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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

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 groups in NCT03015493
Study groupRoleWhat they receive
Neural mobilization and tractionExperimentalPatients in this group are treated with neural mobilization techniques combined with cervical traction
Receives: Other: Neural mobilization combined with traction
Traction groupExperimentalPatients in this group are treated with cervical traction
Receives: Other: Traction
Control groupNo interventionPatients 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.

  1. Neck Disability Index

    Measured: Change from baseline after 4 weeks

Secondary outcomes (4)
  1. Numeric Pain Rating Scale

    Measured: Change from baseline after 4 weeks

  2. Patient-Specific Functional Scale

    Measured: Change from baseline after 4 weeks

  3. Grip strength measurement using a dynamometer

    Measured: Change from baseline after 4 weeks

  4. 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.

  1. First posted10 Jan 2017 (estimated)
  2. Study startMay 2016
  3. Primary completionFeb 2017 (estimated)
  4. Study completionFeb 2017 (estimated)

Resources

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)
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

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.

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