| CTRI Number |
CTRI/2025/05/086939 [Registered on: 14/05/2025] Trial Registered Prospectively |
| Last Modified On: |
13/05/2025 |
| 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
|
Effectiveness of Online Versus In-person Mat Pilates in Patients With Acute Non-Specific Low Back Pain |
|
Scientific Title of Study
|
Comparison of Tele rehabilitation versus Conventional Mode of Mat Pilates in the Management of individuals with Acute Non-Specific 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 |
Mr. Rajkumar M |
| Designation |
Assistant Professor |
| Affiliation |
SRM College of Physiotherapy |
| Address |
PT-22 SRM College of Physiotherapy, SRM Medical College, Kattankulathur campus Chengalpattu district
Chennai
TAMIL NADU
NIL
Chennai
TAMIL NADU
603203
India |
| Phone |
7092022034 |
| Fax |
|
| Email |
rajkumam2@srmist.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Mr. Rajkumar M |
| Designation |
Assistant Professor |
| Affiliation |
SRM College of Physiotherapy |
| Address |
PT-22 SRM College of Physiotherapy, SRM Medical College, Kattankulathur campus Chengalpattu district
Chennai
TAMIL NADU
NIL
Chennai
TAMIL NADU
603203
India |
| Phone |
7092022034 |
| Fax |
|
| Email |
rajkumam2@srmist.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Mr. Rajkumar M |
| Designation |
Assistant Professor |
| Affiliation |
SRM College of Physiotherapy |
| Address |
PT-22 SRM College of Physiotherapy, SRM Medical College, Kattankulathur campus Chengalpattu district
Chennai
TAMIL NADU
NIL
Chennai
TAMIL NADU
603203
India |
| Phone |
7092022034 |
| Fax |
|
| Email |
rajkumam2@srmist.edu.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
SRM College of Physiotherapy |
| Address |
SRM College of Physiotherapy, SRM Medical College, Kattankulathur campus Chengalpattu district
Chennai
TAMIL NADU |
| Type of Sponsor |
Other [Self Funded] |
|
|
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 |
| Mr RAJKUMAR M |
SRM College of Physiotherapy |
PT-22 SRM College of Physiotherapy, SRM Medical College, Kattankulathur campus Chengalpattu district
Chennai
TAMIL NADU
Chennai
TAMIL NADU |
7092022034
rajkumam2@srmist.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM Institutional Ethics Committee |
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 |
Conventional mode of Mat Pilates |
The comparator intervention involves a conventional, in-person mat Pilates exercise program aimed at managing acute non-specific low back pain. Participants assigned to this group will attend supervised physiotherapy sessions conducted face-to-face at a designated clinical or physiotherapy setting. Each session will be led by a qualified physiotherapist and will follow a structured format including warm-up exercises, core strengthening routines, flexibility training, and a cool-down phase. The sessions will be held three times per week, each lasting approximately 35 minutes, over a total duration of two weeks. The exercises will be tailored to individual participant needs based on baseline assessments, and continuous supervision will be provided to ensure proper technique and safety. This intervention will be implemented as part of a non-randomized crossover study design. |
| Intervention |
Tele rehabilitation based Mat Pilates Program
|
The tele rehabilitation intervention consists of a structured mat Pilates exercise program specifically designed for individuals with acute non-specific low back pain. It will be delivered online through live video conferencing platforms such as Zoom or Google Meet. Participants will receive supervised sessions conducted by a qualified physiotherapist, three times per week, with each session lasting approximately 35 minutes, over a period of 2 weeks. The sessions will include a warm-up phase, core strengthening exercises, flexibility training, and a cool-down phase. The program will be individually tailored based on the participant’s initial assessment, and real-time feedback will be provided to ensure proper technique and safety. This intervention will be implemented as part of a non-randomized crossover study design. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Both male and female participants will be included.
Participants aged between 20 years and 40 years will be included.
Patients presenting with a Numerical Pain Rating Scale score of greater than or equal to 6 will be included.
Individuals diagnosed with acute non-specific low back pain of less than 6 weeks duration will be included.
Participants who are willing to take part in tele rehabilitation will be included.
Patients currently undergoing conventional physiotherapy interventions will be included.
Participants who have access to and are able to operate the necessary technology required for tele rehabilitation will be included.
|
|
| ExclusionCriteria |
| Details |
Individuals with chronic pain syndromes will be excluded.
Individuals who have undergone previous lumbar surgeries will be excluded.
Patients diagnosed with lumbar pathologies such as spondylosis, spondylitis, or spondylolisthesis will be excluded.
Patients currently undergoing alternative treatment protocols, for example ayurvedic and acupuncture will be excluded.
Patients with co-morbidities such as cardiovascular, respiratory, or metabolic conditions will be excluded.
Patients with chest and vertebral column deformities will be excluded.
Patients with psychiatric disorders, including depression and schizophrenia, will be excluded.
Pregnant women with low back pain symptoms will be excluded. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The Numerical Pain Rating Scale
The Roland-Morris Disability Questionnaire
The Patient Satisfaction Questionnaire 18 |
The Numerical Pain Rating Scale - Baseline (Day 0)
End of Intervention 1 (after 2 weeks of tele rehabilitation)
End of Intervention 2 (after 2 weeks of conventional Pilates)
The Roland-Morris Disability Questionnaire - Baseline (Day 0)
End of Intervention 1 (after 2 weeks of tele rehabilitation)
End of Intervention 2 (after 2 weeks of conventional Pilates)
The Patient Satisfaction Questionnaire 18 - End of Intervention 1 (after 2 weeks of tele rehabilitation)
End of Intervention 2 (after 2 weeks of conventional Pilates)
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
26/05/2025 |
| 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="0" |
|
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response (Others) -
- By what mechanism will data be made available?
Response (Others) - Not yet decided about the journal where to be published. Will decide it during the end of the research process and update the link further in 6 months of time from the date of commercement of research study.
- For how long will this data be available start date provided 31-05-2026 and end date provided 30-06-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
The present study aims to compare the effectiveness of tele rehabilitation versus the conventional mode of mat Pilates in individuals with acute non specific low back pain. This is a non randomized crossover study involving participants aged between 20 to 40 years who experience acute non specific low back pain of less than six weeks duration. Participants will first undergo two weeks of tele rehabilitation based mat Pilates followed by a crossover into two weeks of conventional in person mat Pilates, completing both interventions over a total duration of four weeks. There will be no washout period due to the short duration and acute nature of the condition. The tele rehabilitation sessions will be delivered through online platforms under the supervision of a qualified physiotherapist while the conventional mode will be delivered face to face in a clinical setting. Each phase will consist of three sessions per week each lasting approximately 35 minutes. The primary outcomes measured will be pain intensity using the Numerical Pain Rating Scale, disability level using the Roland Morris Disability Questionnaire and patient satisfaction assessed using the Patient Satisfaction Questionnaire 18. Assessments will be conducted at baseline and after completion of both intervention phases. This study aims to assess the clinical effectiveness and feasibility of tele rehabilitation as an alternative to conventional physiotherapy for managing acute non specific low back pain. |