| CTRI Number |
CTRI/2025/07/090483 [Registered on: 08/07/2025] Trial Registered Prospectively |
| Last Modified On: |
10/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study to See if Tummy and back muscle exercises Can Help Reduce Period Pain in Girls Aged 12 to 18 Years |
|
Scientific Title of Study
|
EFFECT OF CORE STRENGTHENING EXERCISES ON PAIN IN ADOLESCENTS AGED 12-18 YEARS WITH PRIMARY DYSMENORRHEA |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
S P Prajna Prabha |
| Designation |
Post Graduate |
| Affiliation |
Dr. D.Y. Patil College Of Physiotherapy |
| Address |
Room no A40 carnation old girls hostel sant tukaram Nagar near dr DY PATIL Vidyapeeth Pimpri
Pune
MAHARASHTRA
411018
India |
| Phone |
8249920130 |
| Fax |
|
| Email |
spprabha845@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sanjivani Nikhil Kamble |
| Designation |
Associate Professor |
| Affiliation |
Dr. D. Y. Patil College of Physiotherapy |
| Address |
Dr. D. Y. Patil College of Physiotherapy, Sant Tukaram Nagar, Pimpri, Pune-411018
Maharashtra, India
Dr.DY PATIL VIDYAPEETH
Pune
MAHARASHTRA
411018
India |
| Phone |
9860117191 |
| Fax |
|
| Email |
sanjivani.dhote@dpu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Sanjivani Nikhil Kamble |
| Designation |
Associate Professor |
| Affiliation |
Dr. D. Y. Patil College of Physiotherapy |
| Address |
Dr. D. Y. Patil College of Physiotherapy, Sant Tukaram Nagar, Pimpri, Pune-411018
Maharashtra, India
Dr.DY PATIL VIDYAPEETH
Pune
MAHARASHTRA
411018
India |
| Phone |
9860117191 |
| Fax |
|
| Email |
sanjivani.dhote@dpu.edu.in |
|
|
Source of Monetary or Material Support
|
| DR. D.Y. PATIL COLLEGE OF PHYSIOTHERAPY, PIMPRI, PUNE |
|
|
Primary Sponsor
|
| Name |
S P Prajna Prabha |
| Address |
Dr. D. Y. Patil Public School, sant tukaram nagar, pimpri, pune-411018 |
| Type of Sponsor |
Other [self] |
|
|
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 Sanjivani Nikhil kamble |
Dr. D. Y. Patil Public School |
Dr. D. Y. Patil Public School,
Sant Tukaram Nagar,
Pimpri, Pune - 411 018,
Maharashtra, India
Pune
MAHARASHTRA |
9860117191
sanjivani.dhote@dpu.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
ADOLESCENTS 12 TO 18 YEARS HAVING PRIMARY DYSMENORRHEA |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
conventional treatment |
proper patient education and advice related to dysmenorrhea |
| Intervention |
CORE STRENGTHENING EXERCISES AND CONVENTIONAL TREATMENT |
participant will undergo a 4 week intervention which includes core strengthening exercises of 2 sets of 10-40 repetitions followed by proper patient education advice related to dysmenorrhea |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Female |
| Details |
1. Persistent primary dysmenorrhea for more than 6 months with VMSS 2,1, and 0.
2. Subjects willing to participate in the study
3. No history of irregular menstrual bleeding from 21-35 days and lasting from 3-7 days
4. Free from any gynecological problems like PCOD
5. Female adolescents having poor core strength with SCST levels 1, 2, and 4. |
|
| ExclusionCriteria |
| Details |
1. Female adolescents who cannot tolerate the exercises
2. Female adolescents taking any medication leading to irregular cycles
3. Female adolescents having a history of any surgery or trauma. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| WALIDD SCORE |
WEEK 0 AND WEEK 4 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. pediatric quality of life (PEDS-QOL) |
week 0 and week 4 |
| SCST |
WEEK 0 AND WEEK 4 |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
18/07/2025 |
| Date of Study Completion (India) |
09/01/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
09/01/2026 |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
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 - NO
|
|
Brief Summary
|
Dysmenorrhea is the most frequent gynaecological disorder, with around 20-90% of women suffering from this problem during their reproductive years. According to studies, dysmenorrhea is the largest cause of recurring short-term school absence in adolescent girls, with the prevalence of primary dysmenorrhea ranging from 16% to as high as 93%. Women with primary dysmenorrhea feel intense, intermittent spasmodic pain in the suprapubic area. Dysmenorrhea can cause pain in the back of the legs or lower back, as well as mood changes, lethargy, headache, nausea, and oedema during periods. Dysmenorrhea can lead to negative repercussions such as decreased quality of life, emotional disorders, sleep disturbances, and limited daily activities. This study investigates the effectiveness of core strengthening exercises in reducing menstrual pain and improving quality of life among adolescent girls aged 12 to 18 years diagnosed with primary dysmenorrhea. Participants will be randomly divided into two groups. Group A will undergo a structured core strengthening exercise protocol, while Group B will receive conventional lifestyle and pain management advice. Pain severity, quality of life, and core stability will be assessed using the WaLIDD Score, Pediatric Quality of Life Inventory (PedsQL), and Sahrmann Core Stability Test, respectively. The intervention will last for four weeks with pre- and post-intervention assessments. METHODOLOGY:- | STUDY DESIGN : |
| Experimental Study Design (Randomized Parallel Group Trial) | | STUDY SETTING : | | Dr. D. Y. Patil College of Physiotherapy, Pimpri, Pune | | TARGET POPULATION: | | Adolescent females with primary dysmenorrhea | | SAMPLE POPULATION: | | Females aged 12–18 years | | SAMPLING METHOD: | | Convenient Sampling | | SAMPLING DESIGN: | | Random allocation into two parallel groups (Core Exercise vs. Conventional) | | SAMPLE SIZE: | | 60 participants | The study will be conducted at Dr. D.Y. Patil Public School, Pimpri, Pune, following approval from the academic committee. Participants will be selected based on inclusion criteria and exclusion criteria, and informed written consent will be obtained. The procedure and interventions will be explained in detail with time allotted for any questions. Participants will be randomly divided into two groups: Group A—Core Strengthening Exercise Group: Participants will perform a structured core strengthening program for 4 weeks, 5 days per week. Exercises will include mat-based and Swiss ball-based activities, progressing weekly in intensity and complexity. Sessions include a 5-minute warm-up, 30 minutes of core exercises (e.g., pelvic bridging, curl-ups, planks, Swiss ball crunches), and a 5-minute cool-down. The goal is to improve core muscle strength and stability to reduce dysmenorrhea-related pain. Group B—Control Group (Conventional Treatment): Treatment): Participants will receive education and advice regarding lifestyle modifications, dietary recommendations, hydration, proper sleep, stress management, and pain-relief strategies such as heat therapy and the use of NSAIDs when necessary. No physical exercise program will be administered. Both groups will be assessed pre- and post-intervention using WaLIDD Score (pain severity), PedsQL (quality of life), and Sahrmann Core Stability Test (core muscle function). The entire protocol will continue for 4 weeks with sessions scheduled at approximately the same time for 3 days per week. |