| 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
|
|
|
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
|
|
|
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 |