| CTRI Number |
CTRI/2021/11/038019 [Registered on: 12/11/2021] Trial Registered Prospectively |
| Last Modified On: |
11/11/2021 |
| 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
|
Physiotherapy for trapezitis |
|
Scientific Title of Study
|
Effect of positional release therapy versus passive stretching in upper trapezitis among collegiate smartphone users |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bobbala Harshitha |
| Designation |
post graduate student |
| Affiliation |
SRM institute of science and technology |
| Address |
Room no 8SRM college of physiotherapy SRMIST kattankulathur chengalpattu tamilnadu
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9949195763 |
| Fax |
|
| Email |
bh1607@srmist.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Mrs k Jothi prasanna |
| Designation |
Assistant professor |
| Affiliation |
SRM institute of science and technology |
| Address |
SRM college of physiotherapy SRMIST kattankulathur chengalpattu tamilnadu
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9894475735 |
| Fax |
|
| Email |
jothiprk@srmist.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Bobbala Harshitha |
| Designation |
post graduate student |
| Affiliation |
SRM institute of science and technology |
| Address |
Room no 8 SRM college of physiotherapy SRMIST kattankulathur chengalpattu tamilnadu
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9949195763 |
| Fax |
|
| Email |
bh1607@srmist.edu.in |
|
|
Source of Monetary or Material Support
|
| Srm college of physiotherapy SRMIST |
|
|
Primary Sponsor
|
| Name |
Bobbala Harshitha |
| Address |
SRM college of physiotherapy SRMIST kattankulathur chengalpattu tamilnadu |
| 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 |
| Bobbala Harshitha |
SRMIST |
Rom no 8 srm college of physiotherapy kanchipuram Tamilnadu
Kancheepuram
TAMIL NADU |
9949195763
bh1607@srmist.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M60-M63||Disorders of muscles, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Positional release therapy
Passive stretching |
Group A positional release therapy and cryptherapy duration 6 weeks 2 sessions per week
Group B passive stretching and cryotherapy duration 6 weeks 2 sessions per week |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Tender points in upper trapezitis
Individuals who score more than cutoff the smartphone addiction questionnaire short version
Subjects who can understand and speak English and Hindi along with tamil |
|
| ExclusionCriteria |
| Details |
Healing fractures over neck or upper back region
Wound over upper back region
Deformities like scoliosis tortocollis
Disc pathology neurological disorders and degenerative disorders including cervical spine |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pressure algometer to check the pain level |
6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Neck disability index to find out pain and disability level |
6 weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
15/11/2021 |
| 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="14" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The patients will be selected according to the inclusion and exclusion criteria patients will provide written informed consent for their participation in the study and patient will be explained about the study and protocol the subjects will be selected based on smartphone addiction questionnaire short version and then assessed by using neck disability index questionnaire The participants will be treated with positional release therapy and passive stretching followed by cryotherapy for 2 sessions per week
After 6 weeks again subjects will be assessed that will be measured as post testDoes positional release therapy versus passive stretching have the effect in upper trapezitis among collegiate smartphone users |