- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03015493
Effectiveness of Cervical Traction and Neural Mobilization in Patients With Cervical Radiculopathy
Cervical Traction Combined With Neural Mobilization for Patients With Cervical Radiculopathy: A Randomized Controlled Trial.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Neural mobilization and traction
Patients in this group are treated with neural mobilization techniques combined with cervical traction
|
Neural mobilization techniques combined with cervical traction for the cervical nerve roots
|
Experimental: Traction group
Patients in this group are treated with cervical traction
|
Traction techniques for the cervical spine
|
No Intervention: Control group
Patients in this group comprise the control group and are not treated with any intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Neck Disability Index
Time Frame: Change from baseline after 4 weeks
|
Change from baseline after 4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Numeric Pain Rating Scale
Time Frame: Change from baseline after 4 weeks
|
Change from baseline after 4 weeks
|
Patient-Specific Functional Scale
Time Frame: Change from baseline after 4 weeks
|
Change from baseline after 4 weeks
|
Grip strength measurement using a dynamometer
Time Frame: Change from baseline after 4 weeks
|
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
|
Change from baseline after 4 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Chritos Savva, PhD, European University Cyprus
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHR7
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cervical Radiculopathy
-
Riphah International UniversityRecruitingCervical Radiculopathy | CervicalPakistan
-
Cairo UniversityCompletedCervical Radiculopathy | Disc Herniation | Cervical Radiculopathy at C5 Nerve Root | Cervical Radiculopathy at C6 Nerve Root | Cervical Radiculopathy at C7 Nerve RootEgypt
-
William Beaumont HospitalsCamber Spine TechnologiesTerminatedCervical Radiculopathy | Cervical Disc DiseaseUnited States
-
Gazi UniversityRecruitingCervical Radiculopathy | Cervical Radicular Pain | Cervical Radiculitis | Cervical Root SyndromeTurkey
-
Valérie SchuermansRecruitingCervical Disc Disease | Cervical Fusion | Fusion of Spine | Cervical Spondylosis | Cervical Disc Herniation | Myelopathy Cervical | Cervical Disc Degeneration | Radiculopathy, Cervical | Myelopathy, Compressive | Radiculopathy, Cervical Region | Radiculopathy; in Spondylosis | Radiculopathy; in Intervertebral... and other conditionsNetherlands
-
Marmara UniversityNot yet recruiting
-
Linkoeping UniversityRecruitingCervical RadiculopathySweden
-
Oslo University HospitalActive, not recruiting
-
Cairo UniversityUnknownCervical Radiculopathy
-
Isra UniversityUnknown
Clinical Trials on Neural mobilization combined with traction
-
University of LahoreRecruiting
-
Riphah International UniversityCompleted
-
University of PeradeniyaNot yet recruiting
-
Shifa Tameer-e-Millat UniversityRecruitingNeck Pain | Blood PressurePakistan
-
Isra UniversityUnknown
-
Riphah International UniversityCompletedLumbar RadiculopathyPakistan
-
Cairo UniversityCompleted
-
Isra UniversityUnknown
-
Riphah International UniversityRecruitingLumbar RadiculopathyPakistan