- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06653543
Effect of Mulligan on Cervical Radiculopathy
Effect of Mulligan Mobilization With Arm Movement on Nerve Conduction Velocity in Patients With Unilateral Cervical Radiculopathy
The goal of this clinical trial is to investigate the effect of Mulligan mobilization with arm movement on nerve conduction velocity in patients with unilateral cervical radiculopathy. The main questions it aims to answer are :
- Is there a statistical significant effect of mobilization with arm movement on NCV velocity in treatment of cervical radiculopathy ?
- Is there a statistical significant effect of mobilization with arm movement on pain level in treatment of cervical radiculopathy ?
- Is there a statistical significant effect of mobilization with arm movement on cervical ROM in treatment of cervical radiculopathy ?
- Is there a statistical significant effect of mobilization with arm movement on neck disability level in treatment of cervical radiculopathy ?
The course of treatment involves 6 sessions over the course of 3 weeks participants will be divided into 2 groups : Control group : recieves only Conventional treatment Experimental group : recieves Conventional treatment and Mulligan mobilization with arm movement .
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
the aim of our study is to examine the effect of Mulligan mobilization with arm movement on cervical radiculopathy using nerve conduction studies , in addition to the original measures of previous studies (pain level, cervical ROM and neck disability scale) .
Delimitations :
Inclusion Criteria
Individuals will be enrolled into the study if they are :
- diagnosed with cervical radiculopathy .
- Age group between 20-60 years
- Unilateral radiating pain through the course of median nerve .
- Subject having positive upper limb tension test (ULTT 1)
- either gender male and female
- Subjects who can understand the instructions and are willing to participate in the study.
Exclusion Criteria .
- History of trauma, dislocation and subluxation of upper extremity
- Rheumatoid Arthritis
- Malignancy
- Spinal canal stenosis .
- Cervical instability/Spondylolisthesis
- VBI (Vertebral-Basillar Insufficiency)
- Referred pain in patients with cardiac ischemia
- Cervical or thoracic spine surgeries
- systemic causes like diabetic neuropathy.
- recent fracture or surgery in and around the shoulder
- carpal tunnel syndrome .
- thoracic outlet syndrome .
Outcome measure would include:
A) The primary outcome measure will be NCV velocity, for the median nerve (latency, amplitude, Duration , F-wave and nerve conduction velocity of motor nerve action potentials and sensory nerve action potentials (SNAPs)) .
B) Secondary outcome measures will include:
- Pain intensity, assessed using the Visual Analog Scale (VAS) .
- Functional disability, evaluated using the Neck Disability Index (NDI) .
- Cervical range of motion, measured using a CROM goniometer to assess flexion, extension, lateral flexion, and rotation.
- The course of treatment involves 6 sessions over the course of 3 weeks .
pre-treatment for both groups :
- affected nerve conduction velocity will be measured using nerve conduction study .
- neck disability level will be measured using neck disability index .
- cervical ROM measurement will be taken in all directions using CROM goniometer .
- pain will be assessed using Visual analog scale .
participants will be divided into 2 groups :
Group A- Control group:
During each session : only Conventional treatment will be provided , includes : hot pack for 10 minutes, active ranges of motion (AROMs) with 3 sets of 10 repetitions and isometrics for each movement repeated 20 times with the hold of 6 to 10 seconds in each repetition.
Group B- Experimental group- Mulligan mobilization group:
During each session :
- Conventional treatment will be provided .
- Mulligan mobilization will be applied in the form of : sustained passive accessory joint mobilization to a specific spinal vertebra level while simultaneously guiding the patient through an active, pain-free movement pattern involving the affected limb :
- Patient position : Sitting upright on chair
- Therapist position : Standing behind the patient .
- Hand placement : Approach the desired level of spinous process from medial aspect of the thumb of one hand, which may be reinforced by the index finger of the other hand.
- Mobilization Pure transverse glide is performed from affected to unaffected side. While the glide is sustained, patient performs the offending movements (flexion/abduction/horizontal adduction/horizontal abduction)
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Elgazar
- Phone Number: 201013863820
- Email: tawfiq.algazar_a010@pt.kfs.edu.eg
Study Locations
-
-
Kafr El-Sheikh
-
Kafr El-Sheikh Governorate, Kafr El-Sheikh, Egypt, 33516
- Recruiting
- Kafr El-Sheikh University
-
Contact:
- university
- Phone Number: 047 3109590
- Email: tawfiq.algazar_a010@pt.kfs.edu.eg
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
• diagnosed with cervical radiculopathy .
- Age group between 20-60 years
- Unilateral radiating pain through the course of median nerve .
- Subject having positive upper limb tension test (ULTT 1)
- either gender male and female
- Subjects who can understand the instructions and are willing to participate in the study.
Exclusion Criteria:
• History of trauma, dislocation and subluxation of upper extremity
- Rheumatoid Arthritis
- Malignancy
- Spinal canal stenosis .
- Cervical instability/Spondylolisthesis
- VBI (Vertebral-Basillar Insufficiency)
- Referred pain in patients with cardiac ischemia
- Cervical or thoracic spine surgeries .
- systemic causes like diabetic neuropathy .
- recent fracture or surgery in and around the shoulder .
- carpal tunnel syndrome .
- thoracic outlet syndrome .
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: mulligan group
20 participants recieving conventional therapy in addition to mulligan mobilization with arm movement
|
mulligan mobilization applied on cervical spine with arm movement
hot pack for 10 minutes, active ranges of motion (AROMs) with 3 sets of 10 repetitions and isometrics for each movement repeated 20 times with the hold of 6 to 10 seconds in each repetition
|
|
Sham Comparator: control group
control group that revieves only the conventional therapy
|
hot pack for 10 minutes, active ranges of motion (AROMs) with 3 sets of 10 repetitions and isometrics for each movement repeated 20 times with the hold of 6 to 10 seconds in each repetition
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
median nerve conduction study
Time Frame: 2 weeks
|
using nerve conduction studies to measure the median nerve (latency, amplitude, Duration , F-wave and nerve conduction velocity of motor nerve action potentials and sensory nerve action potentials ) .
|
2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
cervical range of motion
Time Frame: 2 weeks
|
using cervical CROM device to measure the cervical ROM in all 3 planes
|
2 weeks
|
|
pain
Time Frame: 2 weeks
|
using visual analogue scale for the pain intensity .. where no pain or discomfort(0) , while the severest pain (10) .. the more the pain , the more the points on the scale
|
2 weeks
|
|
neck disability level
Time Frame: 2 weeks
|
using neck disability index questionnaire consists of 10 items, where each item is scored on a scale of 0 to 5, with 0 indicating no disability and 5 indicating complete disability
|
2 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/005110
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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