| CTRI Number |
CTRI/2018/07/014800 [Registered on: 10/07/2018] Trial Registered Prospectively |
| Last Modified On: |
09/07/2018 |
| 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
|
To study the individual and combined effect of pain education and exercises in patients having low back pain more than 3 months. |
|
Scientific Title of Study
|
TO STUDY THE COMBINED EFFECT OF PAIN NEUROSCIENCE EDUCATION WITH EXERCISES IN COMPARISON WITH PAIN NEUROSCIENCE EDUCATION AND EXERCISES ALONE IN PATIENTS WITH CHRONIC LOW BACK 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 |
Kadam Apurva Sanjay |
| Designation |
Post graduate student. |
| Affiliation |
SDM College of Medical sciences and hospital |
| Address |
SDM College of Medical sciences and hospital,
Interns Hospital,
Manjushree Nagar,
Sattur, Dharwad.
SDM College of Medical sciences and hospital,
Interns Hospital,
Manjushree Nagar,
Sattur, Dharwad.
Dharwad
KARNATAKA
580009
India |
| Phone |
9769214161 |
| Fax |
08362462253 |
| Email |
apu2605@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sweta Kulkarni |
| Designation |
Associate Proffessor |
| Affiliation |
SDM College of Physiotherapy |
| Address |
SDM college of Medical Sciences,
Manjushree Nagar,
Sattur,
Dharwad
SDM college of Medical Sciences,
Manjushree Nagar,
Sattur,
Dharwad
Dharwad
KARNATAKA
580009
India |
| Phone |
9886276543 |
| Fax |
|
| Email |
dr.shweta07@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sweta Kulkarni |
| Designation |
Associate Proffessor |
| Affiliation |
SDM College of Physiotherapy |
| Address |
SDM college of Medical Sciences,
Manjushree Nagar,
Sattur,
Dharwad
SDM college of Medical Sciences,
Manjushree Nagar,
Sattur,
Dharwad
Dharwad
KARNATAKA
580009
India |
| Phone |
9886276543 |
| Fax |
|
| Email |
dr.shweta07@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kadam Apurva Sanjay
SDM college of medicle sciences and hospital
manjushree nagar
sattur
dharwad |
|
|
Primary Sponsor
|
| Name |
Apurva Sanjay Kadam |
| Address |
SDM College of Medical sciences and hospital,
Interns Hospital,
Manjushree Nagar,
Sattur, Dharwad.
580009. |
| 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 |
| Kadam Apurva Sanjay |
SDM college of medical sciences, |
orthopedic physiotherapy opd, block no 5
Manjushree Nagar,
Sattur,
Dharwad
Dharwad
KARNATAKA |
9769214161
08362462253
apu2605@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Permission |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
assessment of pain, quality of life, disability, fear related to pain in patients with chronic low back pain, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
GROUP A |
Group A will receive pain neuroscience education. |
| Intervention |
GROUP B |
Group B will receive pain neuroscience education with exercises. |
| Comparator Agent |
GROUP C |
group c will receive exercises only. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients having low back pain of more than 12 weeks.
2. Patients aged 18-80 years.
|
|
| ExclusionCriteria |
| Details |
1.Low back pain less than 3 months (12 weeks).
2.Suspected spinal pathology like -malignancies, Unhealed vertebral fractures, ankylosing spondylitis, Inflammatory arthritis, radicular syndrome Cauda equina syndrome.
3.Pregnancy.
4.Patients with vision, speech and auditory disorders.
5.Uncontrolled mental health abnormalities like- Bipolar disorder, schizophrenia, major depressive disorder.
6.Unwilling to participate voluntarily.
7.Involvement of other systems/multiple systems issues.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.visual analogue scale.
|
3 weeks, 2 sessions per week.
outcome measures will be assessed at baseline and after 3 weeks.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Oswestry disability index.
2. SF-36 Quality of life questionnaire.
3..Fear Avoidance Beliefs Questionnaire.
|
3 weeks, 2 sessions per week.
outcome measures will be assessed at baseline and after 3 weeks.
|
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
16/07/2018 |
| 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
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Numerous studies have been done to
find out the effectiveness of pain neuroscience education in patients with
chronic low back pain combined with other treatment techniques. But there is lack of evidence showing use of pain neuroscience education with
exercise protocol (stretching and strengthening) in patients with chronic low
back pain. Also the effectiveness of these protocols combined with pain
neuroscience education cannot be judged because of the absence of a control
group. Most of the studies are done in
the western countries and other parts of the world, but studies are lacking in
India. Thus, a very strong need arises to find out the combined effect of pain
neuroscience education with exercises in comparison to pain neuroscience
education and exercises alone on pain intensity, disability, quality of life
and fear associated in patients with chronic low back pain.
|