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CTRI Number  CTRI/2024/03/063878 [Registered on: 08/03/2024] Trial Registered Prospectively
Last Modified On: 06/03/2024
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   Manual therapy treatments for patients with neck and arm pain. 
Scientific Title of Study   Effectiveness of Mulligan Mobilization with Neural Glides Versus Conventional Therapy in C5 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  Sweta Verma 
Designation  Student 
Affiliation  Lovely Professional University 
Address  Department of Physiotherapy, school of allied medical sciences

Kapurthala
PUNJAB
144411
India 
Phone  09041691502  
Fax    
Email  Vermasweta907@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Naina Joshi 
Designation  Assistant Professor 
Affiliation  Lovely Professional University 
Address  Department of Physiotherapy, School of allied medical science, room no. 4-213

Kapurthala
PUNJAB
144411
India 
Phone  9888855000  
Fax    
Email  nainajijoshi@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Sweta Verma 
Designation  Student 
Affiliation  Lovely Professional University 
Address  Department of physiotherapy, school of allied medical sciences

Kapurthala
PUNJAB
144411
India 
Phone  09041691502  
Fax    
Email  Vermasweta907@gmail.com  
 
Source of Monetary or Material Support  
Department of physiotherapy, School of allied medical science, Lovely Professional University, Jalandhar- Delhi GT road, Phagwara, Punjab, India- 144411 
 
Primary Sponsor  
Name  Sweta Verma 
Address  Lovely Professional University Jalandhar-G.T. road 
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 
Sweta Verma  Uni hospital, Lovely professional University  Physiotherapy OPD, Department of Physiotherapy, school of allied medical sciences, room no. 3- 105
Kapurthala
PUNJAB 
9041691502

vermasweta907@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE, LOVELY PROFESSIONAL UNIVERSITY (ICE- LPU)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Cervical Radiculopathy 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional therapy  Patient will be given neural mobilization in supine lying with shoulder abduction external rotation to 110Ëš and flex the elbow to 90Ëš. When therapist will move patient’s wrist in extension, patient will take his neck in side flexion towards other hand. Neck stretching will be given for sternocleidomastoid, upper trapezius, suboccipital, scalene muscles (3 repetitions with 30 second hold). Post treatment neck isometric exercises will be advised to the patients 10 repetition each. 
Intervention  Mulligan mobilization with neural glides.  The patient is sitting on a chair while the therapist stood behind them. The therapist uses the medial aspect of right thumb and left thumb reinforcing it, apply pressure to the spinous process of the C5 vertebrae, SNAG(Sustained natural appophyseal glide) technique is applied- patient is encouraged to perform neck flexion, and the therapist maintained the pressure with their thumb during this movement. As the patient reached the end of their pain-free range of motion in the neck, they were encouraged to give overpressure with their other hand, which will facilitate a deeper joint glide. This position will be held for 6 seconds. The patient then returned their neck to the starting position and this treatment is repeated for a total of 3 sets, with 6 repetitions in each set. The therapist uses the medial aspect of right thumb and left thumb reinforcing it, apply pressure to the facet joint of the C5 vertebrae, second therapists one hand will be over the upper scapula of the patient to prevent elevation other hand will take patients affected upper limb in shoulder abduction external rotation to 110Ëš and flex the elbow to 90Ëš. SNAG (Sustained natural appophyseal glide) technique is applied- patient is encouraged to perform neck side flexion, and the therapist maintained the pressure with their thumb during this movement. As the patient reached the end of their pain-free range of motion in the neck, they are encouraged to give overpressure with their other hand, which will facilitate a deeper joint glide, simultaneously neural mobilization is applied patient is asked to extend wrist to 10Ëš. This position will be held for 6 seconds. The patient then returned their neck and elbow to the starting position and this treatment is repeated for a total of 3 sets, with 6 repetitions in each set. Post treatment neck isometric exercises will be advised to the patients 10 repetition each. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Age group 20-50 years;
Unilateral cervical radiculopathy along with motor and/or sensory symptoms;
Both male and female;
Positive for ULTT, spurling test, cervical distraction test, ipsilateral cervical rotation less than 60 degree;
Not taking any medication for pain;
Voluntary participation. 
 
ExclusionCriteria 
Details  Bilateral cervical radiculopathy;
Musculoskeletal disease (torticollis, trapizitis, severe muscle spasm, muscular dystrophy, scoliosis, osteoarthritis, benign paroxysmal positional vertigo), Cardiovascular and respiratory disease;
Patients who are undergoing treatment for neck pain with other means of physiotherapy or medication at the time of the study;
Cervical spine fracture, surgery or other pathologies;
Central Nervous System (CNS) involvement (stroke, traumatic brain injury, cerebral palsy);
Medical red flags (tumour, rheumatoid arthritis (RA), osteoporosis, thyroid etc.). 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Visual Analog Scale,
2. Neck Disability Index 
1. 12 times
2. 4 times 
 
Secondary Outcome  
Outcome  TimePoints 
1. Range of Motion  1. 4 times 
 
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   Phase 3 
Date of First Enrollment (India)   16/03/2024 
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="6"
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 which involves nerve roots which gets inflamed or damaged, results in numbness or tingling sensation, weakness, pain radiating towards upper limbs either on one side or both sides and sometimes it may radiate towards upper back or chest. Most common causes of cervical radiculopathy are osteophyte formation or herniated cervical intervertebral disc. The average annual incidence of cervical radiculopathy is about 83 per 100,000 people in the entire population. Sixth and seventh cervical nerve roots are most commonly involved in cervical radiculopathy due to increased mobility at C5-C6 and C6-C7 cervical vertebral levels. A person having neck pain 213radiating towards upper limb suffers more level of disability than people suffering with neck pain alone.

This RCT will help us know the effects of neural glides applied with Mulligan mobilization. The added benefits of neural glides can also be tested through statistical calculations which can be an effective intervention to alleviate pain in population with C5 cervical radiculopathy. The purpose of the study is to determine the effect of Mulligan mobilization with neural glides compared to conventional therapy in patients with C5.

 
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