Cervical RadiculopathyNCT03888573
Stretching Versus Traction in Patients With Cervical Radiculopathy.
A study testing Stretching protocol in people with Cervical Radiculopathy, run by Cairo University.
Trial summary
The purpose of the study is to compare the effects of traction decompression and neck muscle stretching on the magnitude of Flexor Carpi Radialis H-Reflex(HR), Neck Disability Index (NDI), and Visual Analogue Scale (VAS) pain scores 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?
- Stretching protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 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 should have C5-C6 and C6-C7 paramedian disc protrusion manifested by unilateral symptoms in C6-C7 roots dermatome and myotomes of the upper extremities.
- They were diagnosed as cervical disc protrusion (C5- C7) for at least three months.
- All patients should have a second grade of disc bulge (2-3mm) which was detected from T2 axial view of MRI.
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, osteoporosis.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Which is Better to Decompress the Nerve Roots in Cervical Radiculopathy: Stretching or Traction From Foraminal Opening Position
The purpose of the study is to compare the effects of traction decompression and neck muscle stretching on the magnitude of Flexor Carpi Radialis H-Reflex(HR), Neck Disability Index (NDI), and Visual Analogue Scale (VAS) pain scores in patients with cervical radiculopathy.
Read the detailed description
Cervical traction has long been used to relieve compression of nerve roots caused by intervertebral discs. Yet, there is lack of knowledge that compares the effect of traction decompression with neck muscles stretching in patients with cervical radiculopathy
- Conditions
- Cervical Radiculopathy
- Being tested
- Stretching protocol
- Keywords
- Stretching, Traction Decompression
- Medical subject headings
- Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stretching protocolOther
Also called Traction using The Triton decompression system
Patients within Stretch Group will receive stretching protocols to the cervical musculature at the side of symptoms. Traction Group will be treated with traction from 15-degree flexion, 30-degree lateral bending, and 15-degree rotation toward the painful side.
| Study group | Role | What they receive |
|---|---|---|
| Stretch | Active comparator | Patients within Stretch Group will receive stretching protocols to the cervical musculature at the side of symptoms. Receives: Other: Stretching protocol |
| Traction | Active comparator | Patients within Traction Group will be treated with traction from 15-degree flexion, 30-degree lateral bending, and 15-degree rotation toward the painful side. Receives: Other: Stretching protocol |
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 the four FCR-HR traces will be measured and averaged for each patient
Measured: change from Baseline after 6-week of treament
Secondary outcomes (2)
The Visual Analogue Scale Pain Scores(VAS)
A 10-cm VAS was used for assessing pain intensity. It is a line whose ends are labeled as the extremes of pain; no pain and very extreme pain. The line is marked at intervals 1 cm each without any label. Patients will be simply asked to indicate which point along the line that best represents the intensity of perceived pain. The distance from the "no pain" end to the mark made by the patient will be measured as the patient's pain intensity score.
Measured: Change from Baseline after 6-week of treament
The Neck Disability Index (NDI)
The NDI will be measured on a 6-point scale from 0 (no disability) to 5 (full disability). The numeric response for each item will be summed for a score varying from 0 to 50. The NDI consists of 10 sections, each section the total possible score is 5, if the first statement is marked; the section score = 0, if the last statement is marked it = 5. The patients will choose the best choice that reflect his current state. If all ten sections are completed the score is calculated by dividing the obtained score on the total number of scores e.g. if the score recorded by the patients was (40) so the NDI=(40/50)x100=80%
Measured: Change from Baseline after 6-week of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 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
- Patients will be randomly assigned into two groups; A and B. Patients within Group (A) will receive stretching protocols to the cervical musculature at the side of symptoms. Group (B) will be treated with traction from 15-degree flexion, 30-degree lateral bending, and 15-degree rotation toward the painful side.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 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 Hafez 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.Salam Mohamed Elhafez, Prof., Study director, Professor and Head of Department of Biomechanics, Faculty of Physical Therapy, Cairo University, Egypt.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03888573
- Sponsor's protocol ID
- nerve root decompression
- Status last verified
- Mar 2019
- First submitted
- 20 Mar 2019
- Last updated
- 26 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Caridi JM, Pumberger M, Hughes AP. Cervical radiculopathy: a review. HSS J. 2011 Oct;7(3):265-72. doi: 10.1007/s11420-011-9218-z. Epub 2011 Sep 9.
PubMed 23024624Graham N, Gross A, Goldsmith CH, Klaber Moffett J, Haines T, Burnie SJ, Peloso PM. Mechanical traction for neck pain with or without radiculopathy. Cochrane Database Syst Rev. 2008 Jul 16;2008(3):CD006408. doi: 10.1002/14651858.CD006408.pub2.
PubMed 18646151
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Which is Better to Decompress the Nerve Roots in Cervical Radiculopathy: Stretching or Traction From Foraminal Opening Position
- ClinicalTrials.gov ID
- NCT03888573
- Acronym / sponsor ID
- nerve root decompression
- Conditions
- Cervical Radiculopathy
- Keywords
- Stretching, Traction Decompression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 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
- 25 Mar 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 compare the effects of traction decompression and neck muscle stretching on the magnitude of Flexor Carpi Radialis H-Reflex(HR), Neck Disability Index (NDI), and Visual Analogue Scale (VAS) pain scores in patients with cervical radiculopathy.
Detailed description
Cervical traction has long been used to relieve compression of nerve roots caused by intervertebral discs. Yet, there is lack of knowledge that compares the effect of traction decompression with neck muscles stretching in patients with cervical radiculopathy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients will be randomly assigned into two groups; A and B. Patients within Group (A) will receive stretching protocols to the cervical musculature at the side of symptoms. Group (B) will be treated with traction from 15-degree flexion, 30-degree lateral bending, and 15-degree rotation toward the painful side.
| Arm | Type | Receives |
|---|---|---|
| Stretch | Active comparator | Other: Stretching protocolPatients within Stretch Group will receive stretching protocols to the cervical musculature at the side of symptoms. |
| Traction | Active comparator | Other: Stretching protocolPatients within Traction Group will be treated with traction from 15-degree flexion, 30-degree lateral bending, and 15-degree rotation toward the painful side. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients should have C5-C6 and C6-C7 paramedian disc protrusion manifested by unilateral symptoms in C6-C7 roots dermatome and myotomes of the upper extremities.
- They were diagnosed as cervical disc protrusion (C5- C7) for at least three months.
- All patients should have a second grade of disc bulge (2-3mm) which was detected from T2 axial view of MRI.
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, osteoporosis.
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 protocolAlso: Traction using The Triton decompression systemPatients within Stretch Group will receive stretching protocols to the cervical musculature at the side of symptoms. Traction Group will be treated with traction from 15-degree flexion, 30-degree lateral bending, and 15-degree rotation toward the painful side. | Other | Stretch, Traction |
Primary outcome
The Flexor Carpi radialis H-reflex
Time frame: change from Baseline after 6-week of treament
The peak-to-peak amplitudes of the four FCR-HR traces will be measured and averaged for each patient
2 secondary outcomes
The Visual Analogue Scale Pain Scores(VAS)
Time frame: Change from Baseline after 6-week of treament
The Neck Disability Index (NDI)
Time frame: Change from Baseline after 6-week of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2019.
- Background: PubMed 23024624Caridi JM, Pumberger M, Hughes AP. Cervical radiculopathy: a review. HSS J. 2011 Oct;7(3):265-72. doi: 10.1007/s11420-011-9218-z. Epub 2011 Sep 9.
- Background: PubMed 18646151Graham N, Gross A, Goldsmith CH, Klaber Moffett J, Haines T, Burnie SJ, Peloso PM. Mechanical traction for neck pain with or without radiculopathy. Cochrane Database Syst Rev. 2008 Jul 16;2008(3):CD006408. doi: 10.1002/14651858.CD006408.pub2.
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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.
Samiha Hafez 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.
Salam Mohamed Elhafez, Prof. study director
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 Stretching protocol 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 3 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 26 Mar 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 Farag Hanafy, Lecturer (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: change from Baseline after 6-week of treament). 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 NCT03888573, 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 26 Mar 2019.