Cervical RadiculopathyNCT03015493
Effectiveness of Cervical Traction and Neural Mobilization in Patients With Cervical Radiculopathy
A study testing Neural mobilization combined with traction and Traction in people with Cervical Radiculopathy, run by Christos Savva.
Trial summary
The purpose of the study is to examine the effects of cervical traction with or without the addition of neural mobilization, in patients with cervical radiculopathy Read more about this study
- Who is it for?
- Ages 22 to 71 years
- Conditions the study is for
- Cervical Radiculopathy
- What is being tested?
- Neural mobilization combined with traction and Traction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- May 2016to Feb 2017
- 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 22 to 71 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unilateral sensory and motor deficits including sharp pain, muscle weakness and numbness in the upper arm
- A positive result in a minimum three of four tests (Spurling's test, Distraction test, Upper Limb Neurodynamic Test 1 and ipsilateral cervical rotation of less than 60) of a clinical prediction rule. This clinical prediction rule has demonstrated 94% specificity (95% = 0.88 to 1.00), 24% sensitivity (95% = 0.05 to 0.43) and a positive likelihood ratio of 6.1 (95% = 2.0 to 18.6) when 3 of 4 items were positive
Who cannot join
- A current history of cervical myelopathy or signs of upper motor neuron disease
- Bilateral CR or other musculoskeletal conditions in the affected limb.
- Receive of any prescription or over-the-counter analgesia or anti-inflammatory medication during the prior two weeks
About this study
Official title: Cervical Traction Combined With Neural Mobilization for Patients With Cervical Radiculopathy: A Randomized Controlled Trial.
The purpose of the study is to examine the effects of cervical traction with or without the addition of neural mobilization, in patients with cervical radiculopathy
Read the detailed description
Background:Cervical radiculopathy (CR) is a disorder of the peripheral nervous system where the resulted cervical nerve root (CNR) pathology produces a chronic pain and disability. Based on some epidemiological findings, CR is a common clinical diagnosis since its annual incidence has been estimated to be 83 cases per 100,000, with an increased prevalence noted in the fifth decade of life. In addition, C6 and C7 nerve roots are most commonly involved in this disorder, mainly due to the high range of motion occurring between cervical vertebrae C5-C6 and C6-C7.
CR is caused by a disc herniation, or a space-occupying lesion that can result in CNR inflammation, impingement, or both. In normal situations, CNRs ensure the normal function of sensation, movement and motor coordination of the upper limb. Therefore, the development of CR can produce sensory and motor deficits in the involved limb, including pins and needles, numbness and muscle weakness, along with a neuropathic pain described as a burning or shooting pain. These symptoms lead patients to exhibit severe functional limitations such as difficulties to work, to sleep or to participate in hobbies. Studies on this topic identified several socioeconomic and psychological deficits, from lost work and wages to prolonged pain and impaired social functioning, leading patients with CR to express symptoms of anxiety and depression.
Treatment of CR has been the subject of debate between physiotherapists and researchers. Several non-operative treatment approaches have been advocated to reduce CR pain and their analgesic effect has been recognized in a number of randomized clinical trials with these in turn being analyzed in few systematic reviews. Based on these studies, patients with CR can benefit from a multimodal treatment approach including the application of postural education, cervical traction and manual therapy techniques (mobilization, thrust manipulation etc.) applied to the cervical spine. However the small number of these studies as well as their poor methodological quality due to the short-term follow ups, lack of patient's homogeneity, randomization or control group etc., raise several questions about the validity of research findings and therefore much more studies are necessary. Among manual therapy techniques that have been recommended to improve the patient's pain and functional limitations, neural mobilization (NM) has been advocated as an effective treatment option. NM introduced as an intervention for pain relief more than 25 years ago are techniques that involve a specific sequence of joint movements to mobilize the involved peripheral nerve in order to facilitate the reduced nerve gliding and reduced the increased neural mechanosensitivity.
The application of NM is common but since now little research attention has been given to support its usage in patients with CR. Recently, a case study and a randomized controlled study concluded that neural mobilization applied simultaneously with cervical traction can produce clinically meaningful improvements over a 4-week period, in terms of pain, disability, function, grip strength and cervical spine range of motion. However, both methodological designs did not allow determining whether NM provided these benefits. Thus, the purpose of the present study was to examine the effects of cervical traction with or without the addition of NM, in patients with CR.
- Conditions
- Cervical Radiculopathy
- Being tested
- Neural mobilization combined with traction, Traction
- Keywords
- Neck pain, Neurodynamics, Spinal manipulative therapy
- Medical subject headings
- Radiculopathy, Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neural mobilization combined with tractionOther
Neural mobilization techniques combined with cervical traction for the cervical nerve roots
TractionOther
Traction techniques for the cervical spine
| Study group | Role | What they receive |
|---|---|---|
| Neural mobilization and traction | Experimental | Patients in this group are treated with neural mobilization techniques combined with cervical traction Receives: Other: Neural mobilization combined with traction |
| Traction group | Experimental | Patients in this group are treated with cervical traction Receives: Other: Traction |
| Control group | No intervention | Patients in this group comprise the control group and are not treated with any intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neck Disability Index
Measured: Change from baseline after 4 weeks
Secondary outcomes (4)
Numeric Pain Rating Scale
Measured: Change from baseline after 4 weeks
Patient-Specific Functional Scale
Measured: Change from baseline after 4 weeks
Grip strength measurement using a dynamometer
Measured: Change from baseline after 4 weeks
Measurement of cervical spine active range of motion using a universal goniometer
Measured: Change from baseline after 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2017 (estimated)
- Study startMay 2016
- Primary completionFeb 2017 (estimated)
- Study completionFeb 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervical RadiculopathyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Christos Savva
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Christos Savva, European University Cyprus
- Investigators
- Chritos Savva, PhD, Principal investigator, European University Cyprus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03015493
- Sponsor's protocol ID
- CHR7
- Status last verified
- Jan 2017
- First submitted
- 6 Jan 2017
- Last updated
- 16 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: Undecided
Publications
Young IA, Michener LA, Cleland JA, Aguilera AJ, Snyder AR. Manual therapy, exercise, and traction for patients with cervical radiculopathy: a randomized clinical trial. Phys Ther. 2009 Jul;89(7):632-42. doi: 10.2522/ptj.20080283. Epub 2009 May 21.
PubMed 19465371
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cervical Traction Combined With Neural Mobilization for Patients With Cervical Radiculopathy: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT03015493
- Acronym / sponsor ID
- CHR7
- Conditions
- Cervical Radiculopathy
- Keywords
- Neck pain, Neurodynamics, Spinal manipulative therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Christos SavvaUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Feb 2017 (estimated)
- Study completion
- Feb 2017 (estimated)
- First posted
- 10 Jan 2017 (estimated)
- 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 examine the effects of cervical traction with or without the addition of neural mobilization, in patients with cervical radiculopathy
Detailed description
Background:Cervical radiculopathy (CR) is a disorder of the peripheral nervous system where the resulted cervical nerve root (CNR) pathology produces a chronic pain and disability. Based on some epidemiological findings, CR is a common clinical diagnosis since its annual incidence has been estimated to be 83 cases per 100,000, with an increased prevalence noted in the fifth decade of life. In addition, C6 and C7 nerve roots are most commonly involved in this disorder, mainly due to the high range of motion occurring between cervical vertebrae C5-C6 and C6-C7.
CR is caused by a disc herniation, or a space-occupying lesion that can result in CNR inflammation, impingement, or both. In normal situations, CNRs ensure the normal function of sensation, movement and motor coordination of the upper limb. Therefore, the development of CR can produce sensory and motor deficits in the involved limb, including pins and needles, numbness and muscle weakness, along with a neuropathic pain described as a burning or shooting pain. These symptoms lead patients to exhibit severe functional limitations such as difficulties to work, to sleep or to participate in hobbies. Studies on this topic identified several socioeconomic and psychological deficits, from lost work and wages to prolonged pain and impaired social functioning, leading patients with CR to express symptoms of anxiety and depression.
Treatment of CR has been the subject of debate between physiotherapists and researchers. Several non-operative treatment approaches have been advocated to reduce CR pain and their analgesic effect has been recognized in a number of randomized clinical trials with these in turn being analyzed in few systematic reviews. Based on these studies, patients with CR can benefit from a multimodal treatment approach including the application of postural education, cervical traction and manual therapy techniques (mobilization, thrust manipulation etc.) applied to the cervical spine. However the small number of these studies as well as their poor methodological quality due to the short-term follow ups, lack of patient's homogeneity, randomization or control group etc., raise several questions about the validity of research findings and therefore much more studies are necessary. Among manual therapy techniques that have been recommended to improve the patient's pain and functional limitations, neural mobilization (NM) has been advocated as an effective treatment option. NM introduced as an intervention for pain relief more than 25 years ago are techniques that involve a specific sequence of joint movements to mobilize the involved peripheral nerve in order to facilitate the reduced nerve gliding and reduced the increased neural mechanosensitivity.
The application of NM is common but since now little research attention has been given to support its usage in patients with CR. Recently, a case study and a randomized controlled study concluded that neural mobilization applied simultaneously with cervical traction can produce clinically meaningful improvements over a 4-week period, in terms of pain, disability, function, grip strength and cervical spine range of motion. However, both methodological designs did not allow determining whether NM provided these benefits. Thus, the purpose of the present study was to examine the effects of cervical traction with or without the addition of NM, in patients with CR.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Neural mobilization and traction | Experimental | Other: Neural mobilization combined with tractionPatients in this group are treated with neural mobilization techniques combined with cervical traction |
| Traction group | Experimental | Other: TractionPatients in this group are treated with cervical traction |
| Control group | No intervention | –Patients in this group comprise the control group and are not treated with any intervention |
Who may qualify
- Ages
- 22 to 71 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Unilateral sensory and motor deficits including sharp pain, muscle weakness and numbness in the upper arm
- A positive result in a minimum three of four tests (Spurling's test, Distraction test, Upper Limb Neurodynamic Test 1 and ipsilateral cervical rotation of less than 60) of a clinical prediction rule. This clinical prediction rule has demonstrated 94% specificity (95% = 0.88 to 1.00), 24% sensitivity (95% = 0.05 to 0.43) and a positive likelihood ratio of 6.1 (95% = 2.0 to 18.6) when 3 of 4 items were positive
Key exclusion criteria (3 listed)
- A current history of cervical myelopathy or signs of upper motor neuron disease
- Bilateral CR or other musculoskeletal conditions in the affected limb.
- Receive of any prescription or over-the-counter analgesia or anti-inflammatory medication during the prior two weeks
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 |
|---|---|---|
| Neural mobilization combined with tractionNeural mobilization techniques combined with cervical traction for the cervical nerve roots | Other | Neural mobilization and traction |
| TractionTraction techniques for the cervical spine | Other | Traction group |
Primary outcome
Neck Disability Index
Time frame: Change from baseline after 4 weeks
4 secondary outcomes
Numeric Pain Rating Scale
Time frame: Change from baseline after 4 weeks
Patient-Specific Functional Scale
Time frame: Change from baseline after 4 weeks
Grip strength measurement using a dynamometer
Time frame: Change from baseline after 4 weeks
Measurement of cervical spine active range of motion using a universal goniometer
Time frame: Change from baseline after 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2017.
- Results publication: PubMed 19465371Young IA, Michener LA, Cleland JA, Aguilera AJ, Snyder AR. Manual therapy, exercise, and traction for patients with cervical radiculopathy: a randomized clinical trial. Phys Ther. 2009 Jul;89(7):632-42. doi: 10.2522/ptj.20080283. Epub 2009 May 21.
- Individual participant dataSharing planned: Undecided. Undecided
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.
Chritos Savva, PhD principal investigator
European University Cyprus
Questions about this trial
What is this clinical trial studying?
A study testing Neural mobilization combined with traction and Traction in people with Cervical Radiculopathy, run by Christos Savva.
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 2 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: status not confirmed, as of the sponsor's last update on 16 Jan 2017. 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?
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?
Neck Disability Index (time frame: Change from baseline after 4 weeks). 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 NCT03015493, which also lists 1 linked publication.
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 16 Jan 2017.