| CTRI Number |
CTRI/2025/11/096764 [Registered on: 03/11/2025] Trial Registered Prospectively |
| Last Modified On: |
31/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
COMPARING DRY CUPPING AND HOT MOIST PACK FOR SEVERE MENSTRUAL PAIN IN FEMALE ATHLETES |
|
Scientific Title of Study
|
Comparative effect of dry cupping and hot moist pack on primary dysmenorrhea and cardiovascular parameters in female athletes: A randomized clinical 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 SANJANA PAMMANNAVAR |
| Designation |
Assistant professor department of sports physiotherapy |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
Advanced Physiotherapy center,department of pediatric
physiotherapy, room no 39, sagar floor,
Belgaum
KARNATAKA
590010
India
Belgaum KARNATAKA 590010 India |
| Phone |
9380358281 |
| Fax |
|
| Email |
sanjanapammannavar@klekipt.edu.in |
|
Details of Contact Person Scientific Query
|
| Name |
Dr SANJANA PAMMANNAVAR |
| Designation |
Assistant professor department of sports physiotherapy |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
Advanced Physiotherapy center,department of pediatric
physiotherapy, room no 39, sagar floor,
Belgaum
KARNATAKA
590010
India
KARNATAKA 590010 India |
| Phone |
9380358281 |
| Fax |
|
| Email |
sanjanapammannavar@klekipt.edu.in |
|
Details of Contact Person Public Query
|
| Name |
Srushti Chavan |
| Designation |
Undergraduate student (intern) |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
Advanced Physiotherapy center,department of pediatric
physiotherapy, room no 39, sagar floor,
Belgaum
KARNATAKA
590010
India
Belgaum KARNATAKA 590010 India |
| Phone |
09663874989 |
| Fax |
|
| Email |
chavansrushti500@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLE Dr Prabhakar Kore hospital and research centre, Nehru Nagar, Belgaum |
|
|
Primary Sponsor
|
| Name |
KAHER Institute of Physiotherapy |
| Address |
KAHER Institute of Physiotherapy, JNMC Campus, Nehru Nagar,
Belagavi-590010
|
| Type of Sponsor |
Research institution and hospital |
|
|
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 Sanjana Pammannavar |
KAHER Institute of Physiotherapy |
Advanced
Physiotherapy centre
OPD NO.39 department
of pediatric
physiotherapy room
no.21 sagar floor
Belgaum
KARNATAKA Belgaum KARNATAKA |
9380358281
sanjanapammannavar@klekipt.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC KLE ACADEMY OF HIGHER EDUCATIOM ANND RESEARCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
athletes having dysmenorrhea |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
dry cupping therapy |
dry cupping therapy will be given for first 3days of menstrual cycle for 3 consecutive months (at abdomen pr lowback) |
| Comparator Agent |
hot moist pack |
hot most pack will be given for 15min on abdomen or low back for first 3 days of menstrual cycle for 3 consecutive months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Female |
| Details |
Female athletes [nulliparous)
Training commitment for 3 or more organized sessions weekly (for more than150 minutes structured sport participation)
Regular menstrual cycles with confirmed primary dysmenorrhea history
Pain intensity, On activity more than5, At rest more than 3 on VAS
Willingness to abstain from analgesic medications more than 6 hours prior to testing
Provision of written informed consent
Andreson and Milsom grade more than grade 2
|
|
| ExclusionCriteria |
| Details |
Secondary dysmenorrhea conditions (endometriosis pelvic pathology)
Pregnancy or breastfeeding status
Bleeding disorders anticoagulant therapy or skin infections at potential cupping sites
Cardiovascular or neurological disorders
Medications affecting heart rate parameters
Contraindications to dry cupping therapy and hot moist pack
Inability to maintain supine/prone positioning for 30-40 minutes
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
VAS [visual analogue scale] pain intensity rating and Andreson and Milsom grade
|
VAS [visual analogue scale] pain intensity rating and Andreson and Milsom grade will be taken before and after the intervention that is at day 1 of start of the intervention and after 3 months once the intervention is over
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Resting heart rate |
Resting heart rate 60-second measurement wil be taken for each participant before anf after the intervention
|
Blood pressure
|
Blood pressure (average of 2 readings) will be taken before nad after the intervention |
| pulse rate |
will be measure before and after the intervention |
| Menstrual distress questionnaire [MCQ] |
will be taken before and after the intervention , it has 3 sections and will be scored out of 78 as mild, moderate and severe distress |
| Perceived performance scale |
will be taken before and after the intervention |
| Simple Attendance Log |
will be taken before and after the intervention |
|
|
Target Sample Size
|
Total Sample Size="56" Sample Size from India="56"
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)
|
12/11/2025 |
| 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="5" 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 - NO
|
|
Brief Summary
|
The title of the study is comparative study of dry cupping and hot moist pack on primary dysmenorrhea and cardiovascular parameters in female athletes. This study focuses on evaluating and comparing the effectiveness of dry cupping and hot moist pack in reducing menstrual pain (primary dysmenorrhea) and improving cardiovascular parameters (resting heart rate and blood pressure) among female athletes aged 18 to 30 years who are nulliparous. Primary dysmenorrhea is one of the most common menstrual disorders, characterized by painful uterine cramps in the absence of pelvic pathology. It is caused mainly by an increased production of prostaglandins, leading to uterine muscle contractions, ischemia, and pain. In athletes, these symptoms often result in decreased training performance, fatigue, and absenteeism from sports activities. Conventional treatment options like NSAIDs and hormonal contraceptives are effective but can cause side effects such as gastrointestinal discomfort, headaches, and drowsiness. Therefore, non pharmacological therapies such as heat application and cupping therapy are gaining attention for being safe, cost effective and drug free alternatives. Although dry cupping therapy has shown promising results for pain relief in general populations, there is limited research on its application specifically in female athletes. Athletes require fast and effective interventions that allow them to continue training without dependence on medication. Hot moist pack provide short-term relief but do not address the root cause of pain. Dry cupping through suction-induced negative pressure, may enhance blood circulation, reduce muscle tension and aid in faster recovery from pain. Hence, this study aims to generate scientific evidence comparing both techniques for menstrual pain management in athletes. this is a randomized clinical study done on age group of 18 to 30 years nulliparous female athletes with primary dysmenorrhea. the study is done on 56 participants with duration of 6 months in belagavi community and reginal sports club. The intervention given is two groups GROUP A dry cupping is given where it is applied to the lower abdomen/lumbosacral area for 15 minutes daily during the first 3 days of menstruation for three consecutive cycles. For GROUP B hot moist pack is given with the same schedule and duration, using moist heat applied to the same area. The primary outcome measure is visual analogue scale and andersch and milsom grading for pain where as secondary outcome are resting heart rate, blood pressure, pulse rate, attendance log, perceived performance scale, menstrual distress questionnaire. The expected outcome should be that dry cupping therapy provides greater and long lasting relief from dysmenorrhea compared to hot moist packs. Additionally, cupping may positively influence cardiovascular recovery during menstruation, reflected by improved resting heart rate and blood pressure regulation. this study bridges the gap between traditional therapeutic methods and modern sports physiotherapy, aiming to establish dry cupping as a safe, effective. and evidence based intervention for menstrual pain management in female athletes. |