| CTRI Number |
CTRI/2025/09/095170 [Registered on: 22/09/2025] Trial Registered Prospectively |
| Last Modified On: |
20/09/2025 |
| 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
|
Effect of pelvic exercises on low back pain and muscle fatigue in menstruating women. |
|
Scientific Title of Study
|
Effectiveness of pelvic and lower extremity diagonal Proprioceptive Neuromuscular Facilitation (PNF) patterns on low back pain and muscle fatigue in menstruating women. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Harshdeep kaur |
| Designation |
Post graduate student |
| Affiliation |
Guru Nanak Dev University |
| Address |
Department of Physiotherapy, Guru Nanak Dev University, Amritsar 143005
Department of Physiotherapy, Guru Nanak Dev University, Amritsar 143005
Amritsar
PUNJAB
143005
India |
| Phone |
9876707279 |
| Fax |
|
| Email |
harshdeepsadaal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Poonam Chaturvedi |
| Designation |
Assistant Professor |
| Affiliation |
Guru Nanak Dev University |
| Address |
Department of Physiotherapy, Guru Nanak Dev University, Amritsar 143005
Department of Physiotherapy, Guru Nanak Dev University, Amritsar 143005
Amritsar
PUNJAB
143005
India |
| Phone |
9920878156 |
| Fax |
|
| Email |
hsood96@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Harshdeep kaur |
| Designation |
Post graduate student |
| Affiliation |
Guru Nanak Dev University |
| Address |
Department of Physiotherapy, Guru Nanak Dev University, Amritsar 143005
Department of Physiotherapy, Guru Nanak Dev University, Amritsar 143005
Amritsar
PUNJAB
143005
India |
| Phone |
9876707279 |
| Fax |
|
| Email |
harshdeepsadaal@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Harshdeep kaur |
| Address |
Gali shaheed Mangal Singh Wali, Nurdi Adda, Tarn Taran, Punjab |
| Type of Sponsor |
Other [self funded] |
|
|
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 |
| Hardika Sood |
Guru Nanak Dev University |
Health center ,Guru Nanak Dev University, Amritsar
Amritsar
PUNJAB |
9920878156
hsood96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Guru Nanak Dev University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
menstruating women |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Heat therapy and PROPRIOCEPTIVE NEUROMUSCULAR FACILITATION |
Moist heat pack therapy will be given to the participants on the lower back area during menstrual cycle and after the cycle ends, pelvic and lower extremity diagonal proprioceptive neuromuscular facilitation pattern exercises will be given to the participants of experimental group for the duration of 4 weeks, twice a week. |
| Comparator Agent |
heat therapy and range of motion exercises |
Moist heat pack therapy will be given to the participants on the lower back area during menstrual cycle and after the cycle ends, pelvic and lower extremity range of motion exercises will be given to the participants of control group for the duration of 4 weeks, twice a week. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Female |
| Details |
Back pain in women during menstruation
muscle fatigue during menstruation
|
|
| ExclusionCriteria |
| Details |
History of polycystic ovary syndrome
any history of spine and pelvic surgery
any history of spinal injury and trauma
history of lumbar disc herniation
history of pelvic inflammatory diseases
history of spinal deformities
history of lower limb surgeries |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Numerical pain rating scale
Borg scale of perceived exertion
WaLIDD scale for dysmenorrhea |
baseline and after 4 weeks of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
06/10/2025 |
| 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="8"
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
|
Primary purpose of the study - To evaluate the effectiveness of Pelvic and Lower Extremity Diagonal Proprioceptive
Neuromuscular Facilitation (PNF) Patterns in Alleviating Low Back Pain and Muscle
Fatigue in Menstruating Women
OBJECTIVES OF THE STUDY
1. To investigate the effectiveness of pelvic and lower extremity diagonal PNF patterns
in reducing low back pain during menstruation. 2. To assess the impact of these PNF patterns on muscle fatigue in menstruating
women 3. To compare the efficacy of pelvic and lower extremity diagonal PNF patterns with
conventional method (hot pack and medication taking) in menstruating women .
HYPOTHESES
Alternative Hypothesis: Pelvic and lower extremity diagonal PNF patterns will
significantly reduce low back pain and muscle fatigue in menstruating women.
Null Hypothesis : Pelvic and lower extremity diagonal PNF patterns will not
effective than conventional exercises in alleviating low back pain and muscle fatigue. |