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CTRI Number  CTRI/2024/08/072957 [Registered on: 23/08/2024] Trial Registered Prospectively
Last Modified On: 31/12/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   To understand relationship of Low Back Pain, Restless Leg Syndrome and Sleep disturbance in Pregnant Females 
Scientific Title of Study   Association OF Low Back Pain, Restless Leg Syndrome and Insomnia in Third Trimester Females: A Cross-sectional study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sahil Sharma 
Designation  BPT Undergraduate student 
Affiliation  Maharishi Markandeshwar Medical College and Hospital Kumarhatti Solan 
Address  Maharishi Markandeshwar Medical College and Hospital, Department of Physiotherapy, Room no. 510, Kumarhatti Solan
VPO Patrighat Tehsil Baldwara District Mandi HP Pin code 175023
Solan
HIMACHAL PRADESH
173229
India 
Phone  07018353404  
Fax    
Email  sahil4u1998@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Sarita Khadayat 
Designation  Assistant Professor 
Affiliation  Maharishi Markandeshwar Medical College and Hospital, Kumarhatti, Solan 
Address  Maharishi Markandeshwar Medical College and Hospital, Department of Physiotherapy, Room no. 510, Kumarhatti Solan
Maharishi Markandeshwar Medical College and Hospital Kumarhatti Solan
Solan
HIMACHAL PRADESH
173229
India 
Phone  8979997426  
Fax    
Email  khdytsarita@gmail.com  
 
Details of Contact Person
Public Query  
Name  Arushi Mishra 
Designation  Assistant Professor 
Affiliation  Maharishi Markandeshwar Medical College and Hospital, Kumarhatti, Solan 
Address  Maharishi Markandeshwar Medical College and Hospital, Department of Physiotherapy,Room no. 510, Kumarhatti Solan
Maharishi Markandeshwar Medical College and Hospital Kumarhatti Solan
Solan
HIMACHAL PRADESH
173229
India 
Phone  8219368147  
Fax    
Email  arushimishra799@gmail.com  
 
Source of Monetary or Material Support  
Maharishi Markandeshwar Medical College and Hospital Department of Physiotherapy, Kumarhatti, Solan, Pincode 173229, Himachal Pradesh, India 
 
Primary Sponsor  
Name  Sahil Sharma 
Address  Maharishi Markandeshwar Medical College and Hospital, Department of Physiotherapy Room no. 510, Kumarhatti, Solan Pincode 173229, Himachal Pradesh, India  
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
Sarita Khadayat  Maharishi Markandeshwar Medical College and Hospital Kumarhatti Solan 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Sahil Sharma  Maharishi Markandeshwar Medical College and Hospital, Kumarhatti, Solan  Department of Physiotherapy Room number 510
Solan
HIMACHAL PRADESH 		 07018353404

sahil4u1998@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE MAHARISHI MARKANDESHWAR MEDICAL COLLEGE AND HOSPITAL  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O269||Pregnancy related conditions, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Not Applicable  Not Applicable 
Intervention  Not Applicable  Not Applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  1 Gestational age between 28 to 40 weeks
2 Female with any history of low back pain, restless leg syndrome, insomnia during third trimester
3 Females with pain score on Numeric pain rating scale more than 5 
 
ExclusionCriteria 
Details  1 Women with any previous history of low back pain
2 Any history of surgical intervention of lumbar spine
3 History of carcinoma
4 Spinal deformities
5 Pelvic fracture
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Oswestry Disability Index (ODI)  At baseline 
 
Secondary Outcome  
Outcome  TimePoints 
Restless Leg Syndrome Questionnaire (Rating Scale)  At baseline 
Sleep Quality Scale (SQS)  At baseline 
 
Target Sample Size   Total Sample Size="272"
Sample Size from India="272" 
Final Enrollment numbers achieved (Total)= "300"
Final Enrollment numbers achieved (India)="300" 
Phase of Trial   N/A 
Date of First Enrollment (India)   27/09/2024 
Date of Study Completion (India) 30/12/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

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

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

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [sahil4u1998@gmail.com].

  6. For how long will this data be available start date provided 27-09-2024 and end date provided 01-03-2025?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

This study will be conducted over 6 months period. The data will be collected from different OPDs of Maharishi Markandeshwar Medical College and Hospital, Solan, Himachal Pradesh. A total of 272 pregnant females in their third trimester of pregnancy with history of low back pain, restless leg syndrome and insomnia will be recruited. Prior to administrating the questionnaire, a written informed consent will be obtained from each pregnant female. Each participant will undergo small interview method after that participant will be provided with an information sheet explaining the merits and demerits of participating in the study as well as any foreseen benefits. After that, sociodemographic and anthropometric data such as age, height, weight will be measured. Before administering the questionnaire, each participant will undergoing a small interactive interview with principal investigator. Principal investigator will be providing all the information regarding the questionnaire and how to answer the questions. This procedure will take ~ 30 minutes for complete gathering of data.

 
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