| CTRI Number |
CTRI/2026/02/105055 [Registered on: 27/02/2026] Trial Registered Prospectively |
| Last Modified On: |
26/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Effectiveness of Pilates in Back Strength and Pain in Adults with Chronic Back Issues |
|
Scientific Title of Study
|
Effect of Pilates on Lower Back Endurance and Perception of change among Adults with Persistent Lower Back Pain : A Pilot Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Krishna Reddy Vajrala |
| Designation |
Associate Professor |
| Affiliation |
Galgotias University |
| Address |
Room No B312 Department of Physiotherapy School of Allied and Health Sciences Galgotias University Plot No 2, Sector 17A Opposite Buddha International Circuit G Greater Noida India
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
7799233734 |
| Fax |
|
| Email |
krishnareddympt@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Tanya |
| Designation |
Student |
| Affiliation |
Galgotias University |
| Address |
Room No E005 Department of Physiotherapy School of Allied and Health Sciences Galgotias University Sector 17 A Opposite Buddha International Circuit, Greater Noida India
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
7667052699 |
| Fax |
|
| Email |
dr.tanya247@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Tanya |
| Designation |
Student |
| Affiliation |
Galgotias University |
| Address |
Room No E005 Department of Physiotherapy School of Allied and Health Sciences Galgotias University Sector 17 A Opposite Buddha International Circuit, Greater Noida India
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
7667052699 |
| Fax |
|
| Email |
dr.tanya247@gmail.com |
|
|
Source of Monetary or Material Support
|
| Research and Development Cell, Galgotias University Plot No 2, Sector 17 A , Opposite Buddha International Circuit, Greater Noida India 203201 |
|
|
Primary Sponsor
|
| Name |
Galgotias University Greater Noida |
| Address |
Room No C113, Galgotias University Plot No 2, Sector 17 A , Opposite Buddha International Circuit, Greater Noida 203201 |
| Type of Sponsor |
Research institution |
|
|
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 |
| Tanya |
GALGOTIAS UNIVERSITY |
Room No E005 Department of Physiotherapy School of Allied and Health Sciences
Gautam Buddha Nagar
UTTAR PRADESH |
7667052699
dr.tanya247@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Departmental Research Committee,Galgotias University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M999||Biomechanical lesion, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
General physical activity |
The control group received only general physical activity guidance, which included advice to remain active and avoid prolonged periods of rest but did not involve any structured exercise intervention. |
| Intervention |
Pilates
|
The Pilates group underwent supervised sessions conducted three times per week for six weeks, each lasting approximately 45 minutes, focusing on core stabilization, pelvic-lumbar control, breathing coordination, and progressive activation of deep trunk musculature. Exercises included mat-based movements such as the pelvic tilt, bridge, hundred, spine stretch, and single leg stretch, progressively modified based on participant capability and tolerance. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Age : Adults (25-50 years)
Sex: All genders
Duration : Chronic condition (more than 3 months)
Able to engage and participate in the study
|
|
| ExclusionCriteria |
| Details |
Acute low back pain (within the past 3 months).
H/o spinal surgery
Trauma or Injury
Spondylolisthesis
Neurological disorders that impair balance or mobility.
Pregnancy or any condition that precludes Pilates or physical activity.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Sorensen Test (for back muscle endurance)
Visual Analog Scale (VAS)
Oswestry Disability Index (ODI)
Patient Global Impression of Change (PGIC) |
Baseline and after 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| SF36 |
4 weeks |
|
|
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 1 |
|
Date of First Enrollment (India)
|
15/03/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/03/2026 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="15" |
|
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
|
In this pilot study that compared two interventions for persistent low back pain, participants are designated to two groups. Participants were randomly assigned to either a Pilates group (n = 15) receiving supervised Pilates sessions three times per week for 6 weeks or a control group (n = 15) receiving only general activity guidance. Outcome measures included the Sorensen Test (for back muscle endurance), Visual Analog Scale (VAS), Oswestry Disability Index (ODI), and Patient Global Impression of Change (PGIC). The Pilates group will do guided alignment motions, focusing on the strengthening of the core muscles and spine, In comparison, the control group received just general physical activity recommendations, such as staying active and avoiding long periods of rest, but no formal exercise intervention. Data analysis will be done descriptively to summarize group characteristics. |