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CTRI Number  CTRI/2024/08/072200 [Registered on: 09/08/2024] Trial Registered Prospectively
Last Modified On: 01/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Other 
Public Title of Study   3D-MFR in individuals with Cervical Spondylosis 
Scientific Title of Study   Effectiveness of 3D-MFR on Proprioception, Pain, ROM and Function in Cervical Spondylosis: A Randomized Controlled 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  Bhakti Gauns 
Designation  Post Graduate Student 
Affiliation  KAHER Institute of Physiotherapy 
Address  KAHER Institute of Physiotherapy, Department of Orthopaedic Physiotherapy, OPD no. 39, Room no. 18, Nehru Nagar Belagavi Karnataka

Belgaum
KARNATAKA
590010
India 
Phone  9370559011  
Fax    
Email  bhaktigauns@icloud.com  
 
Details of Contact Person
Scientific Query  
Name  Aarti Welling 
Designation  Assistant Professor 
Affiliation  KAHER Institute of Physiotherapy 
Address  KAHER Institute of Physiotherapy, Department of Orthopaedic Physiotherapy, OPD no. 39, Room no. 18, Nehru Nagar Belagavi Karnataka

Belgaum
KARNATAKA
590010
India 
Phone  9448814569  
Fax    
Email  aartiwell88@gmail.com  
 
Details of Contact Person
Public Query  
Name  Aarti Welling 
Designation  Assistant Professor 
Affiliation  KAHER Institute of Physiotherapy 
Address  KAHER Institute of Physiotherapy, Department of Orthopaedic Physiotherapy, OPD no. 39, Room no. 18, Nehru Nagar Belagavi Karnataka


KARNATAKA
590010
India 
Phone  9448814569  
Fax    
Email  aartiwell88@gmail.com  
 
Source of Monetary or Material Support  
KLE Academy of Higher Education and Research, Nehru Nagar Belagavi Karnataka- India, 590010  
 
Primary Sponsor  
Name  KLE Academy of Higher Education and Research Nehru Nagar Belagavi Karnataka India  
Address  KAHER Institute of Physiotherapy, Department of Orthopaedic Physiotherapy, OPD no. 39, Room no. 18, Nehru Nagar Belagavi Karnataka  
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 Aarti Welling  KLEs Dr. Prabhakar Kore Hospital and Medical Research Centre  KAHER Institute of Physiotherapy, Department of Orthopaedic Physiotherapy, OPD no. 39, Room no. 18, Nehru Nagar Belagavi Karnataka
Belgaum
KARNATAKA 		 9448814569

aartiwell88@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KLE Academy of Higher Education and Research, Nehru Nagar Belagavi Karnataka- India, 590010  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M479||Spondylosis, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  3D-MFR + Conventional Treatment  3D MFR along with Conventional Treatment will be given for 2 Weeks alternate days, 6 sessions in total. 
Comparator Agent  Sham MFR+ Conventional Treatment  Sham MFR+ Conventional Treatment will be given for 2 Weeks alternate days, 6 sessions in total. 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Participants:
1. of all gender aged between 25-65 years diagnosed radiologically with cervical spondylosis
2. who report a pain intensity more than 3cm on visual analogue scale
3.  willing to participate in the study
 
 
ExclusionCriteria 
Details  Participants with history of:
1. psychological deficits hindering co-operation with treatment
2. neurological deficits (loss of sensations, paralysis)
3. active inflammatory conditions (rheumatic arthritis, ankylosing
   spondylitis)
4.Contraindications to 3D-MFR like, Open wounds, previous neck surgery, cervical spine fracture, recent trauma, severe skin diseases like dermatitis
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Neck proprioception using Joint repositioning error test, Pain using Visual analogue scale , Range of motion with Goniometer and Function using Neck disability index  At baseline after 2 weeks of treatment 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="36"
Sample Size from India="36" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   N/A 
Date of First Enrollment (India)   16/08/2024 
Date of Study Completion (India) 12/03/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 12/03/2025 
Estimated Duration of Trial   Years="0"
Months="10"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
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   Effectiveness of 3D-MFR on Proprioception, Pain, ROM and Function  in Cervical Spondylosis : A Randomized Controlled trial
Aim of the study –  To determine and compare the effect of 3D- MFR and sham release along with conventional physical therapy in Cervical Spondylosis.
Null hypothesis H0– There will be no difference in the effect of 3D- MFR and Sham release along with conventional physical therapy on neck proprioception, pain, ROM and function in Cervical Spondylosis.
Alternate Hypothesis H1- There will be difference in the effect of 3D- MFR and Sham release along with conventional physical therapy on neck proprioception, pain, ROM and function in Cervical Spondylosis. 
Inclusion criteria- â€¢Participants:1. of all gender aged between 25-65 years diagnosed radiologically with cervical spondylosis, 2. who report a pain intensity more than 3 on visual analogue scale, 3.  willing to participate in the study

Exclusion criteria: â€¢Participants with history of:1. psychological deficits hindering co-operation with treatment 2. neurological deficits (loss of sensations, paralysis) 3. active inflammatory conditions (rheumatic arthritis, ankylosing spondylitis) 4. contraindications to 3D-MFR like, Open wounds, previous neck surgery, cervical spine fracture, recent trauma, severe skin diseases like dermatitis.

A written informed consent will be obtained from the participants. A brief demographic data will be obtained from the subjects prior to the assessment. Baseline assessment of the participants will be done before the intervention. Then the participants will be divided into two groups i.e. Group A (n= 18) and Group B(n=18). Group A will be given 3D-MFR with conventional physical therapy and group B will be given Sham treatment and conventional physical therapy. Post- intervention data will be collected and analysed.



 
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