| CTRI Number |
CTRI/2018/06/014399 [Registered on: 04/06/2018] Trial Registered Prospectively |
| Last Modified On: |
01/06/2018 |
| 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
|
A Comparison Of Effect Of Mirror Therapy Versus Shoulder Exercises In Chronic Shoulder Pain |
|
Scientific Title of Study
|
To Compare The Effect Of Mirror Therapy And Shoulder Exercises In Patients With Chronic Shoulder Pain- A Randomized Controlled Trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nikita Irkal |
| Designation |
Post Graduate Student |
| Affiliation |
sdm medical college and hospital |
| Address |
SDM College Of Medical Sciences Sattur Dharwad
Physiotherapy OPD NO. 5
SDM College Of Medical Sciences and Hospital Manjushri Nagar Sattur Dharwad
Physiotherapy OPD NO.5
Dharwad
KARNATAKA
580009
India |
| Phone |
9980553178 |
| Fax |
919980553178 |
| Email |
nikita.irkal@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prashant Mukkanavar |
| Designation |
Professor |
| Affiliation |
SDM Medical College and Hospital |
| Address |
SDM College of Medical Sciences Sattur Dharwad
Physiotherapy Department
OPD No.5
SDM College of Medical Sciences and Hospital Manjushri Nagar Sattur Dharwad
Physiotherapy department
OPD No. 5
Dharwad
KARNATAKA
580009
India |
| Phone |
9036981180 |
| Fax |
08362462253 |
| Email |
drprashantmb@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nikita Irkal |
| Designation |
Post Graduate Student |
| Affiliation |
SDM Medical College and Hospital |
| Address |
SDM College of Medical Sciences Sattur Dharwad
SDM College of Medical Sciences and Hospital Manjushri Nagar Sattur Dharwad
Physiotherapy Department
OPD No.5
Dharwad
KARNATAKA
580009
India |
| Phone |
9980553178 |
| Fax |
919980553178 |
| Email |
nikita.irkal@rediffmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
SDM College of Medical Science and Hospital |
| Address |
SDM Medical College Manjushri Nagar Sattur Dharwad |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Nikita Irkal |
SDM College of Medical Sciences and Hospital |
OPD No 5
Physiotherapy OPD
Manjushree Nagar
SATTUR
DHARWAD
Dharwad
KARNATAKA |
9980553178
08362462253
nikita.irkal@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SDM Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
CHRONIC SHOULDER PAIN, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control Group |
Mirror Therapy along with Exercises will be given. |
| Intervention |
Experimental Group |
Mirror Therapy |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Pain more than 3 months.
Age 40-60 years.
Unilateral shoulder pain.
Patients willing to sign the consent form
|
|
| ExclusionCriteria |
| Details |
Neurological conditions and multiple system disorder.
Recent surgeries of shoulder less than 3 months.
Inability to provide informed consent and/or complete the written questionnaire.
Patients having hearing, speech and vision impairment.
Subjects not willing to participate.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
VAS
SPADI |
Pre and Post Interevntion |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Pain Catastrophizing Scale
Tampa Scale of Kinesiophobia |
Pre and Post Intervention |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 |
|
Date of First Enrollment (India)
|
10/06/2018 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none as of now |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
One of the treatment strategy used by physical therapists to treat the hypervigilence of CNS is Graded Motor Imagery. GMI components consists of laterality training, motor imagery, mirror therapy which is seen to decrease the central sensitization by reducing pain and sensitivity. In addition GMI has been shown in improving the movement and reducing the disability. There are many studies carried out in the form of exercises and have proved to be beneficial for the treatment of chronic shoulder pain. Recently GMI component that is mirror therapy is also beneficial in treating the chronic painful conditions. However, there are lack of studies comparing the effectiveness of exercise therapy and mirror therapy in chronic shoulder pain. Hence the strong need arises to compare mirror therapy and shoulder exercises in patients with chronic shoulder pain using the standardized outcome measures. |