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CTRI Number  CTRI/2024/03/064936 [Registered on: 28/03/2024] Trial Registered Prospectively
Last Modified On: 05/04/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Improving Sleep Quality & Perception of Change: over skin application of Magnesium for Adults with Neck Pain 
Scientific Title of Study   Effect of Trandermal Magnesium on Sleep quality and Patients perception of change among adults with persistent neck pain- A randomzied 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  Dr Mohammad Sidiq 
Designation  Associate Professor 
Affiliation  Galgotias University 
Address  Room No B-319, Department of Physiotherapy, School of Allied Health Sciences,Plot No 2, Sector 17A, Opposite Buddha International Circuit, Greater Noida

Gautam Buddha Nagar
UTTAR PRADESH
203201
India 
Phone  6006204628  
Fax    
Email  sidufatima@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Mohammad Sidiq 
Designation  Associate Professor 
Affiliation  Galgotias University 
Address  Room No B-319, Department of Physiotherapy, School of Allied Health Sciences,Plot No 2, Sector 17A, Opposite Buddha International Circuit, Greater Noida


UTTAR PRADESH
203201
India 
Phone  6006204628  
Fax    
Email  sidufatima@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Aksh Chahal 
Designation  Professor  
Affiliation  Galgotias University 
Address  Room No B-319, Department of Physiotherapy,School of Allied Health Sciences,Plot No 2, Sector 17A, Opposite Buddha International Circuit, Greater Noida

Gautam Buddha Nagar
UTTAR PRADESH
203201
India 
Phone  9711774174  
Fax    
Email  drakshchahal@gmail.com  
 
Source of Monetary or Material Support  
Research and Development Cell, Room No C-112, Galgotias University Plot No 2, Sector 17A, Opposite Buddha International Circuit, Greater Noida 203201 
 
Primary Sponsor  
Name  Galgotias University 
Address  Room No C-112, 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  Department of Physiotherapy, Galgotias University  Plot No 2, Sector 17A, Opposite Buddha International circuit, Greater Nodia, 203201
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 starndard physiotherapy for neck pain.It will include hot fomentation for 10 minutes followed by isotonic neck exercises with therbands 3 sets twice weekly for 6 weeks. 
Intervention  Transdermal Magnesium Spray  Participants in the intervention group will receive hot fomentation for 10 minutes followed by isotonic neck exercises using theraband 3 sets twice daily. In addition they will receive magnesium supplementation using pure mangesium Spray 10 sprays twice weekly for 6 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 stdudy will be 6 weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Persistent Neck Pain duration more than 3 months.
2. Health Status: Individuals without diagnosed medical conditions affecting magnesium metabolism or utilization.
3. Ability to Provide Informed Consent: Participants must be capable of understanding the study procedures and providing informed consent.
4. Availability: Participants must be available for the duration of the study and willing to adhere to the intervention protocol.

 
 
ExclusionCriteria 
Details  1. Known Magnesium Deficiency: Individuals with diagnosed magnesium deficiency or receiving magnesium supplementation at the time of enrollment.
2. Chronic Medical Conditions: Participants with chronic medical conditions (e.g., renal disease, gastrointestinal disorders) known to affect magnesium absorption or metabolism.
3. Medication Use: Individuals currently taking medications known to interfere with magnesium absorption or metabolism (e.g., proton pump inhibitors, diuretics).
4. Pregnancy or Lactation: Pregnant or lactating individuals, as magnesium requirements may differ during these periods.
5. Allergy or Sensitivity: Individuals with known allergies or sensitivities to magnesium or any components of the supplementation product (e.g., Spray 10 spray).
6. Participation in Other Clinical Trials: Participants currently enrolled in or have participated in other clinical trials within a specified timeframe prior to enrollment.
7. Inability to Comply: Individuals unable or unwilling to adhere to the study protocol, including attending scheduled assessments and following supplementation instructions.

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Pressure pain threshold using Algometer
The Petersberg Sleep Quality Index
Patient Global Perception of Change questionnaire 		 Baseline, 6 weeks and 12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Neck Disability Index will be used to assess the degree of disability & limitations experienced by individuals suffering from neck pain.
 		 Baseline, 6 weeks & 12 weeks 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="73" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   19/04/2024 
Date of Study Completion (India) 08/04/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

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

  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 [sidufatima@gmail.com].

  6. For how long will this data be available start date provided 18-04-2024 and end date provided 18-04-2026?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  
The randomized controlled trial (RCT) 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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