Effectiveness of Cervical Traction and Neural Mobilization in Patients With Cervical Radiculopathy
Primary Purpose
Cervical Radiculopathy
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Neural mobilization combined with traction
Traction
Sponsored by
About this trial
This is an interventional treatment trial for Cervical Radiculopathy focused on measuring Neck pain, Neurodynamics, Spinal manipulative therapy
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Neural mobilization and traction
Traction group
Control group
Arm Description
Patients in this group are treated with neural mobilization techniques combined with cervical traction
Patients in this group are treated with cervical traction
Patients in this group comprise the control group and are not treated with any intervention
Outcomes
Primary Outcome Measures
Neck Disability Index
Secondary Outcome Measures
Numeric Pain Rating Scale
Patient-Specific Functional Scale
Grip strength measurement using a dynamometer
Measurement of cervical spine active range of motion using a universal goniometer
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03015493
Brief Title
Effectiveness of Cervical Traction and Neural Mobilization in Patients With Cervical Radiculopathy
Official Title
Cervical Traction Combined With Neural Mobilization for Patients With Cervical Radiculopathy: A Randomized Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Unknown status
Study Start Date
May 2016 (undefined)
Primary Completion Date
February 2017 (Anticipated)
Study Completion Date
February 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Christos Savva
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Radiculopathy
Keywords
Neck pain, Neurodynamics, Spinal manipulative therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Neural mobilization and traction
Arm Type
Experimental
Arm Description
Patients in this group are treated with neural mobilization techniques combined with cervical traction
Arm Title
Traction group
Arm Type
Experimental
Arm Description
Patients in this group are treated with cervical traction
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Patients in this group comprise the control group and are not treated with any intervention
Intervention Type
Other
Intervention Name(s)
Neural mobilization combined with traction
Intervention Description
Neural mobilization techniques combined with cervical traction for the cervical nerve roots
Intervention Type
Other
Intervention Name(s)
Traction
Intervention Description
Traction techniques for the cervical spine
Primary Outcome Measure Information:
Title
Neck Disability Index
Time Frame
Change from baseline after 4 weeks
Secondary Outcome Measure Information:
Title
Numeric Pain Rating Scale
Time Frame
Change from baseline after 4 weeks
Title
Patient-Specific Functional Scale
Time Frame
Change from baseline after 4 weeks
Title
Grip strength measurement using a dynamometer
Time Frame
Change from baseline after 4 weeks
Title
Measurement of cervical spine active range of motion using a universal goniometer
Time Frame
Change from baseline after 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
71 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chritos Savva, PhD
Organizational Affiliation
European University Cyprus
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Undecided
Citations:
PubMed Identifier
19465371
Citation
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. Erratum In: Phys Ther. 2009 Nov;89(11):1254-5. Phys Ther. 2010 May;90(5):825.
Results Reference
result
Learn more about this trial
Effectiveness of Cervical Traction and Neural Mobilization in Patients With Cervical Radiculopathy
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