| CTRI Number |
CTRI/2024/08/072846 [Registered on: 21/08/2024] Trial Registered Prospectively |
| Last Modified On: |
20/08/2024 |
| 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
|
A study to find the effect of I and Y kinesio taping with core stability exercise in patients of chronic non-specific low back pain |
|
Scientific Title of Study
|
Effect of core stability exercise with I and Y kinesio Taping on pain and quality of life among chronic non-specific low back pain patients :A two -group Randomized controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Deepannita Awasthi |
| Designation |
PhD Scholar |
| Affiliation |
School of Health Sciences CSJMU Kanpur |
| Address |
School of Health Sciences, Department of Physiotherapy SHS 106 CSJMU Kanpur
Kanpur Nagar
UTTAR PRADESH
208024
India |
| Phone |
7985867348 |
| Fax |
|
| Email |
dawasthi2496@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Deepannita Awasthi |
| Designation |
PhD Scholar |
| Affiliation |
School of Health Sciences CSJMU Kanpur |
| Address |
School of Health Sciences, Department of Physiotherapy SHS106 CSJMU Kanpur
Kanpur Nagar
UTTAR PRADESH
208024
India |
| Phone |
7985867348 |
| Fax |
|
| Email |
dawasthi2496@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Digvijay Sharma |
| Designation |
Director/Assistant Professor |
| Affiliation |
school of health sciences CSJMU kanpur |
| Address |
School of Health Sciences Department of Physiotherapy SHS106 CSJMU Kanpur
Kanpur Nagar
UTTAR PRADESH
208024
India |
| Phone |
9839217108 |
| Fax |
|
| Email |
digvijaysharma@csjmu.ac.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Deepannita Awasthi |
| Address |
school of health sciences Physiotherapy Department (SHS106) CSJMU Kalyanpur Kanpur 208024 Uttar Pradesh India
Kalyanpur Kanpur Uttar Pradesh India PIN -208024 |
| 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 |
| Deepannita Awasthi |
school of health sciences |
Department of Physiotherapy CSJMU SHS106 (208024)Kalyanpur Kanpur UP
Kanpur Nagar
UTTAR PRADESH |
7985867348
dawasthi2496@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| human ethical committee |
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, (2) ICD-10 Condition: M959||Acquired deformity of musculoskeletal system, unspecified, (3) ICD-10 Condition: M959||Acquired deformity of musculoskeletal system, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
kinesio taping and core stability exercise |
kinesio taping will be given with the I and Y taping method for that allergic test will be done and it will be seen the effectiveness of the Y shape, along with core stability exercise will be given for that couch will be required. Y taping will start in a neutral spine position of the participant, and later the base of the Y strip will be attached to the sacroiliac joint area, a minimum of 5 cm below the initiation of pain. The participant will be asked to perform flexion with rotation to opposite side movement with slight tension 15-25% or paper-off tension for approximately 5 cm, The physiotherapist laid down the tail with no tension. Either the patient was returned to a neutral position or moved into forward flexion with rotation to the opposite side so that the second Y-tail would be properly applied. Core stability exercises will be continued with a 10-second hold and a 5-second relax. The total treatment session will be 45 minutes. The treatment will be continued three times in a week for 4 weeks. |
| Intervention |
kinesiotaping and core stability exercise |
Kinesio taping will be given with the I and Y Taping method for that allergic test to be done and it will be seen the effectiveness of I shape, along with core stability exercises will be given for that couch will be required.
I taping will start in a neutral spine position firstly the posterior superior iliac spine and thoracic vertebrae 12, will be carefully marked on the bodys surface of the participant, and then the participant will flex the spine then two I strips will be applied parallel to the spine with slight 10-15% slight stretch in both the right and left side from the posterior superior iliac spine T-12 vertebrae. Core stability exercises will be continued with a 10-second hold and 5-second relax. The total treatment session will be 45 minutes. The treatment will be continued three times in a week for 4 weeks. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
the age group will be from 30 to 55 years.
both genders male and female.
a minimum pain intensity score of 3 and above on a 10 cm long in NRS
pain arising from degenerative disese
medically diagnosed with chronic non-specific low back pain for more than three months.
|
|
| ExclusionCriteria |
| Details |
pain coming to the buttock radiating to legs on either side
any infection
cancer
spinal pathologies such as cauda equina syndrome, disc herniation, spinal stenosis
pregnant females
psychological issues
allergy from Kinesio taping
severe neurological causes
no history of trauma |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| pain and quality of life |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="142"
Sample Size from India="142"
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)
|
31/08/2024 |
| 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="2"
Months="1"
Days="1" |
|
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 - 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 - Informed Consent Form
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [dawasthi2496@gmail.com].
- For how long will this data be available start date provided 09-08-2024 and end date provided 09-05-2025?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - no
|
|
Brief Summary
|
chronic non-specific low back pain is defined as pain persisting in the lumbar area for three months. It is one of the leading causes of disability which results in functional impairment. The study is a randomized controlled trial using computer-generated randomization and a purposive sampling technique. In this study sample size was calculated by using G-power software aged between 30 and 55 years The total number of patients will be 142. The patients will be recruited from tertiary care hospitals and Physiotherapy OPD of the School of Health Sciences. After obtaining patient consent and baseline screening for allergic reaction to the skin. The outcomes are pain and quality of life for Pain Numeric pain rating scale will be used and for quality of life SF-36 will be used . |