| CTRI Number |
CTRI/2024/03/063655 [Registered on: 06/03/2024] Trial Registered Prospectively |
| Last Modified On: |
05/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Exercise to relieve back pain in menopausal women by using core and pelvic |
|
Scientific Title of Study
|
Additional effect of pelvic floor exercise with core stability exercises in non specific low back pain among menopausal 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 |
Midhat Shafa |
| Designation |
Student |
| Affiliation |
Amity insitute of allied health sciences |
| Address |
F-1 107,Amity institute of health allied sciences, Amity University,sector 125 Noida Uttar Pradesh 201301
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Phone |
8800134739 |
| Fax |
|
| Email |
midhatshifa115@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Pankaj Kumar Malik |
| Designation |
Assistant Professor |
| Affiliation |
Amity institute of allied health sciences |
| Address |
F-1 107, Amity institute of health allied sciences, Amity University, sector 125 Noida Uttar Pradesh 201301
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Phone |
9899274238 |
| Fax |
|
| Email |
pkmalik@amity.edu |
|
Details of Contact Person
Public Query
|
| Name |
Asad Manzoor |
| Designation |
HOD |
| Affiliation |
Health plus physio and rehab centre |
| Address |
C-273/4,40 foota Road, near Bilal Masjid, Shaheen Bagh, Okhla, New Delhi, Delhi, 110025
South
DELHI
110025
India |
| Phone |
9910455008 |
| Fax |
|
| Email |
asad786manzoor@gmail.com |
|
|
Source of Monetary or Material Support
|
| Health plus physio and rehab center C-273/4,40 foota Road, near Bilal Masjid, Shaheen Bagh, Okhla, New Delhi, Delhi, 110025 |
|
|
Primary Sponsor
|
| Name |
Midhat Shafa |
| Address |
Amity institute of healrh allied sciences,Amity university, F-1 107,Sector 125 Noida Uttar Pradesh 201301 |
| 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 Asad Manzoor |
Health plus physio and rehab centre |
C-273/4, Ground Floor, 40, foota Road, near Bilal Masjid, Shaheen Bagh, Okhla, New Delhi, Delhi, 110025
South
DELHI |
9910455008
asad786manzoor@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Amity University Noida, NTCC committee |
Approved |
| Amity University Noida, NTCC committee |
No Objection Certificate |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M545||Low back pain, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
only core |
group A exercises were designed 10 sets, 5 repetitions. Rest intervals were set as 10 seconds between the sets and 2 mins between the exercises. This group will receive core stability exercises and pelvic floor exercise to check the effect in reducing low back pain |
| Comparator Agent |
pelvic and core |
group B exercises were designed 10 sets, 5 repetitions. rest intervals were set as 10 seconds between the sets and 2 min between the exercises.this group will receive pelvic floor exercise and core stability exercise. |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
Currently seeking physiotherapy treatment for back pain,
Able to participate in moderate physical activities
, Willing to comply with the exercise regimen and attend
scheduled sessions, Capable of providing informed consent for study participation. |
|
| ExclusionCriteria |
| Details |
Exclusion criteria include individuals with the following conditions: a history of spinal surgery, rheumatological spine disorders, severe spinal pathologies, spinal deformities, or spinal tumrs; recent low extremity injuries; endocrine or neuromuscular conditions; arthritis or orthopedic disorders; orthostatic hypotension; visual impairments; vestibular system issues; or any physical injury affecting balance. Additionally, participants using psychoactive or
antihypertensive medications (such as antidepressants, antipsychotics,
sedatives/hypnotics, antiepileptics, or antiparkinsonian drugs) are also excluded. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| pain reduction, core stability |
baseline, week 2 and after week 4 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| impact of exercise on their overall back pain |
after week 4 |
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
14/03/2024 |
| 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="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
|
To check the additional Effect of Pelvic Floor Exercises with Core Stability exercises in Non Specific Low Back Pain Among Menopausal Women. There will two group in which one will receive core stability exercise and pelvic floor exercise and other group will receive pelvic floor only.exercises were designed 10 sets, 5 repetitions. Rest intervals were set as 10 seconds between the sets and 2 mins between the exercises. |