| CTRI Number |
CTRI/2020/10/028592 [Registered on: 23/10/2020] Trial Registered Prospectively |
| Last Modified On: |
01/03/2021 |
| 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
|
Comparison of different taping techniques in desk job workers having low back pain |
|
Scientific Title of Study
|
Effectiveness of different kinesio taping techniques in desk job workers having low back pain without Radiculopathy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Amita Aggarwal |
| Designation |
Assistant Professor |
| Affiliation |
Dr.D.Y. Patil College of Physiotherapy |
| Address |
Department of kinesiology
1st cabin,3rd floor, Dr.
D.Y.Patil College of
Physiotherapy,Sant Tukaram
Nagar,Pimpri,Pune.
Pune
MAHARASHTRA
411018
India |
| Phone |
7986972513 |
| Fax |
|
| Email |
amita15pgi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Amita Aggarwal |
| Designation |
Assistant Professor |
| Affiliation |
Dr.D.Y. Patil College of Physiotherapy |
| Address |
Department of kinesiology
1st cabin,3rd floor, Dr.
D.Y.Patil College of
Physiotherapy,Sant Tukaram
Nagar,Pimpri,Pune.
MAHARASHTRA
411018
India |
| Phone |
7986972513 |
| Fax |
|
| Email |
amita15pgi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mokshi koul |
| Designation |
PG Student |
| Affiliation |
Dr.D.Y. Patil College of Physiotherapy |
| Address |
PG-2 Classroom,3rd floor,Dr.
D.Y. Patil College of Physiotherapy,Sant Tukaram
Nagar,Pimpri,Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
7709467583 |
| Fax |
|
| Email |
mokshik23@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr.D.Y Patil College of Physiotherapy,Pimpri,Pune |
|
|
Primary Sponsor
|
| Name |
Amita Aggarwal |
| Address |
Department of Kinesiotherapy 1st cabin 3rd floor ,Dr.D.Y. Patil College of Physiotherapy, Sant Tukaram Nagar, 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 |
| Amita Aggarwal |
Dr.D.Y. Patil College of Physiotherapy,Pimpri,Pune |
Department of Kinesiology 1st CABIN,3rd floor,D.Y.Patil College of Physiotherapy,Sant Tukaram Nagar,Plot no BGP/190,Pimpri-Chinchwad, Maharashtra 411018
Pune
MAHARASHTRA |
7986972513
amita15pgi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr.D.Y.Patil Vidyapeeth,Pune |
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 |
kinesio taping fascia correction technique with conventional exercise |
Treatment will include six sessions of taping for two weeks (three days per week on alternate days) |
| Comparator Agent |
Muscle (Y)Kinesiology taping technique with conventional exercise |
Treatment will include six sessions of taping for two weeks(three days per week on alternate days) |
| Intervention |
Muscle(I) kinesiology taping technique with conventional exercise |
Treatment will include six sessions of taping for two weeks(three days per week on alternate days) |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Individuals within age group of 30-50 years
2.Desk job workers having low back pain without radiculopathy
3.Working for 6-8 hrs with experience of more than four years
4.Ptients presenting with low back disability score(ODI) in between 21%-60% |
|
| ExclusionCriteria |
| Details |
1.Disc prolapse with sciatica
2. Any recent fractures
3 Sacroiliacjoint dysfunction
4.Radiating pain
5.Scoliotic deformities
6.Spondylolisthesis
7.Neurological impairment of upper limb and lower limb.
8.Cardiovascular problems
9.Person having psychological issues
10.Infection
11.Diabetes
12.Spinal cord compression
13.hip joint pain |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Composite pain index
2.Oswestry Disability index
3.Lumbar range of motion |
on the first and last day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Back performance scale |
on the first and last day |
|
|
Target Sample Size
|
Total Sample Size="33"
Sample Size from India="33"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/10/2020 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Here is the research evidence that includes effectiveness of different kinesio taping techniques in desk job workers having low back pain without radiculopathy.
Objectives: 1. To determine the effect of Muscle (I) taping technique in desk job workers having low back pain without radiculopathy 2. To determine the effect of Muscle(Y) taping technique in desk job workers having low back pain without radiculopathy. 3. To determine the effect of Kinesio taping fascia correction technique in desk job workers having low back pain without radiculopathy. 4. To compare the effect of Muscle (I) taping technique, Muscle (Y) taping technique, Kinesio taping fascia correction technique in desk job workers having low back pain without radiculopathy Methodology: Based on the inclusion and exclusion criteria subjects will be divided into 3 groups. Group A will be given Muscle(I) taping technique with conventional exercise Group B will be given Muscle (Y) taping technique with conventional exercise Group C will be given kinesiotaping fascia correction technique with conventional exercise Though conventional exercise will be given regularly, k tape will be changed thrice a week after every 2 days. six sessions of k tape will be given for 2 weeks..
|