| CTRI Number |
CTRI/2017/06/008777 [Registered on: 07/06/2017] Trial Registered Prospectively |
| Last Modified On: |
07/06/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Soft tissue injury and its healing |
|
Scientific Title of Study
|
Prevalence of Work Related Musculoskeletal Disorders among Beedi workers of Dakshina Kannada and Therapeutic ultrasound evaluation of soft tissue injury. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shemjaz Arakkal M |
| Designation |
Assistant Professor |
| Affiliation |
Yenepoya University |
| Address |
Yenepoya Physiotherapy College,
Yenepoya University,
Derelakatte
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
7204896962 |
| Fax |
|
| Email |
shemjaz@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shemjaz Arakkal M |
| Designation |
Assistant Professor |
| Affiliation |
Yenepoya University |
| Address |
Yenepoya Physiotherapy College,
Yenepoya University,
Derelakatte
KARNATAKA
575018
India |
| Phone |
7204896962 |
| Fax |
|
| Email |
shemjaz@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shemjaz Arakkal M |
| Designation |
Assistant Professor |
| Affiliation |
Yenepoya University |
| Address |
Yenepoya Physiotherapy College,
Yenepoya University,
Derelakatte
KARNATAKA
575018
India |
| Phone |
7204896962 |
| Fax |
|
| Email |
shemjaz@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Yenepoya University,
Deralakatte,
Mangalore 575018
Karnataka, India. |
|
|
Primary Sponsor
|
| Name |
Yenepoya University |
| Address |
Derelakatte
Mangalore 575018
Karnataka
India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Shemjaz Arakkal M |
Yenepoya University |
Deralakatte,
Mangalore 575018
Karnataka
India
Dakshina Kannada
KARNATAKA |
7204896962
shemjaz@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Yenepoya University Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
work related Muskuloskeletal Injuries and Bicipital tendinitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
| Intervention |
Therapeutic Ultrasound therapy |
Subjects diagnosed with bicipital tendinitis will be treated using 1MHz therapeutic ultrasound.
Dosage is as follows.
Pulse ratio: Acute – 1:4/3, Sub acute – 1:2/1, Chronic – 1:1/Continuous.
Intensity: Acute – 0.1 -0.3 W/cm2, Sub acute – 0.2 – 0.5 W/cm2, Chronic – 0.3 – 0.8 W/cm2
Treatment time: 1 x (no. of times treatment head fits onto tissue to treat) x (pulse factor).
Treatment sessions: 16 sessions in a period of 4 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
i. Subjects with pain in an around anterior part of the shoulder.
ii. Clinical finding of point tenderness on bicipital groove.
|
|
| ExclusionCriteria |
| Details |
i. Patients having any neurodegenerative disorders.
ii. Patients on NSAIDs
iii. Under the influence of alcohol during the time of examination
iv. History of mental illness, cardiac disease, circulatory deficit, recent fracture, IVDP, Sensitive skin, Thyroid disorder.
v. Metal implant at the examination site
vi. Skin allergy.
vii. Patients unable/not willing to provide consent
viii. Open wound or infected wound
Injury to head and neck present at the time of examination. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Numeric Pain Rating Scale
Disability of the Arm, Shoulder, and Hand (DASH) |
2017-2018 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Diagnostic Ultrasound |
2019 |
|
|
Target Sample Size
|
Total Sample Size="515"
Sample Size from India="515"
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)
|
15/06/2017 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
It is always important know what are the common work related
musculoskeletal injuries among beedi workers so that measures can be taken at
the earliest to prevent it from further occurrence. And if therapeutic
Ultrasound can locate and identify the soft tissue injuries, then the treatment
directed by the Physical Therapist can be on the exact effected site. This in
turn may help in better healing and thereby it may reduce the healing time and promote faster recovery.
|