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CTRI Number  CTRI/2024/10/075588 [Registered on: 21/10/2024] Trial Registered Prospectively
Last Modified On: 22/10/2024
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   Investigating how women get physiotherapy for period pain relief 
Scientific Title of Study   Assessing the Accessibility and Efficacy of Telehealth Physiotherapy in Dysmenorrhea management A Qualitative outcome measure study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Surbhi 
Designation  Associate Professor 
Affiliation  Galgotias University 
Address  Block B 3rd floor Galgotias University Plot No.2, Sector 17-A Yamuna Expressway, Greater Noida, Gautam Buddh Nagar, Uttar Pradesh, India

Gautam Buddha Nagar
UTTAR PRADESH
203201
India 
Phone  08527389589  
Fax    
Email  surbhi.kaura@galgotiasuniversity.edu.in  
 
Details of Contact Person
Scientific Query
 
Name  Surbhi 
Designation  Associate Professor 
Affiliation  Galgotias University 
Address  Block B 3rd floor Galgotias University Plot No.2, Sector 17-A Yamuna Expressway, Greater Noida, Gautam Buddh Nagar, Uttar Pradesh, India

Gautam Buddha Nagar
UTTAR PRADESH
203201
India 
Phone  08527389589  
Fax    
Email  surbhi.kaura@galgotiasuniversity.edu.in  
 
Details of Contact Person
Public Query
 
Name  Aaliya Naaz 
Designation  Student 
Affiliation  Galgotias University 
Address  Block B 3rd floor Galgotias University Plot No.2, Sector 17-A Yamuna Expressway, Greater Noida, Gautam Buddh Nagar, Uttar Pradesh, India

Gautam Buddha Nagar
UTTAR PRADESH
203201
India 
Phone  09058390775  
Fax    
Email  aaliya.21smas1010069@galgotiasuniversity.edu.in  
 
Source of Monetary or Material Support  
OPD , Physiotherapy E003 lab Galgotias university Gautam Budh Nagar Yamuna Expressway UP 203201 India 
 
Primary Sponsor  
Name  Galgotias University 
Address  Block B 3rd floor Galgotias University Plot No.2, Sector 17-A Yamuna Expressway, Greater Noida, Gautam Buddh Nagar, Uttar Pradesh, India 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 Surbhi Kaura   Galgotias University  Room No E003 Department of Physiotherapy, School of Allied Health Sciences, Galgotias University plot 2 sector 17A Yamuna expressway Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH 
8527389589

surbhi.kaura@galgotiasuniversity.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Departmental Research Committee Galgotias  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N946||Dysmenorrhea, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group A Telehealth Physiotherapy Group  Participants in this group will receive physiotherapy sessions via a telehealth platform. Each session will last approximately 30-45 minutes and will include a combination of guided exercises, pain management techniques like TENS, heat therapy and educational components focused on lifestyle modifications to manage dysmenorrhea. Sessions will be conducted twice a week for a duration of 4 weeks. Participants will also have access to instructional videos and resources through the telehealth platform. 
Comparator Agent  Group b In Person Physiotherapy  Participants in this group will attend in-person physiotherapy sessions at a designated clinic. The content and structure of these sessions will mirror those of the telehealth group, including similar exercises and pain management techniques like TENS , Heat therapy. In-person sessions will also occur twice a week for 4 weeks. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  Females aged 18 to 45years who have been clinically diagnosed with primary dysmenorrhea.
Participants who experience moderate to severe menstrual pain defined as a score of 4 or higher on the Visual Analog Scale. Participants who have access to the necessary technology like smartphone, tablet, or computer with internet access for telehealth sessions.
 
 
ExclusionCriteria 
Details  Underlying pelvic pathologies Participants currently undergoing other forms of treatment for dysmenorrhea such as acupuncture or chiropractic care. Those who are pregnant or planning to become pregnant during the study period. The exclusion criterion was a failure to agree to participate in the study 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Visual Analog Scale
Oswestry Disability Index
Patient reported outcome measurement Information system PROMIS 
baseline and 4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Working Ability, Location, Intensity, Days of Pain, Dysmenorrhea WaLIDD  Baseline and 4weeks 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   31/10/2024 
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="8"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
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  
The study aims to assess the accessibility and efficacy of telehealth physiotherapy in managing dysmenorrhea. There are two groups of patients Group A and Group B. Participants in group A will receive physiotherapy sessions via a telehealth platform. Each session will last approximately 30 to 45 minutes and will include a combination of guided exercises, pain management techniques like TENS, heat therapy and educational components focused on lifestyle modifications to manage dysmenorrhea. Sessions will be conducted twice a week for a duration of 4 weeks. Participants will also have access to instructional videos and resources through the telehealth platform Whereas participants in group B will attend in person physiotherapy sessions at a designated clinic. The content and structure of these sessions will mirror those of the telehealth group, including similar exercises and pain management techniques like TENS , Heat therapy. In-person sessions will also occur twice a week for 4 weeks. By comparing patient reported pain levels functional mobility and overall quality of life before and after telehealth interventions using Oswestry Disability Index, Patient reported outcome measurement Information system PROMIS, this research seeks to evaluate the effectiveness of telehealth physiotherapy in alleviating dysmenorrhea symptoms.

Keywords Telehealth Physiotherapy, Dysmenorrhea Management, Accessibility, Efficacy, Telemedicine, Menstrual Pain 
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