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CTRI Number  CTRI/2024/09/074504 [Registered on: 27/09/2024] Trial Registered Prospectively
Last Modified On: 24/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Other 
Public Title of Study   Impact of Magnesium spray on Sleep and Pain Relief in Indian Military Personnel with Long-Term Neck Pain 
Scientific Title of Study   Effect of Transdermal Magnesium on Sleep Quality and Patients perception of change among Indian Military personnel with Chronic Neck Pain- A pilot and Feasibility 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 Mohammad Sidiq 
Designation  Associate Professor 
Affiliation  Galgotias University 
Address  Room No B316 Galgotias University Department of Physiotherapy School of Allied and Health Sciences Opposite Buddha International Circuit G.B Nagar Greater Noida India

Gautam Buddha Nagar
UTTAR PRADESH
203201
India 
Phone  6006204628  
Fax    
Email  sidufatima@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Tanvi Kumari 
Designation  Student 
Affiliation  Galgotias University 
Address  Room No E004 Galgotias University Department of Physiotherapy School of Allied and Health Sciences Opposite Buddha International Circuit G.B Nagar Greater Noida India

Gautam Buddha Nagar
UTTAR PRADESH
203201
India 
Phone  7011605089  
Fax    
Email  katochtanvi3@gmail.com  
 
Details of Contact Person
Public Query  
Name  Tanvi Kumari 
Designation  Student 
Affiliation  Galgotias University 
Address  Room No E004 Galgotias University Department of Physiotherapy School of Allied and Health Sciences Opposite Buddha International Circuit G.B Nagar Greater Noida India

Gautam Buddha Nagar
UTTAR PRADESH
203201
India 
Phone  7011605089  
Fax    
Email  katochtanvi3@gmail.com  
 
Source of Monetary or Material Support  
Research and Development Cell,Galgotias University Plot No 2,Sector 17A ,Opposite Buddha International Circuit Greater Noida Uttar Pradesh India 203201 
 
Primary Sponsor  
Name  Galgotias University Greater Noida 
Address  Room NO C113,Galgotias University Plot No 2,Sector 17A, Opposite Buddha International Circuit, Greater Noida 203201 
Type of Sponsor  Research institution 
 
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 Mohammad Sidiq  Galgotias University  Room No B317,Department of Physiotherapy, Galgotias University Plot No 2,Sector 17A Opposite Buddha International Circuit Gautam Buddha Nagar Greater Noida India
Gautam Buddha Nagar
UTTAR PRADESH 		 6006204628

sidufatima@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Departmental Research Committee,Galgotias University  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M999||Biomechanical lesion, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Standard Physiotherapy Care  The control group will receieve standard physiotherapy for neck pain. It will include hot fomentation for 10 minutes followed by isotonic neck exercises 3 sets twice weekly for 4 weeks. 
Intervention  Transdermal Magnesium Spray  Participants in the intervention group will receive hot fomentation for 10 minutes followed by isotonic neck exercises. magnesium supplementation using pure magnesium sprays 10 sprays twice a weeks. Detailed instructions on dosage and administration will be provided to participants. Participants will be instructed to adhere strictly to the supplementation regimen. Total duration of the study will be 4 weeks.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Male 
Details  1.Individual with persistent neck pain(more than 12 weeks).
2.Adult aged between 18-45 yrs old.
3.Only male patients will be included in the study. 
 
ExclusionCriteria 
Details  1.Patient with any surgery or fracture.
2.Patient suffering from Rheumatoid arthritis(RA).
3.Patient with any open wound.
4.Individual not willing to participate. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Pittsburgh Sleep Quality Index
WHO FIVE WELL-BEING INDEX


 		 Baseline 4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Evaluate the subjective effect on quality of life among patients with persistent neck pain.  Baseline 4 weeks 
NECK DISABILITY INDEX

 		 Baseline 4 weeks 
 
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 4 
Date of First Enrollment (India)   18/10/2024 
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="2"
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 - 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 -  Statistical Analysis Plan

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [katochtanvi3@gmail.com].

  6. For how long will this data be available start date provided 28-02-2025 and end date provided 28-02-2075?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Pilot and Feasibility investigated the impact of transdermal magnesium supplementation on both sleep quality and patients’ perception of change among adults experiencing persistent neck pain. The study aimed to address an area of clinical interest, recognizing the potential benefits of magnesium in managing both pain and sleep disturbances. Participants will be randomly assigned to either the experimental group, receiving transdermal magnesium supplementation, or the control group. Over the course of the trial, the experimental group applied transdermal magnesium spray (10 sprays) regularly, while the control group will receive standard physiotherapy care. Sleep quality and patients’ perception of change were evaluated using PSI.


The findings of the RCT shed light on the potential efficacy of transdermal magnesium supplementation in improving sleep quality and alleviating neck pain among adults with persistent neck pain. By incorporating patients’ perception of change, the study provided a holistic understanding of the intervention’s impact on individuals’ subjective experiences and overall well-being.


This research will contribute to the growing body of evidence supporting the role of magnesium supplementation in managing chronic pain conditions and associated sleep disturbances. Furthermore, it underscores the importance of considering patient-reported outcomes alongside objective measures in assessing treatment efficacy and enhancing patient-centered care strategies. Further studies may delve deeper into the mechanisms underlying the observed effects and explore optimal dosing regimens for transdermal magnesium supplementation in this population. 
 
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