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CTRI Number  CTRI/2018/07/015144 [Registered on: 31/07/2018] Trial Registered Prospectively
Last Modified On: 31/07/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   comparison between the effectiveness of Mulligans Spinal Mobilization with Arm Movements and Sustained mobilization without arm movements in reducing pain and functional disabilities in patients with Cervical Radiculopathy 
Scientific Title of Study   Effectiveness of Mulligans Spinal Monilization with Arm Movements and Sustained Natural Apophyseal Glides in reducing pain and functional disabilities in patients with Cervical Radiculopathy:A comparative study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sanika Shahade 
Designation  PG Student 
Affiliation  Sancheti Institute College of Physiotherapy 
Address  Musculoskeletal Physiotherapy department Sancheti healthcare Academy Thube Park Near Nexa showroom Shivajinagar Pune-411005
Musculoskeletal Physiotherapy department Sancheti healthcare Academy Thube Park Near Nexa showroom Shivajinagar Pune-411005
Pune
MAHARASHTRA
411005
India 
Phone  7303286224  
Fax    
Email  shahadesanika@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Venu Mohan 
Designation  PG Student 
Affiliation  Sancheti Institute College of Physiotherapy 
Address  Sancheti healthcare Academy Thube Park Near Nexa showroom Shivajinagar Pune-411005
Sancheti healthcare Academy Thube Park Near Nexa showroom Shivajinagar Pune-411005
Pune
MAHARASHTRA
411005
India 
Phone  9440690707  
Fax    
Email  venumohan@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Sanika Shahade 
Designation  PG Student 
Affiliation  Sancheti Institute College of Physiotherapy 
Address  Musculoskeletal Physiotherapy department Sancheti healthcare Academy Thube Park Near Nexa showroom Shivajinagar Pune-411005
Musculoskeletal Physiotherapy department Sancheti healthcare Academy Thube Park Near Nexa showroom Shivajinagar Pune-411005
Pune
MAHARASHTRA
411005
India 
Phone  7303286224  
Fax    
Email  shahadesanika@gmail.com  
 
Source of Monetary or Material Support  
Sancheti Healthcare Academy,Sancheti Institute College of Physiotherapy, 11/12 Thube park, shivajinagar 
 
Primary Sponsor  
Name  sancheti institute college of physiotherapy 
Address  Sancheti Healthcare Academy,Sancheti Institute College of Physiotherapy, 11/12 Thube park, shivajinagar 
Type of Sponsor  Research institution and hospital 
 
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 
Sanika Shahade  Sancheti Institute of Orthopaedics and Rehabilitation (outpatient Department)  Sancheti Institute of Orthopaedics and Rehabilitation Shivajinagar, Pune-411005 Department- Physiotherapy Division- Musculoskeletal
Pune
MAHARASHTRA 
7303286224

shahadesanika@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Review Board  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  Group 1: SMWAM group  Patient sits upright on a chair. Therapist stands behind the patient. Therapist approaches the desired level of the spinous process from medial aspect of the thumb of one hand which is reinforced by the index finger of the other hand. Pure sustained transverse glide is performed from affected to unaffected side. While the glide is sustained , patient performs the desired neurodynamic movement for median nerve.(External rotation, abduction at the shoulder ,elbow extension, forearm supination ,wrist and finger extension) • Dosage: 3 sets of ten repetitions • Duration: once a day, 3 sessions for 1 week EXERCISES: 1. Neck Isometrics exercises 2. Neck range of motion exercises 3. Scapular Strengthening 4. deep neck flexor activation exs 
Comparator Agent  Group 2- SNAGS group  Procedure: Patient position: sitting upright on a chair. • Therapist position: standing behind the patient in stride stance. • Hand placement: Therapist places medial border of distal phalanx of thumb obliquely, under the spinous process of the desired level of vertebra. Therapist places pulp of the thumb of other hand reinforcing the lateral side of the thumb places earlier. The other fingers are placed comfortably on the mandible. For unilateral snags: if SNAGS are given on right side, right thumb is placed on the facet joint, which is reinforced by the left thumb. The glide is given under the spinous process/facet joint by pushing it towards the eyeball. 15 Patient is asked to perform the painful/restricted/offending movement. Therapist moves his hand along the movement of the spine to sustain the glide along. • Dosage: 3 sets of 10 repetitions. • Duration : once a day,3 sessions for 1 week EXERCISES: 1. Neck Isometrics exercises 2. Neck range of motion exercises 3. Scapular Strengthening 4. deep neck flexor activation exs 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  NRS score 4 to 7. (Moderate pain).
ï‚· Diagnosed cases of unilateral cervical radiculopathy.
 Subjects with Spurling‘s test positive.
ï‚· Subjects with ULTT-1, 2 positive.  
 
ExclusionCriteria 
Details  Spondylolisthesis
ï‚· Cervical spine fracture
ï‚· Bilateral Radiculopathy
ï‚· Any Spinal Surgery 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Numerical rating Scale
2. Cervical ROM using Universal Goniometer.
3. Neck Disability Index 
Outcome measures will be assessed pre-treatment first session and post treatment third session 
 
Secondary Outcome  
Outcome  TimePoints 
1. Numerical rating Scale
2. Cervical ROM using Universal Goniometer.
3. Neck Disability Index 
Outcome measures will be assessed pre-treatment first session and post treatment third session 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   01/08/2018 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NOt yet published 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

INTRODUCTION:

Cervical radiculopathy is a disease process marked by nerve compression from herniated disk material or arthritic bone spurs. Those can be compression, irritation, traction, and a lesion on the nerve root caused by a herniated disc, foraminal narrowing or degenerative spondylotic change leading to stenosis of the intervertebral foramen. [1, 2]

Typical symptoms of cervical radiculopathy are: irradiating arm pain corresponding a dermatomal pattern, neck pain, paraesthesia, muscle weakness in a myotomal pattern, headaches, scapular pain, sensory and motor dysfunction in upper extremities and neck. [1, 2]

Physical therapy interventions often used for the management of cervical radiculopathy include cervical traction, postural education, exercise, electrical modalities like IFT and TENS, and manual therapy applied to the cervical spine and thoracic spine. [3] 3

The Mulligan concept has its foundation built on Kaltenborn’s principles of restoring the accessory component of physiological joint movement. Mulligan proposed that injuries or sprains might result in a minor positional fault to a joint, thus altering the biomechanics at the joint, causing restrictions in physiological movement. Mobilization of the spine maybe done in the functional, weight bearing position by applying the force parallel to the spinal facet planes. It maybe oscillatory (Natural Apophyseal Glides- NAGs) or a sustained glide maintained coupled with the patient performing the offending spinal movement (Sustained NAGs- SNAGs). [1]

In 1990, Brian Mulligan introduced a technique known as: spinal mobilisations with limb movements (SMWLMs). Here, a sustained transverse glide is applied to the spinous process of a vertebra while the restricted peripheral upper or lower limb movement is performed, actively or passively. The foremost emphasis remains that the mobilization must result in symptom-free movement. Mulligan proposed that utilization of these mobilization techniques was indicated when peripheral joint limitation of movement is spinal in origin. [1]

SMWAM amalgamates the concept of neurodynamics with Mulligan’s concept that minor positional faults of joints can occur following injuries and strains, whereby joints are no longer aligned in their natural, congruent position, but are subtly maligned. IN the case of radiating pain, neural tissues may be adhered to surrounding structures, resulting in lack of sliding and gliding, and hence giving 4

additional stretch to the nerve. Due to transverse glide, the vertebral body rotates towards the same side, resulting in opening of foramina on the affected side. Adding arm movement with opened foramina will result in mobilization of neural tissues. [4, 5, 6] 5

NEED FOR THE STUDY:

The Mulligan concept is now an integral component of many manual physiotherapists clinical practice. Studies have been conducted measuring the efficacy of SNAGS, showing the beneficial effects.

Spinal mobilisation with arm movements (SMWAMs) can be used for restricted upper limb movements that could be as a result of a spinal joint dysfunction or abnormal neural dynamics. However, data regarding the effects of SMWAM is scarce.

This study aims to gain data regarding the effectiveness of Mulligan SMWAM and to obtain a comparison between the effects of the both techniques, thereby providing clinical therapists an evidence-based better choice of treatment. 6

AIM:

To compare the effects of SMWAM and SNAGS on pain, ROM and function in patients with cervical radiculopathy.

OBJECTIVES:

1. To find the effect of SMWAM on pain, cervical ROM and functional outcome in patients with cervical radiculopathy.

2. To find the effect of SNAGS on pain, cervical ROM and functional outcome in patients with cervical radiculopathy.

3. To compare the effects of SMWAM and SNAGS in patients with cervical radiculopathy. 7

RESEARCH QUESTION:

Which of the two techniques is better in relieving pain, improving ROM and function, in patients with cervical radiculopathy- SMWAM or SNAGS?

HYPOTHESIS:

There is significant difference between SMWAM and SNAGS in relieving pain, improving ROM and function in patients with cervical radiculopathy.

NULL HYPOTHESIS:

There is no significant difference between SMWAM and SNAGS in relieving pain, improving ROM and function in patients with cervical radiculopathy.

METHODOLGY:

STUDY DESIGN: Experimental study

METHOD OF SAMPLING: Simple Randomisation using computer generated random table

SAMPLE SIZE: 40 (20 in each group)

MATERIALS USED: Universal Goniometer

INCLUSION CRITERIA:

ï‚· Age group from 30 to 60 years.

ï‚· Males and females both included.

ï‚· NRS score 4 to 7. (Moderate pain).

ï‚· Diagnosed cases of unilateral cervical radiculopathy.

 Subjects with Spurling‘s test positive.

ï‚· Subjects with ULTT-1, 2 positive.

EXCLUSION CRITERIA:

ï‚· Spondylolisthesis

ï‚· Cervical spine fracture

ï‚· Bilateral Radiculopathy

ï‚· Any Spinal Surgery

13

PROCEDURE:

•Post approval by the institutional ethical committee, patients will be assessed for eligibility and informed consent will be obtained from the subjects who fulfil the inclusion criteria.

•Patients will be assigned into two groups by computerised random sampling.

•Group A will be given SMWAM and exercise therapy.

•Group B will be given SNAGS and exercise therapy.

•A pre-treatment NRS, Cervical range of motion using universal goniometer and Neck Disability Index will be performed and documented.

•Patients will receive treatment for 3 sessions for 1 week.

•A post treatment NRS, Cervical range of motion and Neck Disability Index will be performed in both the groups.

OUTCOME MEASURES:

1. Numerical rating Scale

2. Cervical ROM using Universal Goniometer.

3. Neck Disability Index.

 

 
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