiculopathy with a definite hypolordotic cervical spine and forward head posture and will be randomly assigned a comparative treatment control group and a study group. Both groups will receive TENS therapy and hot packs, additionally, the study group will receive the Denneroll cervical traction orthotic.
Detailed description
Despite the fact that there is some evidence of a link between low back pain and head posture , there is limited experimental data to support a cause-and-effect relationship and interventional outcomes. Accordingly, a prospective, randomized, controlled study will be conducted at a research laboratory of our university to investigate if cervical curve restoration and forward head posture correction will have short and long term effects on three dimensional spinal posture parameters as well as lumbar radiculopathy management outcomes such as symptoms, disability, and neurophysiological findings .In this study we will use an orthotic cervical traction termed the Denneroll to help restore normal sagittal spinal configuration based on principles of 3-point bending traction methods. Interventions will be applied at a frequency of 3 times per week for 10 weeks and groups will be followed for an additional 6-months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A prospective, randomized, controlled study will be conducted at a research laboratory of our university. Participants will be randomly assigned to to either the treatment group or the control group
| Arm | Type | Receives |
|---|---|---|
| Deneroll cervical extension traction | Experimental | Other: Deneroll cervical extension traction, Other: Traditional treatmentThe study group will receive 3-point bending cervical extension traction following the protocol of Deed Harrison . The duration of each session will start at approximately three minutes and increased one minute per session until reaching the goal of 20 minutes per session |
| Traditional treatment | Active comparator | Other: Traditional treatmentThe participants will receive hot packs (15 minutes) and TENS therapy to control pain and eliminate the causal role of muscle spasms and/or tightness in changing the posture parameters. |
Who may qualify
- Ages
- 40 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Absolute rotatory angle less than 25° and greater than 0.
- Anterior head translation distance greater than 15mm
- Confirmed chronic unilateral lumbosacral radiculopathy associated with L5-S1 lumbar disc prolapse .
- Symptoms lasting longer than 3 months
Key exclusion criteria (7 listed)
- Previous history of lumbosacral surgery.
- Metabolic system disorder.
- Peripheral neuropathy.
- History of upper motor neuron lesion.
- Spinal canal stenosis.
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 |
|---|---|---|
| Deneroll cervical extension tractionParticipants will lie flat on their back on the ground with their legs extended and arms by their sides. The denneroll will placed on the ground and positioned in the posterior aspect of the neck depending on the area to be addressed . The apex of the Denneroll orthotic will be placed in one of three regions based on lateral cervical radiographic displacements: 1. In the upper cervical region (C2-C4) region. 2. The apex of the Denneroll orthotic is placed in the mid-cervical region (C4-C6) region. 3. The apex of the Denneroll orthotic is placed in the upper thoracic lower-cervical region (C6-T1) region. | Other | Deneroll cervical extension traction |
| Traditional treatmentThe participants will receive hot packs (15 minutes) and TENS therapy .During TENS application. Patients will be asked to adopt a prone position. The TENS therapy will be delivered at the lumbosacral region for 20 min. The frequency will set to 80 Hz and pulse width to 50 µs due to its analgesic effect . These conventional treatments will be repeated three times per week over the course of 10 weeks for 30 total sessions | Other | Deneroll cervical extension traction, Traditional treatment |
Primary outcome
The Change in cervical absolute rotatory angle
Time frame: will be measured at three intervals :pretreatment, 10 weeks post treatment, and at six months of follow-up
Cervical absolute rotatory angle is formed by two lines intersecting from the posterior body margins of C2-C7 and forward head distance
The Change in anterior head translation
Time frame: will be measured at three intervals :pretreatment, 10 weeks post treatment, and at six months of follow-up
anterior head translation is measured as the horizontal displacement of the posterior superior body corner of C2 vertebra relative to a vertical line extending superiorly from the posterior inferior body corner of C7..
4 secondary outcomes
The change in 3D spinal posture parameters
Time frame: will be measured at three intervals :pretreatment, 10 weeks post treatment, and at six months of follow-up
The change in pain intensity
Time frame: will be measured at three intervals :pretreatment, 10 weeks post treatment, and at six months of follow-up
The change in disability level
Time frame: will be measured at three intervals :pretreatment, 10 weeks post treatment, and at six months of follow-up
The change in peak to peak amplitude of H reflex
Time frame: will be measured at three intervals :pretreatment, 10 weeks post treatment, and at six months of follow-up
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 23 Sep 2022.
- Individual participant dataSharing planned: No
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.
Ibrahim M Moustafa, Professor principal investigator
University of Sharjah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deneroll cervical extension traction and Traditional treatment in people with Cervical Lordosis Rehabilitation, run by Cairo 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 4 inclusion and 7 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 23 Sep 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?
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 Change in cervical absolute rotatory angle (time frame: will be measured at three intervals :pretreatment, 10 weeks post treatment, and at six months of follow-up). 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?
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 Sep 2022.