| CTRI Number |
CTRI/2025/07/090718 [Registered on: 11/07/2025] Trial Registered Prospectively |
| Last Modified On: |
10/07/2025 |
| 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
|
Comparing Core Strengthening and Pilates Exercises for People with Low Back Pain |
|
Scientific Title of Study
|
Efficacy of Core Strengthening Exercise versus Pilates Exercise for Mechanical 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 |
Mohammad Ramiz Uddin |
| Designation |
Undergraduate student |
| Affiliation |
Jashore University of Science and Technology |
| Address |
Room No: 304, Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology
7408 Other |
| Phone |
8801876246767 |
| Fax |
|
| Email |
ramij6266@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Md Feroz Kabir |
| Designation |
Assistant Professor |
| Affiliation |
Jashore University of Science and Technology |
| Address |
Room No: 409, Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology
7408 Other |
| Phone |
8801765932545 |
| Fax |
|
| Email |
feroz@just.edu.bd |
|
Details of Contact Person Public Query
|
| Name |
Dr Md Feroz Kabir |
| Designation |
Assistant Professor |
| Affiliation |
Jashore University of Science and Technology |
| Address |
Room No: 409, Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology
7408 Other |
| Phone |
8801765932545 |
| Fax |
|
| Email |
feroz@just.edu.bd |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology, Jashore-7408, Bangladesh |
| Department of Physiotherapy and Rehabilitation,Jashore University of Science and Technology (JUST),Jashore-7408
Khulna Division, Bangladesh
Pincode: 7408
Country: Bangladesh |
|
|
Primary Sponsor
|
| Name |
Department of Physiotherapy and Rehabilitation |
| Address |
Department of Physiotherapy and Rehabilitation, Jashore
University of Science and Technology, Jashore-7408, Bangladesh |
| Type of Sponsor |
Other [University ] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Bangladesh |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Md Kabir Hossain |
Dr M R Khan Medical Center |
Level-3,Room:301,Musculoskeletal Lab,Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology,Jashore -7408
|
880178315139
kabir2002pt@gmail.com |
| Dr Md Kabir Hossain |
Dr. M R Khan Medical Center, room no: 301, Musculoskeletal Lab, Department of PTR, JUST |
Jashore, Bangladesh
|
880178315139
kabir2002pt@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IRB of Department of Physiotherapy and Rehabilitation, JUST |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M959||Acquired deformity of musculoskeletal system, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Core Strengthening |
Warm-Up and Cool-Down Protocol
Each session will include the following:
- Warm-up: 5–10 minutes of light aerobic activity (e.g., walking, stationary cycling) and dynamic stretching.
- Cool-down: 5 minutes of light stretching and breathing exercises to promote relaxation and recovery.
Week 1–2 - ADIM with PBU (10 sec × 10 reps × 3 sets), Modified Plank with TA Activation (3 sets × 30 sec), Side Bridge (Modified) (3 sets × 30 sec)
Week 3–4 - Same as Week 1–2, increase hold time by 5 sec or reps by 2 if tolerated,
Week 5–6 - Same exercises with progressive overload: ADIM hold 15 sec, more reps/sets as tolerated
frequency - 3 sessions/week |
| Comparator Agent |
Pilates Exercise |
Warm-Up and Cool-Down Protocol Each session will include the following: - Warm-up: 5–10 minutes of light aerobic activity (e.g., walking, stationary cycling) and dynamic stretching. - Cool-down: 5 minutes of light stretching and breathing exercises to promote relaxation and recovery. Week 1–2 - Leg Pull Front (3 sets × 10 reps, 5–10 sec hold), Side-Lying Leg Circles (2–3 sets × 8–10 reps), Single Leg Stretch (3 sets × 10–12 reps) Week 3–4 - Same as Week 1–2, add 1 more set if tolerated Week 5–6 - Pilates: hold positions longer (10–15 sec), add 1–2 reps/sets frequency - 3 sessions/week |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
01.NSLBP for at least 3 months
02.Experienced a pain intensity of 3 or higher based on the visual
analogue scale (VAS, 0-10)
03. All male and female adults between age group of 20–60 years
04. Subjects willing to participate in the study.
|
|
| ExclusionCriteria |
| Details |
01.History of spinal surgery
02.History of ankylosing spondylitis or rheumatoid arthritis
03.History of spondylolisthesis or spondylolysis
04.History of spinal or pelvic fracture
05.History of spinal inflammation or tumor
06. History of osteoporosis.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Core Strength: Pressure Biofeedback |
at baseline, 6 weeks and 18 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Pain(VAS)
Functional Disability (ODI)
Quality of life(SF-36) |
at baseline, 6 weeks and 18 weeks |
|
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="0"
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)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
26/07/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0" Months="4" Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Applicable |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [feroz@just.edu.bd].
- For how long will this data be available start date provided 01-01-2026 and end date provided 01-01-2030?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This study aims to compare the effects of core strengthening exercises and Pilates exercises on individuals with mechanical low back pain. Participants aged between 20 and 60 years, experiencing non-specific low back pain for at least 3 months and reporting a pain level of 3 or higher on the Visual Analogue Scale (VAS), will be included. The study will be conducted as a randomized clinical trial at the Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology. Participants will be randomly assigned to either a core strengthening group or a Pilates exercise group. The interventions will be delivered by qualified physiotherapists. The primary outcome measure will be core strength assessed by pressure biofeedback. Secondary outcomes include pain, functional disability, and quality of life measured using validated tools. The study follows the CONSORT reporting guideline and is partially funded by the Department of Physiotherapy and Rehabilitation at JUST |