| CTRI Number |
CTRI/2024/07/071555 [Registered on: 30/07/2024] Trial Registered Prospectively |
| Last Modified On: |
24/07/2024 |
| 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 Rhythmic Stabilization Exercises on Pain, Posture, and Flexibility in Patients with Chronic Upper Back Pain |
|
Scientific Title of Study
|
Impact of rhythmic stabilization exercises on pain, posture and flexibility in chronic upper 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 |
Gajanan Pawar |
| Designation |
PG student |
| Affiliation |
DR. D.Y. PATIL COLLEGE OF PHYSIOTHERAPY PIMPRI PUNE |
| Address |
Musculoskeletal Department, 3rd floor, Dr. D.Y. Patil College of Physiotherapy, Pimpri
Pune
MAHARASHTRA
411018
Pune
MAHARASHTRA
411018
India |
| Phone |
8857967179 |
| Fax |
|
| Email |
gajanan516pawar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Seema Saini |
| Designation |
PROFESSOR |
| Affiliation |
Dr. D. Y. Patil college of physiotherapy pimpri pune |
| Address |
Musculoskeletal department, 3rd floor, Dr. D. Y. Patil college of Physiotherapy, Pimpri
Pune
MAHARASHTRA
411018
Pune
MAHARASHTRA
411018
India |
| Phone |
8087564345 |
| Fax |
|
| Email |
seema.saini@dpu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Seema Saini |
| Designation |
PROFESSOR |
| Affiliation |
Dr. D. Y. Patil college of physiotherapy pimpri pune |
| Address |
Musculoskeletal department, 3rd floor, Dr. D. Y. Patil college of Physiotherapy, Pimpri
Pune
MAHARASHTRA
411018
Pune
MAHARASHTRA
411018
India |
| Phone |
8087564345 |
| Fax |
|
| Email |
seema.saini@dpu.edu.in |
|
|
Source of Monetary or Material Support
|
| Dr. D. Y. Patil college of Physiotherapy
Pimpri
Pune
411018
Maharashtra |
|
|
Primary Sponsor
|
| Name |
Gajanan Pawar |
| Address |
Musculoskeletal Department, 3rd floor, Dr. D.Y. Patil College of Physiotherapy, Pimpri
Pune
MAHARASHTRA
411018 |
| Type of Sponsor |
Other [Self] |
|
|
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 Gajanan Pawar |
Dr. D.Y Patil, Pune |
Room number-1,Department
of Musculoskeletal
Physiotherapy, 3rd floor
DR. D.Y Patil College of
Physiotherapy, Sant
Tukaram Nagar, Pimpri,
Pune, Maharashtra
411018
Pune
MAHARASHTRA
Pune
MAHARASHTRA |
8857967179
gajanan516pawar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee of Dr. D. Y. Patil college of Phyiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
rhythmic stabilization eercie |
participant performed 3 Set of 15 repetition for 4 week |
| Comparator Agent |
Routine eerciSe |
participant performed 3 Set of 15 repetition for 4 week
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Back pain including upper back pain.
Pain intensity 1to 6 on visual analogue scale |
|
| ExclusionCriteria |
| Details |
Subjects who are Obese
Pregnant Women
Any other Musculoskeletal disorders with pain and radiation to the upper limbs
Acute inflammatory disorders of cervical spine
Any underlying pathology or surgery in and around the upper body leading to pain
History of severe back injury such as fracture or disk herniation
Any shoulder Related Injury |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
flexible ruler to assess upper back lordosis
To assess head neck posture and craniovertebral angle.
Visual analog scale |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| N/A |
N/A
|
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
05/08/2024 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Rhythemic stabilization has been found effective on pain, flexibility and functional ability in chronic low back pain so now we are looking for posture and flexibility in upper back pain. Quality of Life of upper back pain negatively impacts an individual’s quality of life, affecting their ability to perform daily tasks and participate in physical activities. Effective interventions can improve the overall well-being of those suffering from upper back pain. |