Cervical Lordosis RehabilitationNCT05547997
The Efficacy of Cervical Lordosis Rehabilitation for Nerve Root Function and Pain in Cervical Spondylotic Radiculopathy
A study testing Stretching exercises and Two way traction in people with Cervical Lordosis Rehabilitation, run by Cairo University at 1 site in Egypt.
Trial summary
To test the hypothesis that improvement of cervical lordosis (CL) in cervical spondylotic radiculopathy (CSR) will improve clinical features in a population suffering from CSR. Thirty chronic lower CSR patients with CL < 25° will be included. Read more about this study
- Who is it for?
- Ages 40 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Cervical Lordosis Rehabilitation
- What is being tested?
- Stretching exercises and Two way traction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2020to 1 Mar 2022
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Unilateral radiculopathy due to spondylotic changes of the lower cervical spine
- Absolute rotatory angle is less than 20°
- side to side amplitude differences of 50% or more in dermatomal somatosensory evoked potentials measurement
Who cannot join
- Central spinal canal stenosis
- Rheumatoid arthritis
- Vestibulobasilar insufficiency
- Osteoporosis
- Inability to tolerate the cervical extension position
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy of Cervical Lordosis Rehabilitation for Nerve Root Function and Pain in Cervical Spondylotic Radiculopathy: A Randomized Trial With 2-year Follow-up
To test the hypothesis that improvement of cervical lordosis (CL) in cervical spondylotic radiculopathy (CSR) will improve clinical features in a population suffering from CSR. Thirty chronic lower CSR patients with CL < 25° will be included. Patients will be assigned randomly into two equal groups, study and control . Both groups will receive neck stretching and exercises and infrared; additionally the study group will receive cervical extension traction. Treatments will be applied 3 time per week for 10 weeks after which groups will be followed for 3-months and 2-years. Amplitude of dermatomal somatosensory evoked potentials (DSSEPS), Cervical lordosis, and pain scales (NRS) will be measured.
Read the detailed description
Previous studies testing the effects of 3-point bending types of cervical traction, have not clarified exactly what impact the sagittal cervical curve correction has on nerve root function and pain responses associated with improving an abnormal cervical lordosis in cervical spondylotic patients. The present randomized controlled trial will be undertaken to investigate the neurophysiological and pain response outcomes of 3-point bending (2-way) traction compared to standard care in patient cases with lower cervical spine CSR, chronic pain, and with a verified hypo-lordosis of the cervical spine. The primary hypothesis of this study will be that cervical lordosis restoration will have short- and long-term effects on DSSEPs and pain outcomes in CSR patients.
- Conditions
- Cervical Lordosis Rehabilitation
- Being tested
- Stretching exercises, Two way traction
- Keywords
- Cervical spine, Lordosis, Dermatomal, Traction
- Medical subject headings
- Lordosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stretching exercisesOther
Exercises will be performed in the following order: 1) stretching towards lateral flexion for the upper part of the trapezius; 2) ipsilateral flexion and rotation for the scalene; 3) and flexion for the extensor muscles. Each maneuver will be held for 30 seconds as this is an optimum time to not create alteration in the evoked protentional. Each stretch will be repeated 3 times
Two way tractionOther
During the traction, the head halter will be fixed posteriorly to cause slight distraction, retraction, and slight extension and at the same time a front anterior strap had weight will be applied over a pulley that allows transverse traction load to be applied to the apex of the participants cervical curve alteration. Weights will start at 15 lbs. (6.8 Kg) on the anterior strap and will increase over consecutive visits to patient tolerance or a maximum of 35 lbs. (15.9 Kg).
| Study group | Role | What they receive |
|---|---|---|
| two way traction | Experimental | The study group will receive 3-point bending cervical extension traction following the protocol of Harrison et al. The duration of each session will starte at approximately three minutes and increased one minute per session until reaching the goal of 20 minutes per session Receives: Other: Stretching exercises; Other: Two way traction |
| traditional treatment | Active comparator | Stretching exercises: Patients will perform the stretching program 3 times a week; with a single session taking about 10 minutes to perform. Receives: Other: Stretching exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Change in amplitude of dermatomal somatosensory evoked potentials
In all dermatomes, two complete recording runs will be undertaken during each session, with averages of 250-1,200 cortical responses from scalp surface recording electrodes (C3'-C4' in a 10-20 electrode configuration) of the contralateral scalp to the C6, C7, and C8 dermatomes being stimulated
Measured: will be measured at four intervals ;before treatment, after 10 weeks of treatment, at follow up of 3 months and at follow up of 2 years
Secondary outcomes (1)
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 four intervals ;before treatment, after 10 weeks of treatment, at follow up of 3 months and at follow up of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2022
- Study start1 Jan 2020
- Primary completion1 Jan 2022
- Study completion1 Mar 2022
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
- Parallel Assignment A prospective, double blinded, parallel-group, randomized clinical trial will be conducted at one of our university's research departments,
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 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 Moustafa, Professor, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05547997
- Sponsor's protocol ID
- Cairo-20-18-4
- Status last verified
- Sep 2022
- First submitted
- 16 Sep 2022
- Last updated
- 21 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 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Cervical Lordosis Rehabilitation for Nerve Root Function and Pain in Cervical Spondylotic Radiculopathy: A Randomized Trial With 2-year Follow-up
- ClinicalTrials.gov ID
- NCT05547997
- Acronym / sponsor ID
- Cairo-20-18-4
- Conditions
- Cervical Lordosis Rehabilitation
- Keywords
- Cervical spine, Lordosis, Dermatomal, Traction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 21 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.
To test the hypothesis that improvement of cervical lordosis (CL) in cervical spondylotic radiculopathy (CSR) will improve clinical features in a population suffering from CSR. Thirty chronic lower CSR patients with CL < 25° will be included. Patients will be assigned randomly into two equal groups, study and control . Both groups will receive neck stretching and exercises and infrared; additionally the study group will receive cervical extension traction. Treatments will be applied 3 time per week for 10 weeks after which groups will be followed for 3-months and 2-years. Amplitude of dermatomal somatosensory evoked potentials (DSSEPS), Cervical lordosis, and pain scales (NRS) will be measured.
Detailed description
Previous studies testing the effects of 3-point bending types of cervical traction, have not clarified exactly what impact the sagittal cervical curve correction has on nerve root function and pain responses associated with improving an abnormal cervical lordosis in cervical spondylotic patients. The present randomized controlled trial will be undertaken to investigate the neurophysiological and pain response outcomes of 3-point bending (2-way) traction compared to standard care in patient cases with lower cervical spine CSR, chronic pain, and with a verified hypo-lordosis of the cervical spine. The primary hypothesis of this study will be that cervical lordosis restoration will have short- and long-term effects on DSSEPs and pain outcomes in CSR patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Assignment A prospective, double blinded, parallel-group, randomized clinical trial will be conducted at one of our university's research departments,
| Arm | Type | Receives |
|---|---|---|
| two way traction | Experimental | Other: Stretching exercises, Other: Two way tractionThe study group will receive 3-point bending cervical extension traction following the protocol of Harrison et al. The duration of each session will starte at approximately three minutes and increased one minute per session until reaching the goal of 20 minutes per session |
| traditional treatment | Active comparator | Other: Stretching exercisesStretching exercises: Patients will perform the stretching program 3 times a week; with a single session taking about 10 minutes to perform. |
Who may qualify
- Ages
- 40 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Unilateral radiculopathy due to spondylotic changes of the lower cervical spine
- Absolute rotatory angle is less than 20°
- side to side amplitude differences of 50% or more in dermatomal somatosensory evoked potentials measurement
Key exclusion criteria (5 listed)
- Central spinal canal stenosis
- Rheumatoid arthritis
- Vestibulobasilar insufficiency
- Osteoporosis
- Inability to tolerate the cervical extension position
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 |
|---|---|---|
| Stretching exercisesExercises will be performed in the following order: 1) stretching towards lateral flexion for the upper part of the trapezius; 2) ipsilateral flexion and rotation for the scalene; 3) and flexion for the extensor muscles. Each maneuver will be held for 30 seconds as this is an optimum time to not create alteration in the evoked protentional. Each stretch will be repeated 3 times | Other | traditional treatment, two way traction |
| Two way tractionDuring the traction, the head halter will be fixed posteriorly to cause slight distraction, retraction, and slight extension and at the same time a front anterior strap had weight will be applied over a pulley that allows transverse traction load to be applied to the apex of the participants cervical curve alteration. Weights will start at 15 lbs. (6.8 Kg) on the anterior strap and will increase over consecutive visits to patient tolerance or a maximum of 35 lbs. (15.9 Kg). | Other | two way traction |
Primary outcome
The Change in amplitude of dermatomal somatosensory evoked potentials
Time frame: will be measured at four intervals ;before treatment, after 10 weeks of treatment, at follow up of 3 months and at follow up of 2 years
In all dermatomes, two complete recording runs will be undertaken during each session, with averages of 250-1,200 cortical responses from scalp surface recording electrodes (C3'-C4' in a 10-20 electrode configuration) of the contralateral scalp to the C6, C7, and C8 dermatomes being stimulated
1 secondary outcome
The change in pain intensity
Time frame: will be measured at four intervals ;before treatment, after 10 weeks of treatment, at follow up of 3 months and at follow up of 2 years
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 21 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 Moustafa, Professor principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stretching exercises and Two way traction 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 3 inclusion and 5 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 21 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 amplitude of dermatomal somatosensory evoked potentials (time frame: will be measured at four intervals ;before treatment, after 10 weeks of treatment, at follow up of 3 months and at follow up of 2 years). 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 21 Sep 2022.