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CTRI Number  CTRI/2023/11/060139 [Registered on: 22/11/2023] Trial Registered Prospectively
Last Modified On: 20/11/2023
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   Exercises to improve low back pain 
Scientific Title of Study   Effectiveness of kinetic control versus mckenzie exercises on functional outcomes in patients with lumbar radiculopathy - A Single Blinded Randomized Control Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR KANCHAN DINKARRAO JOSHI 
Designation  MPT First year Musculoskeletalsciences 
Affiliation  D V V P Fs College of Physiotherapy 
Address  Department of musculoskeltal physiotherapy basement Dr Vithalrao Vikhe Patil college of physiotherapy Ahmednagar Ahmadnagar MAHARASHTRA 414111 India Ahmadnagar MAHARASHTRA 414111 India

Ahmadnagar
MAHARASHTRA
414111
India 
Phone  7020410341  
Fax    
Email  joshikanchan1812@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR KANCHAN DINKARRAO JOSHI 
Designation  MPT First year Musculoskeletalsciences 
Affiliation  D V V P Fs College of Physiotherapy 
Address  Department of musculoskeltal physiotherapy basement Dr Vithalrao Vikhe Patil college of physiotherapy Ahmednagar Ahmadnagar MAHARASHTRA 414111 India Ahmadnagar MAHARASHTRA 414111 India

Ahmadnagar
MAHARASHTRA
414111
India 
Phone  7020410341  
Fax    
Email  joshikanchan1812@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Deepak Anap 
Designation  HOD Musculoskeletal sciences 
Affiliation  D V V P Fs College of Physiotherapy 
Address  Department of musculoskeltal physiotherapy basement Dr Vithalrao Vikhe Patil college of physiotherapy Ahmednagar Ahmadnagar MAHARASHTRA 414111 India Ahmadnagar MAHARASHTRA 414111 India

Ahmadnagar
MAHARASHTRA
414111
India 
Phone  9890200972  
Fax    
Email  deepak.anap@hotmail.com  
 
Source of Monetary or Material Support  
DVVPFs College of Physiotherapy opp Govt milk dairy MIDC Ahmednagar 
 
Primary Sponsor  
Name  DVVPFs College of Physiotherapy 
Address  Department of musculoskeletal sciences Block 1 basement DVVPFs college of physiotherapy Oppo Govt Milk Dairy MIDC 414111 Ahmadnagar MAHARASHTRA 
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 
DR DEEPAK ANAP  D V V P Fs College of Physiotherapy  Department of Musculo skeletalsciences Opp Govt Milk Dairy M I D C Ahmednagar 414111 Ahmadnagar MAHARASHTRA Ahmadnagar Ahmadnagar MAHARASHTRA
Ahmadnagar
MAHARASHTRA 
9890200972

deepak.anap@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
DVVPFS College of Physiotherapy Institutional ethical Committe Ahmednagar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, (2) ICD-10 Condition: M488||Other specified spondylopathies,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Mckenzie Exercises  Mckenzie Exercises: In this intervention patient have to perform directional based exercises on the basis of centralization or peripheralization of neurological symptoms .It includes Extension biased or Flexion Biased exercises for lumbar spine. Each exercise will be performed for 10 repetitions. 
Intervention  Motor control exercises.   Kinetic control exercises: Each patient in group (A) will receive kinetic control retraining 3 sessions per week, for 4 weeks. For each movement direction, specific control tests will be conducted. The direction and site of the uncontrolled movement will be evaluated using special tests in accordance with the pain history of the patient. The tests will be chosen according to the patient’s symptoms; screening of all patients will done through at least three tests in each direction according to the patient’s symptoms. The aim of each test and the way of its performance will be explain to each patient.The tests of each direction of movement control included flexion movement control tests, extension movement control tests and rotation/side bending control tests.Kinesthetic training for awareness of safe motion & positions must procedes stabilization training. Activation of deep segmental muscles of trunk with extremity motions are added to the stabilization program to coordinate segmental muscle activity with global stabilizing musculature. Hence Lumbar Stabilization exercises will be performed by the patients.  
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  •Subjects from both Genders diagnosed low back pain with radiculopathy and flexion and extension uncontrolled movement.
•Patients with lumbar radiculopathy due to lumbar disc prolapse(posterolateral or lateral disc prolapse (L4-L5/ L5-S1 levels) with clinical confirmation through the applied examination with MRI.
•Patients who are on the medications for the lumbar radiculopathy.
•The radiculopathy signs will be identified by the presence of LBP with numbness radiating below the knee, and the duration of illness will be from 3-6 months.
•Muscle strength deficit in any of the L4-S1myotomes;

 
 
ExclusionCriteria 
Details  •Females with Gynecological problems that may cause low back pain.
•Patients with a previous spinal surgery, other radicular symptoms causes (e.g.: piriformis syndrome, diabetic neuropathy).
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Pain, Disability, Range Of Motion, Strength  Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
Pain,Disability, Range Of Motion, Strength  4 week 
 
Target Sample Size   Total Sample Size="52"
Sample Size from India="52" 
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)   30/11/2023 
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)   Open to Recruitment 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [joshikanchan1812@gmail.com].

  6. For how long will this data be available start date provided 18-12-2024 and end date provided 31-12-2029?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   The study is to see the effectiveness of kinetic control versus Mckenzie exercises on functional outcomes in patients with lumbar radiculopathy: A Single Blinded Randomized Control Trial. 52 subjects 26 in each
group will be recruited based on inclusion and exclusion criteria. There will be 2 groups, Motor control exercises and Mckenzie exercise program will be given to each group for 4 weeks. Total treatment protocol will be of 4 weeks. Intervention should be given thrice a week upto 4 weeks. Data will be analyzed statistically
 
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