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CTRI Number  CTRI/2024/09/074496 [Registered on: 27/09/2024] Trial Registered Prospectively
Last Modified On: 24/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of effectiveness of mulligan technique versus mckenzie mobilization in cervical radiculopathy patients using neck disability index 
Scientific Title of Study   A comparative study to find out the effectiveness of mulligan versus mckenzie mobilization in cervical radiculopathy  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Manish Kumar Sah 
Designation  Master of Physiotherapy Student  
Affiliation  Burdwan Institute of Medical and Life Sciences  
Address  Exercise therapy lab, Department of Physiotherapy, Burdwan Institute of Medical and Life Sciences, University Campus, Golapbag, University Road Bardhaman

Barddhaman
WEST BENGAL
713104
India 
Phone  7003786769  
Fax    
Email  sahmanishkumar7@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr MS Anwar 
Designation  Principal  
Affiliation  Burdwan Institute of Medical and Life Sciences  
Address  Exercise therapy lab, Department of Physiotherapy, Burdwan Institute of Medical and Life Sciences, University Campus, Golapbag, University Road Bardhaman

Barddhaman
WEST BENGAL
713104
India 
Phone  9732445289  
Fax    
Email  anwarshahzada@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Rajnee Mishra 
Designation  Assistant Professor  
Affiliation  Burdwan Institute of Medical and Life Sciences  
Address  Exercise therapy lab, Department of Physiotherapy, Burdwan Institute of Medical and Life Sciences, University Campus, Golapbag, University Road Bardhaman

Barddhaman
WEST BENGAL
713104
India 
Phone  8697568628  
Fax    
Email  rajnee08mishra@gmail.com  
 
Source of Monetary or Material Support  
Room number 2,Exercise therapy lab, Department of Physiotherapy, Burdwan Institute of Medical and Life Sciences, University Campus, Golapbag, University Road, Bardhaman, West Bengal,PIN Code 713104, India  
 
Primary Sponsor  
Name  Manish Kumar Sah  
Address  Exercise therapy lab, Department of Physiotherapy, Burdwan Institute of Medical and Life Sciences, University Campus, Golapbag, University Road Bardhaman  
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Manish Kumar Sah   Burdwan Institute of Medical and Life Sciences   Exercise therapy lab, Department of Physiotherapy, Burdwan Institute of Medical and Life Sciences, University Campus, Golapbag, University Road Bardhaman
Barddhaman
WEST BENGAL 
7003786769

sahmanishkumar7@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee of Burdwan Institute of Medical and Life Sciences, Bardhaman, India  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M501||Cervical disc disorder with radiculopathy,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Mulligan Mobilization technique  Exercise in this group consists of functional SNAG/cervical MWMs, Natural apophyseal glides (NAGs), Sustained natural apophyseal glide (SNAGs) with help of mulligan belt. These exercises will be done 4 days in a week up to 4 weeks. 
Comparator Agent  McKenzie mobilization technique.  Exercise in this group consists of Retraction mobilization, Retraction extension with bilateral movement, and rotation mobilization. These exercises will be done 4 days in a week up to 4 weeks 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Patient having primary complain of radicular neck pain.
Pain intensity greater than 2 and less than 10 on NPRS.
Duration of illness two weeks including pain and stiffness.
Pain aggravated by movement. 
 
ExclusionCriteria 
Details  Infective condition of spine.
Autoimmune disorders.
Malignancy.
Any history of spine surgery.
Spinal deformity.
Osteoporosis.
Neck pain due to trauma.
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Alternation 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Neck disability index (NDI)  1st day of Assessment and after 4 weeks of treatment 
 
Secondary Outcome  
Outcome  TimePoints 
NUMERICAL PAIN RATING SCALE  1st day of treatment and after 4 weeks of treatment 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   14/10/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="7"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
Cervical radiculopathy is a condition of neck pain disorder. Neck pain is most common issue that can cause significant pain and disability. (1) The main cause of pain in cervical radiculopathy is inflammation. (2) It is estimated that 30-50% of the population affected in every year. Almost two of every three persons will experience neck pain at a certain time during their life time. Male and female are affected from cervical radiculopathy. Annual incidence has been reported to be 107.3 per 100,000 for men and 63.5 per 100,000 for women affected with cervical radiculopathy. (3) Cervical radiculopathy is a dysfunction of a nerve root in the cervical spine resulting in producing radicular symptom such as pain, paraesthesia, weakness, numb-ness in the upper extremity. Radiculopathy is differentiated from radicular pain, where radiculopathy is a neurological state in which conduction is limited or blocked along a spinal nerve or its. Cervical radiculopathy is believed to result from various mechanisms causing cervical nerve root irritation and a wide variety of symptoms distal to the irritation site. The causes of cervical radiculopathy include cervical stenosis, spinal degenerative changes, and cervical disc herniation, which can cause nerve root compression and/or irritation. (4) Commonly in cervical radiculopathy 70 to 75 percent of cases is foramina encroachment of the spinal nerve due to a combination of factors, including decreased disc height and degenerative changes of the intervertebral joints anteriorly and zygapophyseal joints posteriorly seen.
RATIONALE OF STUDY Cervical radiculopathy is a clinical condition which is present with pain from neck to whole upper limb or both upper limb. (9) Cervical radiculopathy is a specific lesion affecting the cervical nerve roots in which neck pain is accompanied by upper limb pain and possibly neurological symptoms and signs. (10) The nerve root is either irritated by bony osteophytes at the zygapophyseal or uncovertebral joints that are acquired secondary to cervical spondylosis or by a cervical disc herniation. Cervical radiculopathy will mostly classified as derangement. The postural correction and correction of derangement of cervical spine will be more helpful during treating the patients. Correction of derangement done by different types of mobilization and manipulation techniques. Mulligan mobilization have been found effective in reducing pain, disability and improving range of motion in patients with cervical radiculopathy. Working concept of Mulligan mobilization is ‘positional fault theory’. It helps to correct any micro-malalignment present in the joint surfaces so, pain can be decreased. It helps to increase the affected ranges. (11) McKenzie mobilization widely used as a classification system for the diagnosis and treatment of a variety of musculoskeletal conditions, including lower back, neck, and extremity pain. (12) McKenzie originally defined centralization as “a situation in which pain arising from the spine and felt laterally from the midline or distally is reduced and transferred to a more central or near midline position when certain movements are performed.” McKenzie mobilization have ability to centralize or decrease the patient’s referred or radicular symptoms through a series of repeated movements. The concept of repeated motions and centralization have been shown to be effective in treating radicular symptoms associated with the cervical spine, evidence is inconclusive for the use of specific, repeated motions for treating cervical radiculopathy.(13) This self-management aspect is very crucial for enabling individuals to apply techniques as needed in their daily lives to reduce dependency on healthcare professionals. Mulligan mobilization and McKenzie mobilization these two mobilization will take for treating patients with cervical radiculopathy. There are few evidences documented in the literature regarding the effectiveness of Mulligan mobilization McKenzie mobilization. The present study will be conducted to find out the efficacy of both the techniques over each other.
 OBJECTIVE OF RESEARCH 1. To evaluate the effectiveness of Mulligan Mobilization technique to reduce pain and disability in patients with cervical radiculopathy. 2. To evaluate the effectiveness of McKenzie Mobilization technique to reduce pain and disability in Patients with cervical radiculopathy. 3. To compare the effectiveness between Mulligan Mobilization and McKenzie Mobilization technique to reducing pain and disability in patients with cervical radiculopathy.
RESEARCH HYPOTHESIS NULL HYPOTHESIS (H0): There will be no significant difference between the effectiveness of Mulligan Mobilization and McKenzie Mobilization in reducing pain and disability in patients with cervical radiculopathy. ALTERNATIVE HYPOTHESIS (H1): There will be significant difference between the effectiveness of Mulligan Mobilization and McKenzie Mobilization in reducing pain and disability in patients with cervical radiculopathy.
STUDY TECHNIQUE 30 patients will be made as part of the study after selection based on inclusion and exclusion criteria, following signing of the informed consent will be conveniently selected for this study and they will be randomly allocated into two groups i.e. GROUP A and GROUP B, each group will be having 15 patients. GROUP A: In this group patients will be treated with Mulligan Mobilization technique. Exercise in this group consists of functional SNAG/cervical MWMs, Natural apophyseal glides (NAGs), Sustained natural apophyseal glide (SNAGs) with help of mulligan belt. These exercises will be done 4 days in a week up to 4 weeks. GROUP B: In this group patients will be treated with McKenzie mobilization technique. Exercise in this group consists of Retraction mobilization, Retraction extension with bilateral movement, and rotation mobilization. These exercises will be done 4 days in a week up to 4 weeks. 

 
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