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CTRI Number  CTRI/2024/04/065194 [Registered on: 04/04/2024] Trial Registered Prospectively
Last Modified On: 03/04/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of Exercises and Nerve Mobilization with neck Traction in Cervical Radiculopathy Patients 
Scientific Title of Study   Effect of McKenzie Exercises and Neural Mobilization Technique combined with Intermittent Cervical Traction in Patients with 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  Jyoti 
Designation  BPT Student 
Affiliation  Department of Physiotherapy Guru Jambheshwar University of Science and Technology, Hisar 
Address  Department of Physiotherapy Guru Jambheshwar University of Science and Technology, Hisar

Hisar
HARYANA
125001
India 
Phone  0  
Fax    
Email  jyoti200171710054@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Usha PT 
Designation  Assistant Professor 
Affiliation  Department of Physiotherapy Guru Jambheshwar University of Science and Technology, Hisar 
Address  Department of Physiotherapy Guru Jambheshwar University of Science and Technology, Hisar

Hisar
HARYANA
125001
India 
Phone  0  
Fax    
Email  ushasportsphysio@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Jyoti 
Designation  BPT Student 
Affiliation  Department of Physiotherapy Guru Jambheshwar University of Science and Technology, Hisar 
Address  Department of Physiotherapy Guru Jambheshwar University of Science and Technology, Hisar

Hisar
HARYANA
125001
India 
Phone  0  
Fax    
Email  jyoti200171710054@gmail.com  
 
Source of Monetary or Material Support  
Department of Physiotherapy Guru Jambheshwar University of Science and Technology, Hisar 
 
Primary Sponsor  
Name  Jyoti 
Address  Department of Physiotherapy Guru Jambheshwar University of Science and Technology, Hisar 
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 Usha PT  Department of Physiotherapy Guru Jambheshwar University, Hisar  OPD room no.4 Department of Physiotherapy Guru Jambheshwar University, Hisar
Hisar
HARYANA 
7056157540

jyoti200171710054@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee Department of Physiotherapy Guru Jambheshwar University of Science and Technology, Hisar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M472||Other spondylosis with radiculopathy,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  McKenzie Exercises with Intermittent Cervical Traction  McKenzie Exercises with Intermittent Cervical Traction will be given to patients with cervical radiculopathy for 4 days per week for 4 weeks. 
Comparator Agent  Neural Mobilization Technique with Intermittent Cervical Traction  Neural Mobilization Technique with Intermittent Cervical Traction will be given to patients with cervical radiculopathy for 4 days per week for 4 weeks. 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Subjects with Cervical radiculopathy for more than 6 months
Age 25-50 years
Both male and female
Positive Spurling’s test
 
 
ExclusionCriteria 
Details  History of any injury or surgery around neck and shoulders
History of any other musculoskeletal, neurological, cardiopulmonary or psychological disorders
Patients who are non-cooperative
Patients currently on steroidal medication prescribed for radiculopathy symptoms

 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Other 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Pain
Neck Disability 
The outcome measures will be assessed at baseline and after 4 weeks. 
 
Secondary Outcome  
Outcome  TimePoints 
Hand Grip
Cervical Proprioception 
The outcome measures will be assessed at baseline and after 4 weeks. 
 
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)   15/04/2024 
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="3"
Days="15" 
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 common condition characterized by pain, numbness, tingling and/or heaviness in arm as symptoms. The radiating pain is usually present  along the distribution of a cervical nerve root. The average annual incidence rate of cervical radiculopathy is 83 per 100000 of population, with an increased prevalence occurring in the 5th decade of life (Dhuriya et al., 2021). The most commonly affected level is C5-C6 with 86% of affected population and the C6-C7 level is the next most frequently affected site. The involvement of the 8th cervical nerve root by a herniated C7-T1 disc produces a significant weakness of the intrinsic musculature of the hand which results in significant loss of fine movements of hand (Mohamed Faisal et al., 2012). The muscle weakness produced in one segment of the affected upper limb, would contribute to a generalized muscle weakness and consequently reduced hand strength (Nair et al., 2017). One of the lesser known impact of cervical spondylosis is on cervical joint position sense. As cervical spondylosis is a degenerative condition it can adversely affect the proprioceptive mechanism that regulate the neck position and movement (Alahmari and Reddy, 2024). The most common treatment for cervical radiculopathy is mechanical traction which is used to decompress the nerve root by separating the cervical segments through long-axis traction (Sarfaraj, 2018). Neural mobilization and McKenzie techniques when given with mechanical traction have improved pain and disability but there effects on hand grip and cervical proprioception need to explored in patients with cervical radiculopathy. As, neural mobilization mobilizes nerve tissue which results in reduced intrinsic pressure of the neural tissue and can re-establish the neural biomechanics such as elasticity etc. (Mohammed et al., 2019). The McKenzie techniques are used for treatment of the postural, dysfunctional and derangement syndromes in neck region. They have been proven to be effective in pain, neck disability and cervical muscle endurance in cervical radiculopathy individuals (Darji and Soni, 2022). Cervical radiculopathy is a common neuromusculo-skeletal disorder and presents great challenges for individuals with cervical spondylosis. There are paucity of literature on effect of McKenzie exercises and neural mobilization combined with intermittent cervical traction (ICT) on various parameters in cervical radiculopathy. Therefore, the current study is designed to compare the effectiveness of McKenzie technique and neural mobilization when combined to intermittent cervical traction on pain, neck disability, hand grip and neck proprioception in patients with cervical radiculopathy.





 
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