| CTRI Number |
CTRI/2022/02/040111 [Registered on: 08/02/2022] Trial Registered Prospectively |
| Last Modified On: |
22/02/2022 |
| 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
|
Effects of core stabilization and hip exercises on pain, disability and muscle endurance in patients with non specific low back pain. |
|
Scientific Title of Study
|
Effectiveness of Hip muscle Stretching, Strengthening along with Core stabilization exercises on pain, disability and muscle endurance in patients with Non Specific low back pain. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nimra Nasir |
| Designation |
Post graduate student |
| Affiliation |
Amity Institute Of Physiotherapy |
| Address |
LGF, F1 Block, Amity Istitute of Physiotherapy, Amity University, Sector 125, Noida, Uttar Pradesh
LGF, F1 Block, Amity Istitute of Physiotherapy, Amity University, Sector 125, Noida, Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
201303
India |
| Phone |
9458726212 |
| Fax |
- |
| Email |
nimranasir714@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nimra Nasir |
| Designation |
Post graduate student |
| Affiliation |
Amity Institute Of Physiotherapy |
| Address |
LGF, F1 Block, Amity Istitute of Physiotherapy, Amity University, Sector 125, Noida, Uttar Pradesh
LGF, F1 Block, Amity Istitute of Physiotherapy, Amity University, Sector 125, Noida, Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
201303
India |
| Phone |
9458726212 |
| Fax |
- |
| Email |
nimranasir714@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nimra Nasir |
| Designation |
Post graduate student |
| Affiliation |
Amity Institute Of Physiotherapy |
| Address |
LGF, F1 Block, Amity Istitute of Physiotherapy, Amity University, Sector 125, Noida, Uttar Pradesh
LGF, F1 Block, Amity Istitute of Physiotherapy, Amity University, Sector 125, Noida, Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
201303
India |
| Phone |
9458726212 |
| Fax |
- |
| Email |
nimranasir714@gmail.com |
|
|
Source of Monetary or Material Support
|
| Amity Institute of Physiotherapy |
|
|
Primary Sponsor
|
| Name |
None |
| Address |
None |
| Type of Sponsor |
Other [No Sponsor] |
|
|
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 Ruchi Varshney |
Ruchis Advanced Physiotherapy and Wellness |
111- B, Pocket 1, Mayur Vihar, New Delhi, 110091
New Delhi
DELHI |
9811843602
-
drruchivarshney@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Amity Institute of Physiotherapy |
Approved |
| Ruchis Advanced Physiotherapy & Wellness |
Approved |
|
|
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 |
| Comparator Agent |
Core stabilization exercises. |
For each exercise, isometric contraction will be maintained for 7-8 seconds. Each exercise will be repeated 10 times with 3 second rest between repetitions. |
| Intervention |
Hip muscle stretching, Hip strengthening exercises. |
Hip muscle stretching- All hip muscle stretch will be maintained for 30 seconds with 10 seconds rest in between. Exercises will be repeated 3 times and will be given 3 times per week.
Hip strengthening Exercises- Maximal isometric contraction will be maintained for 30 seconds before returning to original position with a rest of 10 seconds. Exercises will be repeated 3 times and will be given 3 times per week. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1.60 participants both male and female with non specific low back pain with duration 3 or more months.
2.Age group: 18-30 years.
3.Participants with minimum to moderate disability (upto 40%) on Oswestry disability index and pain intensity 1-6 on VAS. |
|
| ExclusionCriteria |
| Details |
Subjects diagnosed with-
1.Spondylosis, Spondylolisthesis and Ankylosing spondylosis.
2.Radiculopathy.
3.Spinal tumors.
4.Spinal Infection.
5.Previous spinal surgery.
6.Gynaecological problem or any other pathological condition.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain, disability |
0 week, second week, fourth week, follow up after 2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Muscle Endurance |
0 week, second week, fourth week, follow up after 2 weeks |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
14/02/2022 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Publication will be done after data collection and data analysis. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
General Assessment of the subjects will be performed to meet the inclusion criteria. Prior to the test , subjects will be informed about the procedure. Pre test low back pain, disability and muscle endurance will be assessed by ODI, VAS, DAET, DEET respectively. Scores will be recorded at the end of second and fourth week. Furthermore effectiveness of the exercises post treatment ( follow up ) period will also be recorded. Subjects will be instructed to do warm up exercises for 5 minutes, which consist of spot jogging. All the groups will be instructed to do exercises for 4 weeks with 3 days per week management.
Group A- Core stabilization exercises 1. Side bridge 2. Supine extension bridge 3. Straight leg raise from prone 4. Alternate arm and leg raise from quadruped 5. Prone bridge
For each exercise, isometric contraction will be maintained for 7-8 seconds. Each exercise will be repeated 10 times with 3 second rest between repetitions.
Group B- Hip muscle stetching + Core stabilization exercise 1. Hamstring stretch 2. Piriformis stretch 3. TFL stretch 4. Iliopsoas stretch 5. Side bridge 6. Supine extension bridge 7. Straight leg raise from prone 8. Alternate arm and leg raise from quadruped 9. Prone bridge
All hip muscle stretch will be maintained for 30 seconds with 10 second rest in between. Exercises will be repeated 3 times.
Group C- Hip strengthening exercises + Core stabilization exercises 1. Quadruped hip extension 2. Prone heel squeeze 3. Side lying hip Abduction 4. Standing Gluteal Squeeze 5. Side bridge 6. Supine extension bridge 7. Straight leg raise from prone 8. Alternate arm and leg raise from quadruped 9. Prone bridge
For strengthening exercises, maximal isometric contraction will be maintained for 30 second before returning to original position with a rest of 10 seconds. Each exercise will be repeated 3 times.
Post test scores will be recorded at the end of second and fourth week for each group using ODI and VAS. Scores will be assessed using ODI, VAS, DAET,DEET and will be compared. Data collection will be followed by data analysis. |