| CTRI Number |
CTRI/2025/03/081721 [Registered on: 05/03/2025] Trial Registered Prospectively |
| Last Modified On: |
27/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Various Exercises on Lumbar Hyperlordosis |
|
Scientific Title of Study
|
Effect of Core Strengthening, Mckenzie and Williams Flexion Exercises on Lumbar Hyperlordosis in Females with Low Back Pain |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prabhjot Kaur |
| Designation |
Masters of Physiotherapy Student |
| Affiliation |
Guru Nanak Dev University |
| Address |
Department Of Physiotherapy, Guru Nanak Dev University, Amritsar, Punjab, India
Amritsar
PUNJAB
143005
India
Amritsar
PUNJAB
143005
India |
| Phone |
7087047670 |
| Fax |
|
| Email |
prabhjotgogia123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Maman Paul |
| Designation |
Assistant Professor |
| Affiliation |
Guru Nanak Dev University |
| Address |
Department Of Physiotherapy, Guru Nanak Dev University, Amritsar, Punjab, India
Amritsar
PUNJAB
143005
India
Amritsar
PUNJAB
143005
India |
| Phone |
9815459353 |
| Fax |
|
| Email |
mamanpaul@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Maman Paul |
| Designation |
Assistant Professor |
| Affiliation |
Guru Nanak Dev University |
| Address |
Department Of Physiotherapy, Guru Nanak Dev University, Amritsar, Punjab, India
Amritsar
PUNJAB
143005
India
Amritsar
PUNJAB
143005
India |
| Phone |
9815459353 |
| Fax |
|
| Email |
mamanpaul@gmail.com |
|
|
Source of Monetary or Material Support
|
| Guru Nanak Dev University, Amritsar-143005, Punjab, India. |
|
|
Primary Sponsor
|
| Name |
Prabhjot Kaur |
| Address |
Department Of Physiotherapy, Guru Nanak Dev University, Amritsar-143005, Punjab, India. |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Maman Paul |
Assistant Professor, Department Of Physiotherapy, Guru Nanak Dev University, Amritsar, Punjab, India |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Maman Paul |
Guru Nanak Dev University |
Department of Physiotherapy, Guru Nanak Dev University, Amritsar-143005, Punjab, India
Amritsar
PUNJAB |
9815459353
mamanpaul@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Guru Nanak Dev University,Amritsar-143005, Punjab, India (Established by the State Legislature Act No. 21 of 1969) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Core Strengthening Exercise (CSE),
McKenzie Exercise(ME) and
Williams Flexion Exercise(WFE) |
Core Strengthening Exercise that is Extended child pose, Kneeling lunge, Bridging, Abdominal pulse ups, Side plank and plank.
McKenzie Exercise that is Cat and Camel exercise, Rectus femoris stretch(in kneeling position),Knee To Chest exercises, Posterior Pelvic tilt Exercise(standing against the wall) ,Static Abdomen (crook lying) and Gluteal Activation (Prone lying). William’s Flexion Exercise that is Pelvic tilt, Single knee to chest, double knee to chest, Partial Sit up, Hamstring Stretch, Hip flexor Stretch |
| Comparator Agent |
Core Strengthening Exercise (CSE),
McKenzie Exercise(ME) and Williams Flexion Exercise(WFE) |
No Control group; a direct comparison is made between CSE, ME and WFE |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
27.00 Year(s) |
| Gender |
Female |
| Details |
1. Age 18-27 years
2. Young females
3. Lumbar Hyperlordosis (angle more than 45 degree)
4. The subjects with non specific low back pain (more than 12 weeks) |
|
| ExclusionCriteria |
| Details |
1.Subject with any congenital or acquired spinal deformities
2. Subject with history of spinal fracture
3. Pregnant females
4. Presence of spondylolisthesis
5. History of disc protrusion
6. Scoliosis
7. Subject who are physical disabled
8. Psychological disorder |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Visual analog scale (VAS)
2.Modified Oswestry Disability Questionnaire
3. Lumbar lordosis measured using a flexible ruler
4. Lumbar flexibility
5. Static Balance - One leg stand test
6. Dynamic Balance -Y balance test |
Outcome Variable will be assessed baseline and after 5 weeks for all 3 intervention groups |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| N/A |
N/A |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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)
|
10/03/2025 |
| 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="1"
Days="5" |
|
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
|
This study titled "Effect of Core Strengthening, Mckenzie and William’s Flexion Exercises on Lumbar Hyperlordosis in Females with Low Back Pain" consisted of participants aged 18-27 years females. This experimental study will consists of 75 participants, divided into 3 groups: Core strengthening exercises (CSE), Mckenzie Exercises (ME) and William’s Flexion Exercises (WFE). The protocol was of 5 weeks, four days a week and the following outcome measures were used: Flexible ruler to assess the lumbar lordosis , Visual Analogue scale for pain , Modified Schober to assess the spinal motion , One Leg Stand Test to assess static balance , Y-Balance test to assess dynamic balance and Modified Oswestry Disability Questionnaire for low back pain related disability .The study aims to explore the benefits of three types of exercises on above mentioned variables. |