Back to resultsMobilization With Movement vs. Neural Mobilization on Nerve Root Function in Patients With Cervical Radiculopathy
Primary Purpose
Disc Herniation, Cervical Radiculopathy, Cervical Radiculopathy at C5 Nerve Root
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Sustained natural apophyseal glides (SNAGS)
Neural mobilization
Traditional physical therapy
Sponsored by
About this trial
This is an interventional treatment trial for Disc Herniation
Eligibility Criteria
Inclusion Criteria: seventy patients with cervical disc (C 5-C 6 and/or C 6- C7) herniation with both sensory and motor nerve affections, referred from neurologist and confirmed diagnosis by MRI Both sexes. Age between 20-50 years. Patients with neck pain radiating down to the arm. Patients with positive findings for spurling test, Upper Limb Tension Test One (ULTTO), cervical distraction test and cervical rotation test towards the symptomatic side <60. BMI from 18 to 25 kg/cm2 Existed active trigger points within middle trapezius and/ or cervical region. Positive Pittsburgh sleep quality index' value >10, means moderate and/ or sever difficulty. Exclusion Criteria: Patients experiencing primary shoulder or upper extremity problem of local origin cardiovascular disorders and respiratory disorders, pathological conditions involving cervical spine like vertebro basilar insufficiency and canal stenosis osteophytes in cervical vertebrae Patients who were undergoing treatment for neck pain with other means of physiotherapy at the time of the study Cervical fractures, spinal surgery or other spinal pathologies (i.e. ankylosing spondylitis, spondylolisthesis) Peripheral nerve lesions like neurotmesis and axonotmesis.
Sites / Locations
- Ismailia medical complex
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Group A (SNAGs group)
Group B (Neural mobilization group)
Group C (traditional physical therapy)
Arm Description
Outcomes
Primary Outcome Measures
F-wave parameters
Evaluation of the spinal motoneuron excitability through the measurement of the F wave parameters
Somatosensory Evoked Potentials (SEPs) Latency and Amplitude
SEPs are the electrical signals generated by the nervous system in response to somatosensory stimuli. SEPs are read on the skull with electroencephalography (EEG)
Pain pressure threshold by Pressure algometer
An algometer will be used used to quantify pain intensity by pressure
Secondary Outcome Measures
Neck disability Index
Methods of assessment for such disability, especially those targeted at activities of daily living which are most affected by neck pain, questionnaire 10-item scaled entitled the Neck Disability Index (NDI)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05803954
Brief Title
Mobilization With Movement vs. Neural Mobilization on Nerve Root Function in Patients With Cervical Radiculopathy
Official Title
Mulligan Mobilization Technique Versus Neural Mobilization on Nerve Root Function in Patients With Cervical Radiculopathy: Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
March 31, 2023 (Actual)
Primary Completion Date
July 1, 2023 (Actual)
Study Completion Date
July 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will be conducted to compare the effect of sustained natural apophyseal glides (SNAGS) versus neural mobilization on clinical outcomes such as 1- nerve root function in the form of: (A) peak to peak amplitude; (B) latency; (C) F wave. 2- pain pressure threshold (PPT) and 3- Neck disability index (NDI) in patients with cervical disc (C5-C6 and/or C6-C7) herniation.
Seventy two patients from both gender with cervical disc (C 5-C 6 and/or C 6- C7) herniation with both sensory and motor nerve affections will be recruited for this study following referral from an experienced neurologist and confirmed diagnosis by MRI. The patients' age will range between 20-50 years, body mass index (BMI) from 18 to 25 kg/cm2.
The patients will be assigned randomly by permuted block to three equal groups; group (A) will receive SNAGS in addition to traditional therapy, group (B) will receive neural mobilization in addition to traditional therapy and group (C) will receive traditional therapy.
peak to peak amplitude, nerve latency and F wave will be measured by electromyography, , pressure pain threshold will be measured by commander algometer. Neck disability will be measured by Arabic neck disability index.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Disc Herniation, Cervical Radiculopathy, Cervical Radiculopathy at C5 Nerve Root, Cervical Radiculopathy at C6 Nerve Root, Cervical Radiculopathy at C7 Nerve Root
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A (SNAGs group)
Arm Type
Experimental
Arm Title
Group B (Neural mobilization group)
Arm Type
Experimental
Arm Title
Group C (traditional physical therapy)
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Sustained natural apophyseal glides (SNAGS)
Intervention Description
SNAGS will be applied with the patient sitting comfortably on a stool. The therapist stand behind the patient and the medial border of one thumb's distal phalanx is placed on the articular pillar on the chosen side of the suspected site of lesion. The thumb nail slope at approximately 45 degree (in the direction of the eyeball). SNAGS mulligan will be given by active movement followed by passive overpressure based on the movement restricted by frequency of treatment will be three sets of ten repetitions. SNAG the anteroposterior mobilization of the second cervical vertebrae is sustained for 10 to 30 s depending on response. A maximum of 6 repetitions will be given if there is a reduction in headache intensity at the time of the first application. A total of 20 oscillations (1 oscillation/1 second) will be given to each joint with a total duration of 15 minutes
Intervention Type
Other
Intervention Name(s)
Neural mobilization
Intervention Description
Neural mobilization will be applied with grade three neural mobilization and traditional therapy: Subjects will be placed in supine position and remained relaxed with the feet uncrossed. The patient will be slightly angled obliquely for easier access to the scapula. The therapist will be depressed the scapula with concomitant upper extremity joint positioning as per median nerve bias i.e., ULTT2 (shoulder abduction, elbow extension with forearm supination, wrist and fingers extended and ulnar deviated and thumb abduction). The wrist will be used as a tension factor and at the point where tension was felt by the therapist and perceived by the subject. Grade 3 oscillations were given rhythmically and slowly to each joint from proximal to distal. A total of 20 oscillations (1 oscillation/1 second) were given to each joint with a total duration of 15 minutes.
Intervention Type
Other
Intervention Name(s)
Traditional physical therapy
Intervention Description
traditional therapy will be applied in the form of stretching for bilateral upper and middle trapezius muscles and bilateral neck rotators and isometric strengthening exercises for neck rotators, extensors, side bending muscles. Exercise was repeated for ten repetitions per session. In addition to hot pack was placed over the neck and upper part of shoulders musculature. This was being applied for ten min, over middle trapezius trigger Point itself.
Primary Outcome Measure Information:
Title
F-wave parameters
Description
Evaluation of the spinal motoneuron excitability through the measurement of the F wave parameters
Time Frame
Change over the course of the study, from baseline to the end of treatment program at 4 weeks
Title
Somatosensory Evoked Potentials (SEPs) Latency and Amplitude
Description
SEPs are the electrical signals generated by the nervous system in response to somatosensory stimuli. SEPs are read on the skull with electroencephalography (EEG)
Time Frame
Change over the course of the study, from baseline to the end of treatment program at 4 weeks
Title
Pain pressure threshold by Pressure algometer
Description
An algometer will be used used to quantify pain intensity by pressure
Time Frame
Change over the course of the study, from baseline to the end of treatment program at 4 weeks
Secondary Outcome Measure Information:
Title
Neck disability Index
Description
Methods of assessment for such disability, especially those targeted at activities of daily living which are most affected by neck pain, questionnaire 10-item scaled entitled the Neck Disability Index (NDI)
Time Frame
Change over the course of the study, from baseline to the end of treatment program at 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
seventy patients with cervical disc (C 5-C 6 and/or C 6- C7) herniation with both sensory and motor nerve affections, referred from neurologist and confirmed diagnosis by MRI
Both sexes.
Age between 20-50 years.
Patients with neck pain radiating down to the arm.
Patients with positive findings for spurling test, Upper Limb Tension Test One (ULTTO), cervical distraction test and cervical rotation test towards the symptomatic side <60.
BMI from 18 to 25 kg/cm2
Existed active trigger points within middle trapezius and/ or cervical region.
Positive Pittsburgh sleep quality index' value >10, means moderate and/ or sever difficulty.
Exclusion Criteria:
Patients experiencing primary shoulder or upper extremity problem of local origin
cardiovascular disorders and respiratory disorders,
pathological conditions involving cervical spine like vertebro basilar insufficiency and canal stenosis
osteophytes in cervical vertebrae
Patients who were undergoing treatment for neck pain with other means of physiotherapy at the time of the study
Cervical fractures, spinal surgery or other spinal pathologies (i.e. ankylosing spondylitis, spondylolisthesis)
Peripheral nerve lesions like neurotmesis and axonotmesis.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amany I. Selem, BSc
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ismailia medical complex
City
Ismailia
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Mobilization With Movement vs. Neural Mobilization on Nerve Root Function in Patients With Cervical Radiculopathy
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