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CTRI Number  CTRI/2020/01/022881 [Registered on: 20/01/2020] Trial Registered Prospectively
Last Modified On: 14/01/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Effectiveness of Maitland techniques and specific exercise program on pain, function and range of motion in patients with neck pain.  
Scientific Title of Study   Effectiveness of Maitland techniques and specific exercise program on pain, function and range of motion in patients with cervical radiculopathy: A Randomized Controlled Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Kalyani Prakash Toshniwal 
Designation  Postgraduate student 
Affiliation  MGM Institute of Physiotherapy,Aurangabad 
Address  MGM Institute of Physiotherapy,N-6,Cidco, Aurangabad.
OPD no.1,Musculoskeletal department,MGM Institute of Physiotherapy N6 cidco, Aurangabad 431003
Aurangabad
MAHARASHTRA
431003
India 
Phone  8408999939  
Fax    
Email  kalyanitoshniwal3@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sibi Daniel Joseph 
Designation  associate professor  
Affiliation  MGM Institute of Physiotherapy,N-6,Cidco, Aurangabad. 
Address  MGM Institute of Physiotherapy,N-6,Cidco, Aurangabad.

Aurangabad
MAHARASHTRA
431003
India 
Phone  9096834592  
Fax    
Email  sibdanjo2k@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Kalyani Prakash Toshniwal 
Designation  Postgraduate student 
Affiliation  MGM Institute of Physiotherapy,Aurangabad 
Address  MGM Institute of Physiotherapy,N-6,Cidco, Aurangabad.
OPD no.1,Musculoskeletal department,MGM Institute of Physiotherapy N6 cidco, Aurangabad 431003
Aurangabad
MAHARASHTRA
431003
India 
Phone  8408999939  
Fax    
Email  kalyanitoshniwal3@gmail.com  
 
Source of Monetary or Material Support  
MGM Institute of Physiotherapy,N6 cidco, Aurangabad 431003 
 
Primary Sponsor  
Name  MGM Institute of Physiotherapy Aurangabad  
Address  MGM Institute of Physiotherapy,N-6, Cidco Aurangabad-431003 
Type of Sponsor  Private medical college 
 
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 
Kalyani Prakash Toshniwal  MGM Institute of Physiotherapy, Aurangabad   OPD no.1,Musculoskeletal department,MGM Institute of Physiotherapy N6 cidco, Aurangabad 431003
Aurangabad
MAHARASHTRA 
8408999939

kalyanitoshniwal3@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
MGM-ECRHS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Maitland Manual therapy techniques,TENS,Neck isometrics, Moist heat therapy  1)Maitland Manual therapy techniques:- A) Rotation mobilization at cervical spine performed for 10repetions of 30 seconds with 3 to 4 grade, as described by Maitland et al. B) Lateral glide in a flexed position at the cervical spine performed for 10 repetions of 30 seconds with 3 to 4 grade, as described by Maitland et al. C) Anterosuperior lateral glide at the cervical spine performed for 10repetions of 30 seconds with 3 to 4 grade, as described by Maitland et al. Any two of the above three techniques will be performed on the patients according to the results of biomechanical evaluation. 2)Home exercise program:- A)Repeated active rotation movements (cervical spine rotation in the direction contralateral to the affected side) performed for 10 repetitions 10 times per day. 3)TENS:- Conventional TENS was applied for 30 mins. Stimulus was given in continuous trains of 150µs square pulse at 80Hz. Intensity was adjusted according to the patients comfort. 4) Neck Isometrics. 5) Moist heat therapy. Each participant took part in 8 treatment sessions during a 4 week period.  
Comparator Agent  TENS,Neck isometrics, Moist heat therapy.   1)TENS:- Conventional TENS was applied for 30 mins. Stimulus was given in continuous trains of 150µs square pulse at 80Hz. Intensity was adjusted according to the patients comfort. 2)Neck Isometrics . 3)Moist heat therapy. Each participant took part in 8 treatment sessions during a 4 week period.  
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1) The subject should have pain, paresthesia, or numbness in 1 upper limb, with cervical or periscapular pain of less than 3 months in duration.
2) The subject should have positive responses to at least 3 of the 4 following clinical tests: spurling A test, upper-limb tension test A, cervical distraction test, and less than 60° of cervical rotation to the painful side.
 
 
ExclusionCriteria 
Details  1) Previous history of surgery to the cervicothoracic spine.
2) Bilateral symptoms.
3) Signs of upper motor neuron impairments.
4) Cervical spine injection in the previous 4 weeks.
5) Current use on steroidal anti-inflammatory drugs. 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Neck Disability Index:- neck pain related dysfunction.
2. Numeric Pain Rating Scale:- pain in neck and upper limb.
3. Cervicothoracic Mobility:- active cervical ROM.
 
 
Baseline on the 1st day.
Post intervention at the end of 4th week.
Follow up after 1 month.
 
 
 
Secondary Outcome  
Outcome  TimePoints 
1. Neck Disability Index:- neck pain related dysfunction at the end of 4 weeks and after 3 months.
2. Numeric Pain-Rating Scale:- pain in neck and upper limb at the end of 4 weeks and after 3 months.
3. Cervicothoracic Mobility:- active cervical ROM at the end of 4 weeks and after 3 months.
 
 
10-15 minutes 
 
Target Sample Size   Total Sample Size="34"
Sample Size from India="34" 
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)   21/01/2020 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

This randomized controlled trial is to see the effectiveness of Maitland techniques and specific exercise program on pain, function and range of motion in 34 patients with cervical radiculopathy. Movements such as contralateral rotation, flexion, and contralateral side bending that increase the size of the IVF but may decompress an affected nerve root. Therefore, acute and subacute rehabilitation program for cervical radiculopathy should include techniques or exercises to increase the size of the IVF and, exclude movements and positions that decrease the size of the IVF.  Since there was no control group included in this study the possibility of spontaneous resolution of symptoms could not be ruled out over the course of the study. So we decided to add a control group and see the effectiveness in the study. There will be two groups experimental group receiving manual therapy techniques (rotation mobilization, lateral glide, anterosuperior lateral glide at cervical spine), home exercise program, TENS, neck Isometrics, moist heat therapy and control group receiving same exercises as experimental group except manual therapy techniques and home exercise program. Patient will receive total 8 treatment sessions (twice in a week for a period of 4 weeks). The outcome measures will be Neck and disability index, cervicothoracic mobility (CROM), Numeric Pain-Rating Scale at baseline, at 4th week and after 1 month.

 
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