CTRI Number |
CTRI/2018/07/014791 [Registered on: 10/07/2018] Trial Registered Prospectively |
Last Modified On: |
17/12/2018 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Physiotherapy (Not Including YOGA) |
Study Design |
Other |
Public Title of Study
|
THE EFFECT OF PAIN EDUCATION AND EXERCISES IN PATIENT SUFFERING WITH SHOULDER PAIN. |
Scientific Title of Study
|
THE EFFECTS OF PAIN NEUROSCIENCE EDUCATION & EXERCISE IN SHOULDER PAIN PATIENTS- 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 |
SURESH MAITY |
Designation |
Post graduate |
Affiliation |
SDM COLLEGE OF PHYSIOTHERAPY |
Address |
SDM college of medical science and hospital
manjushree nagar,
sattur
Dharwad KARNATAKA 580009 India |
Phone |
09091858701 |
Fax |
08362461651 |
Email |
sureshmphysio@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Shweta Kulkarni |
Designation |
Associate professor |
Affiliation |
SDM COLLEGE OF PHYSIOTHERAPY |
Address |
SDM college of medical science and hospital
sattur
Dharwad KARNATAKA 580009 India |
Phone |
09091858701 |
Fax |
08362461651 |
Email |
dr.shweta07@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Shweta Kulkarni |
Designation |
Associate professor |
Affiliation |
SDM COLLEGE OF PHYSIOTHERAPY |
Address |
SDM college of medical science and hospital
sattur
Dharwad KARNATAKA 580009 India |
Phone |
09091858701 |
Fax |
08362461651 |
Email |
dr.shweta07@gmail.com |
|
Source of Monetary or Material Support
|
Suresh Maity
SDM college of physiotherapy sattur dharwad |
|
Primary Sponsor
|
Name |
Suresh Maity |
Address |
SDM college of medical science and hospital, manjushree nagar, sattur |
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 |
Suresh Maity |
SDM college of medical science and hospital |
Orthopedic physiotherapy outpatient department no.5 Dharwad KARNATAKA |
9091858701 08362461651 sureshmphysio@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional ethics committee permission |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: M95-M95||Other disorders of the musculoskeletal system and connective tissue, Shoulder pain , |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Group Exercise |
All the exercise will tailor made as per patients complaint |
Intervention |
Group Pain Neuroscience Education |
Pain Education, Tactile Discrimination, Graded Motor Imagery, Laterality Training, Explicit Motor Imagery, Mirror therapy |
Intervention |
Group Pain Neuroscience Education along with Exercise |
Exercises will be tailor made, Pain Education, Tactile Discrimination, Graded Motor Imagery, Laterality Training, Explicit Motor Imagery, Mirror therapy |
|
Inclusion Criteria
|
Age From |
30.00 Year(s) |
Age To |
70.00 Year(s) |
Gender |
Both |
Details |
1. Patients diagnosed as shoulder pain with duration more than 3 months by orthopedician.
2. Men / women aged between 30 to 70 years.
3. Unilateral shoulder pain.
4. Pain after shoulder surgery (more than 3 months).
5. Patient who agreed to sign the consent form. |
|
ExclusionCriteria |
Details |
1. Pain less than 3 months.
2. Shoulder pain considered to be originating from another region like cervical, thoracic spine.
3. Neurological conditions and multiple system disorder.
4. Subject with vision, auditory & speech problems.
5. Mental/psychological health issues.
6. Inability to provide informed consent and/or complete the written questionnaire.
7. Subjects not willing to participate. |
|
Method of Generating Random Sequence
|
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Participant Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Visual analog scale
SPADI |
2 time assessment
|
|
Secondary Outcome
|
Outcome |
TimePoints |
Tampa scale of kinesiophobia
SF-36 16
|
2 time assessment |
|
Target Sample Size
|
Total Sample Size="99" Sample Size from India="99"
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)
|
17/07/2018 |
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 yet |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Shoulder pain is a
very common musculoskeletal disorder. The
lifetime prevalence of shoulder pain in India is as high as 67%.The prevalence & incidence of shoulder pain varies
largely across age & population. It has been reported that it occurs most
commonly in middle age adults, women are prone to develop shoulder pain
according to the literature. However, some prevalence studies did not find any
significant difference in shoulder pain among men and women. The most common source of shoulder
pain is the rotator cuff, accounting for over two-thirds of cases and age,
gender, diabetes & alcoholism are considered as various risk factors for shoulder pain. Common conditions
that can result in chronic shoulder pain include rotator cuff disorders,
adhesive capsulitis, shoulder instability, shoulder arthritis. According to a study, prevalence of rotator cuff impingement is 31%,
also in 15.7% patients no specific diagnosis could be made. The factors that
start an episode of shoulder pain are not necessarily the same as those that
contribute to persistent and chronic pain. Pain is a complex experience that
includes multiple dimensions but a recent definition of pain by Moseley (2003)
defines pain as “a multiple system output that is activated by an individual’s
specific neural signature.†A cognitive based education known as pain neuroscience education is used to treat
both the aspects of pain by helping patients gain an increased understanding of
the biological processes underpinning their pain state and by focusing on
neurophysiology, neurobiology and processing of pain. Studies that have used
pain neuroscience education in the treatment of chronic musculoskeletal pain
& low back pain have been shown to decrease the fear, pain
catastrophization, limitation in the movement. Many treatment
options are available to treat chronic shoulder pain, but these treatment approaches
only focus on the physical aspect of pain rather than psychological aspect, as
well as there are limited studies done to see the effectiveness of Pain
Neuroscience Education on chronic shoulder pain whereas, further studies have
been done to see the effectiveness of mirror therapy in patients with shoulder
pain, which is also a part of pain neuroscience education. |