| CTRI Number |
CTRI/2025/04/085055 [Registered on: 17/04/2025] Trial Registered Prospectively |
| Last Modified On: |
28/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Find out effectiveness of Yoga Asanas on lower back pain in bikers. |
|
Scientific Title of Study
|
Effect of selected Yoga Asanas in the management of lower back pain among bikers |
| 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 Rakshanda Dashottar |
| Designation |
Post Graduate Scholar |
| Affiliation |
Parul Institute of Ayurved and Research, Vadodara,Gujarat |
| Address |
Department of Swasthavritta and Yoga,
Parul Institute of Ayurved And Research,
Parul University
Vadodara,Gujarat,India
Pin: 391760
Vadodara
GUJARAT
391760
India |
| Phone |
9981258907 |
| Fax |
|
| Email |
rakshandadashottar8@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dhaivat Vora |
| Designation |
Professor and HOD |
| Affiliation |
Parul Institute of Ayurved and Research, Vadodara,Gujarat |
| Address |
Department of Swasthavritta and Yoga,
Parul Institute of Ayurved And Research,
Parul University
Vadodara,Gujarat,India
Pin: 391760
Vadodara
GUJARAT
391760
India |
| Phone |
9879287123 |
| Fax |
|
| Email |
dhaivat.vora17591@paruluniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dhaivat Vora |
| Designation |
Professor and HOD |
| Affiliation |
Parul Institute of Ayurved and Research, Vadodara,Gujarat |
| Address |
Department of Swasthavritta and Yoga,
Parul Institute of Ayurved And Research,
Parul University
Vadodara,Gujarat,India
Pin: 391760
Vadodara
GUJARAT
391760
India |
| Phone |
9879287123 |
| Fax |
|
| Email |
dhaivat.vora17591@paruluniversity.ac.in |
|
|
Source of Monetary or Material Support
|
| Dr Rakshanda Dashottar, Post Graduate Scholar, Department of Swasthavritta and Yoga,
Parul Institute of Ayurved And Research,
Parul University
Vadodara,Gujarat,India
Pin: 391760 |
|
|
Primary Sponsor
|
| Name |
Dr Rakshanda Dashottar |
| Address |
Post Graduate Scholar, Department of Swasthavritta and Yoga, Parul Institute of Ayurved And Research, Parul University Vadodara,Gujarat,India Pin: 391760 |
| 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 Rakshanda Dashottar |
Khemdas Hospital |
Department of Panchakarma OPD No. 7, Department of Kayachikitsa OPD No. 8 and Department of Swasthavritta and Yoga OPD No. 10, Ground Floor, Khemdas Hospital, Ishwarpur, P.O Limda, Waghodia,Vadodara,Gujarat,India 391760
Vadodara
GUJARAT |
9981258907
rakshandadashottar8@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMITTE IEC-PIARHR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M545||Low back pain. Ayurveda Condition: SULAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | NIL | (Procedure Reference: NIL, Procedure details: NIL)
| | 2 | Intervention Arm | Lifestyle | - | - | Dinacarya: , Ritucarya: , Acara Rasayana:, Other:Yoga Asanas, Pathya/Apathya:no, Pathya:, Apathya: |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
a) Individuals who travel a minimum of 45 minutes per day by bike.
b) Individuals who carry a weight of 1.5 - 2.5 kg.
c) Individuals experiencing strain pain in the lower back.
d) Both male and female participants, Age group: 18-40 years.
e) Willingness to participate in a yoga intervention program.
f) Ability to understand and follow the instructions for yoga practice
g) People riding both automatic and manual bikes.
|
|
| ExclusionCriteria |
| Details |
a) Presence of serious spinal pathologies or injuries.
b) Severe psychiatric or psychological disorders that may interfere with participation or assessment.
c) History of recent musculoskeletal surgery or acute trauma to the lower back.
d) Chronic medical conditions that may limit participation or increase risk during yoga practice.
e) Inability to commit to the study schedule due to conflicting work or personal obligations.
f) Individuals with a history of herniation or disc prolapse.
g) Individuals suffering from autoimmune diseases of the spine such as ankylosing spondylitis.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Evaluate effect of selected yoga asanas in the management of lower back pain among bikers. |
a) Duration of the Treatment:21 days
b) Follow-Up: [yoga session will be conducted till 21th day and then.
c) Weekly follow up will be taken till 21 days of Treatment.
d) Break for 7 days of Yoga Asanas.
c)Follow-up will be taken on the 28th day to assess the recurrence of lower back pain
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Evaluate the improvement in functional ability and quality of life of bikers with lower back pain after practicing specific yoga asanas. |
1 Year 6 Month |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
30/04/2025 |
| 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="1"
Months="6"
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 - NO
|
|
Brief Summary
|
· This research is necessary
since lower back discomfort is a common problem among bikers due to the lengthy
and repetitive postures needed for riding. Despite being common, there aren’t
many specialized therapies available to treat lower back pain in this
demographic.
· It is imperative to
investigate the effectiveness of yoga through specific asanas catered to the
demands of bikers, given its potential benefits in enhancing flexibility,
strength, and posture.
· To close this gap, this
study will offer evidence-based suggestions for lower back pain management
techniques that are specific to bikers, thereby improving their general health
and performance. |