| CTRI Number |
CTRI/2019/05/019301 [Registered on: 23/05/2019] Trial Registered Prospectively |
| Last Modified On: |
23/01/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Pain neuroscience education and graded motor imagery in patients with chronic shoulder pain |
|
Scientific Title of Study
|
Effect of pain neuroscience education and graded motor imagery on pain, function and quality of life in patients with chronic shoulder pain – An experimental study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vrushali Panhale |
| Designation |
Professor |
| Affiliation |
MGM College of Physiotherapy |
| Address |
Room No: 55, Department of Physiotherapy, MGM Hospital, Sector 1, Kamothe, Navi Mumbai, Maharashtra, India.
Mumbai
MAHARASHTRA
410209
India |
| Phone |
|
| Fax |
|
| Email |
vrushali.d@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prachita Walankar |
| Designation |
Assistant Professor |
| Affiliation |
MGM College of Physiotherapy |
| Address |
Room No: 55, Department of Physiotherapy, MGM Hospital, Sector 1, Kamothe, Navi Mumbai, Maharashtra, India.
Mumbai
MAHARASHTRA
410209
India |
| Phone |
|
| Fax |
|
| Email |
prachita30@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Manali Yadav |
| Designation |
Post graduate student |
| Affiliation |
MGM College of Physiotherapy |
| Address |
Room No: 55, Department of Physiotherapy, MGM Hospital, Sector 1, Kamothe, Navi Mumbai, Maharashtra, India.
Mumbai
MAHARASHTRA
410209
India |
| Phone |
|
| Fax |
|
| Email |
manalieyadav79@gmail.com |
|
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Source of Monetary or Material Support
|
| MGM College of Physiotherapy
Room No: 55, Department of Physiotherapy, MGM Hospital, Sector 1, Kamothe, Navi Mumbai- 410209 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 |
| Vrushali Panhale |
MGM College of Physiotherapy |
Room No: 55, Department of Physiotherapy, MGM Hospital, Sector 1, Kamothe, Navi Mumbai, Maharashtra, India.
Mumbai
MAHARASHTRA |
9867679843
vrushali.d@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Review Committee, MGM College of Physiotherapy, Navi Mumbai |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M759||Shoulder lesion, unspecified, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional therapy |
Shoulder Exercises
Education |
| Intervention |
Graded Motor Imagery |
Implicit Motor Imagery
Explicit motor imagery
Mirror Therapy |
| Intervention |
Pain neuroscience education |
Pain neuroscience education |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients diagnosed with shoulder pain with duration of more than 3 months.
2. Men / women aged between 18 to 65 years.
3. Unilateral shoulder pain.
4. Patient who agreed to sign the consent form. |
|
| ExclusionCriteria |
| Details |
1. Patients unwilling to sign the consent form
2. Shoulder pain considered to be originating from another region like cervical, thoracic spine.
3. Neurological conditions and multiple system disorder.
4. Mental/psychological health issues.
5. patients with any speech, vision or hearing issues
|
|
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Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Numerical Rating Scale
Shoulder Pain and Disability Index (SPADI)
|
Pre intervention and Post Intervention after 4 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Pain Catastrophizing Scale (PCS)
2.Tampa Scale of Kinesiophobia
3. Pain self-Efficacy Questionnaire
4. Hospital Anxiety and Depression Scale
5.SF-36
|
Pre intervention and Post Intervention after 4 weeks
|
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
Final Enrollment numbers achieved (Total)= "36"
Final Enrollment numbers achieved (India)="36" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
06/06/2019 |
| Date of Study Completion (India) |
05/12/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="5"
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)?
|
Brief Summary
Modification(s)
|
Shoulder pain is the third most common cause of
musculoskeletal consultation in primary care, with prevalence rates varying
from 6.9% to 26% for point prevalence and up to 66.7% for lifetime prevalence
in the general population Despite medical and physiotherapy treatment, a large
patient group reports persisting shoulder pain. The treatment of patients with
chronic pain can be complex and challenging. This chronic pain is associated
with increased medical costs, decrease income and huge economic burden and it
also has a negative impact on the patient’s quality of life. The purpose of
this study is to find the effect of Pain Neuroscience Education (PNE) and
Graded Motor Imagery (GMI) on pain, function and quality of life in patients
with chronic shoulder.
Results
showed significant improvement in pre and post intervention in within
group (intra-group) analysis of PNE
group and GMI group for all the variables. But it did not show any significant
results in pre and post intervention of conventional group for pain intensity
at rest, kinesiophobia and physical and mental component summary of quality of
life.
For
between group (inter-group) analysis,a significant difference was seen between
all the three groups when compared with each other. Hence, to find out which
group is more significant post hoc analysis was done where during pairwise
comparison, it was found that conventional group and GMI group showed
significant results in all the variables. Conventional group and PNE group also
showed significant results in all variables except for external rotation
component. Also, when compared between PNE group and GMI group it did not show
any significant results with each other.
Thus,
we concluded that pain neuroscience education (PNE) and graded motor imagery (GMI)
can be an effective intervention which can be used for the treatment of
patients with chronic shoulder pain and provides a strong evidence in reducing
pain, pain catastrophization, kinesiophobia and improves functions thereby
improving quality of life.
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