Cervical RadiculopathyNCT03898739
What is the Preferred Angle of Traction to Decompress Cervical Nerve Roots?
A study testing Cervical Traction from different angles in people with Cervical Radiculopathy, run by Cairo University.
Trial summary
The purpose of the study is to investigate the effect of different angles of decompression on the Flexor Carpi Radialis (FCR) H-Reflex in patients with cervical radiculopathy Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Cervical Radiculopathy
- What is being tested?
- Cervical Traction from different angles
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2019to 1 Sep 2019
- 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 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients will be included in the study if they have C5-C6 and C6-C7 paramedian disc protrusion manifested by unilateral symptoms in C6-C7 roots dermatome and myotomes of the upper extremities, second grade of disc bulge (2-3mm) which was detected from T2 axial view of MRI, and diagnosed as cervical disc protrusion (C5- C7) for at least three months.
Who cannot join
- Patients will be excluded from the study if they have upper cervical spine disc pathology, cord compression and upper motor neuron symptoms, curvature abnormalities of the neck including reversed curve (kyphotic) and deformities, cervical rib syndrome, double crush syndrome, diabetic neuropathy, text neck, short neck (churchill neck), marked facet joint, neuro-central joint arthropathic pathology, osteoporotic patients.
Trial locations and contacts
No sites are listed yet.
About this study
The purpose of the study is to investigate the effect of different angles of decompression on the Flexor Carpi Radialis (FCR) H-Reflex in patients with cervical radiculopathy
Read the detailed description
Cervical traction has long been defined as a distracting force that separate the cervical segments and relieve nerve roots compression. Yet, there is lack of knowledge that reports the effects of different traction decompression angles and determines the proper angle of pull among different angles of decompression system
- Conditions
- Cervical Radiculopathy
- Being tested
- Cervical Traction from different angles
- Keywords
- Traction, Decompression angles
- Medical subject headings
- Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervical Traction from different anglesOther
Intermittent traction will be applied, maximum force will be 16 kg, minimum force will be 12 kg, traction cycle of each minute consists of 20 seconds static traction at the maximum force then released down to the minimum force for 20 seconds then repeated for 20 seconds static traction. Traction session time will be 15 minutes, and the traction force will be increased progressively with speed (50%) of increment of force
| Study group | Role | What they receive |
|---|---|---|
| traction therapy from neutral position | Active comparator | Patients in this group will receive traction decompression from neutral neck position with rope angle (0°) Receives: Other: Cervical Traction from different angles |
| traction therapy from lateral bending | Active comparator | patients will undergo traction decompression from (30°) lateral bending of the neck toward the non-affected side Receives: Other: Cervical Traction from different angles |
| traction from flexion with lateral bending and rotation | Active comparator | patients will be treated with traction decompression from (15°) neck flexion, (30°) lateral bending toward non- affected side and (15°) rotation to the affected side. Receives: Other: Cervical Traction from different angles |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Flexor Carpi radialis H-reflex
The peak-to-peak amplitudes of four FCR-HR traces will be measured and averaged for each patient
Measured: Changes from Baseline to 6-weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2019
- Study start1 Apr 2019 (estimated)
- Primary completion1 Aug 2019 (estimated)
- Study completion1 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cervical RadiculopathyStudies 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
- One independent variable with many levels.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abeer Farag Hanafy, Cairo University
- Investigators
- Samiha H Hassan, Prof., Study chair, Professor of Physical Therapy for Neurology, Department of Physical Therapy for Neuromuscular Disorder and its Surgery, Faculty of Physical Therapy, Cairo University.Shaymaa M Abdelmeged, PhD, Study director, Lecturer at Department of Physical Therapy for Neuromuscular Disorder and its Surgery, Faculty of Physical Therapy, Cairo University.Salam M Elhafez, Prof., Study chair, Professor and Head of Department of Biomechanics, Faculty of Physical Therapy, Cairo University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03898739
- Sponsor's protocol ID
- Traction decompression angle
- Status last verified
- Mar 2019
- First submitted
- 30 Mar 2019
- Last updated
- 2 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Khan RR, Awan WA, Rashid S, Masood T. A randomized controlled trial of intermittent Cervical Traction in sitting Vs. Supine position for the management of Cervical Radiculopathy. Pak J Med Sci. 2017 Nov-Dec;33(6):1333-1338. doi: 10.12669/pjms.336.13851.
PubMed 29492054Liu J, Ebraheim NA, Sanford CG Jr, Patil V, Elsamaloty H, Treuhaft K, Farrell S. Quantitative changes in the cervical neural foramen resulting from axial traction: in vivo imaging study. Spine J. 2008 Jul-Aug;8(4):619-23. doi: 10.1016/j.spinee.2007.04.016. Epub 2007 Jun 21.
PubMed 17697801
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What is the Preferred Angle of Traction to Decompress Cervical Nerve Roots?
- ClinicalTrials.gov ID
- NCT03898739
- Acronym / sponsor ID
- Traction decompression angle
- Conditions
- Cervical Radiculopathy
- Keywords
- Traction, Decompression angles
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Apr 2019 (estimated)
- Primary completion
- 1 Aug 2019 (estimated)
- Study completion
- 1 Sep 2019 (estimated)
- First posted
- 2 Apr 2019 (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.
The purpose of the study is to investigate the effect of different angles of decompression on the Flexor Carpi Radialis (FCR) H-Reflex in patients with cervical radiculopathy
Detailed description
Cervical traction has long been defined as a distracting force that separate the cervical segments and relieve nerve roots compression. Yet, there is lack of knowledge that reports the effects of different traction decompression angles and determines the proper angle of pull among different angles of decompression system
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- One independent variable with many levels.
| Arm | Type | Receives |
|---|---|---|
| traction therapy from neutral position | Active comparator | Other: Cervical Traction from different anglesPatients in this group will receive traction decompression from neutral neck position with rope angle (0°) |
| traction therapy from lateral bending | Active comparator | Other: Cervical Traction from different anglespatients will undergo traction decompression from (30°) lateral bending of the neck toward the non-affected side |
| traction from flexion with lateral bending and rotation | Active comparator | Other: Cervical Traction from different anglespatients will be treated with traction decompression from (15°) neck flexion, (30°) lateral bending toward non- affected side and (15°) rotation to the affected side. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients will be included in the study if they have C5-C6 and C6-C7 paramedian disc protrusion manifested by unilateral symptoms in C6-C7 roots dermatome and myotomes of the upper extremities, second grade of disc bulge (2-3mm) which was detected from T2 axial view of MRI, and diagnosed as cervical disc protrusion (C5- C7) for at least three months.
Key exclusion criteria (1 listed)
- Patients will be excluded from the study if they have upper cervical spine disc pathology, cord compression and upper motor neuron symptoms, curvature abnormalities of the neck including reversed curve (kyphotic) and deformities, cervical rib syndrome, double crush syndrome, diabetic neuropathy, text neck, short neck (churchill neck), marked facet joint, neuro-central joint arthropathic pathology, osteoporotic patients.
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 |
|---|---|---|
| Cervical Traction from different anglesIntermittent traction will be applied, maximum force will be 16 kg, minimum force will be 12 kg, traction cycle of each minute consists of 20 seconds static traction at the maximum force then released down to the minimum force for 20 seconds then repeated for 20 seconds static traction. Traction session time will be 15 minutes, and the traction force will be increased progressively with speed (50%) of increment of force | Other | traction from flexion with lateral bending and rotation, traction therapy from lateral bending, traction therapy from neutral position |
Primary outcome
The Flexor Carpi radialis H-reflex
Time frame: Changes from Baseline to 6-weeks after treatment
The peak-to-peak amplitudes of four FCR-HR traces will be measured and averaged for each patient
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2019.
- Background: PubMed 29492054Khan RR, Awan WA, Rashid S, Masood T. A randomized controlled trial of intermittent Cervical Traction in sitting Vs. Supine position for the management of Cervical Radiculopathy. Pak J Med Sci. 2017 Nov-Dec;33(6):1333-1338. doi: 10.12669/pjms.336.13851.
- Background: PubMed 17697801Liu J, Ebraheim NA, Sanford CG Jr, Patil V, Elsamaloty H, Treuhaft K, Farrell S. Quantitative changes in the cervical neural foramen resulting from axial traction: in vivo imaging study. Spine J. 2008 Jul-Aug;8(4):619-23. doi: 10.1016/j.spinee.2007.04.016. Epub 2007 Jun 21.
Related trials for Cervical Radiculopathy
Recruiting
Ultrasound-Guided Electrical Dry Needling for Chronic Cervical Radiculopathy
Cervical Radiculopathy
Not yet recruitingObservational study
Correlation Between Forward Head Posture and Executive Functions in Cervical Radiculopathy
Cervical Radiculopathy, Forward Head Posture
Recruiting
Myo-Electrical and Nerve Root Function Response to Focused Extracorpeal Shock Wave in Cervical Radiculopathy
Cervical Radiculopathy
Not yet recruiting
Endoscopic Posterior Cervical Foraminotomy Versus Anterior Cervical Discectomy and Fusion for Cervical Radiculopathy
Cervical Disc Herniation, Cervical Foraminal Stenosis
RecruitingObservational study
Cervical Spinal Cord Signal Abnormalities in Patients With Cervical Radicular Pain
Cervical Radiculopathy, Cervical Myelomalacia
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.
Samiha H Hassan, Prof. study chair
Professor of Physical Therapy for Neurology, Department of Physical Therapy for Neuromuscular Disorder and its Surgery, Faculty of Physical Therapy, Cairo University.
Shaymaa M Abdelmeged, PhD study director
Lecturer at Department of Physical Therapy for Neuromuscular Disorder and its Surgery, Faculty of Physical Therapy, Cairo University.
Salam M Elhafez, Prof. study chair
Professor and Head of Department of Biomechanics, Faculty of Physical Therapy, Cairo University, Egypt
Questions about this trial
What is this clinical trial studying?
A study testing Cervical Traction from different angles in people with Cervical Radiculopathy, run by Cairo University.
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 1 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 2 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
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 Abeer F Hanafy, PhD (01063044443, abeerfarag22@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Flexor Carpi radialis H-reflex (time frame: Changes from Baseline to 6-weeks after treatment). 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 NCT03898739, which also lists 2 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 2 Apr 2019.