| CTRI Number |
CTRI/2023/08/056037 [Registered on: 02/08/2023] Trial Registered Prospectively |
| Last Modified On: |
25/07/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Mindfulness for chronic low back pain to decrease pain, improve disability and quality of life |
|
Scientific Title of Study
|
Effects of a Mindfulness Based Intervention on Pain Intensity, Disability and Quality of Life of chronic low back pain patients: a Prospective Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anirban Pal |
| Designation |
Assistant Professor |
| Affiliation |
KPC Medical College |
| Address |
Room no 302
Department of Anaesthesia
Kpc medical college
Jadavpur
Kolkata
WEST BENGAL
700032
India |
| Phone |
|
| Fax |
|
| Email |
pal.anirban1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Subrata Roy |
| Designation |
Professor |
| Affiliation |
kpc medical college |
| Address |
Room no 302
Department of Anaesthesia
Kpc medical college
Kolkata
WEST BENGAL
700032
India |
| Phone |
9830761649 |
| Fax |
|
| Email |
raysubrata62@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Subrata Roy |
| Designation |
Professor |
| Affiliation |
kpc medical college |
| Address |
Room no 302
Department of Anaesthesia
Kpc medical college
WEST BENGAL
700032
India |
| Phone |
9830761649 |
| Fax |
|
| Email |
raysubrata62@gmail.com |
|
|
Source of Monetary or Material Support
|
| KPC Medical college
20 raja Subodh Mallick Road
Kolkata 700032 |
|
|
Primary Sponsor
|
| Name |
KPC Medical College |
| Address |
20 Raja Subodh Mallick Road
Jadavpur
Kolkata 700032
|
| 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 |
| Anirban pal |
KPC Medical College |
Room 302
Department of Anaesthesia
20 Raja Subodh Mallick Road
Jadavpur
Kolkata 700032
Kolkata
WEST BENGAL |
9830761649
pal.anirban1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KPC Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M999||Biomechanical lesion, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Mindfulness based intervention |
8 sessions, one session each week of one hour duration. Duration of intervention 2 months. |
| Comparator Agent |
Usual care sessions |
8 usual care sessions, one session each week, total duration of 2 months |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Chronic low back pain for 3 months |
|
| ExclusionCriteria |
| Details |
Cancer, infection, metastasis |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain intensity by Numerical rating scale |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Disability & Quality of life |
2 months |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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 2 |
|
Date of First Enrollment (India)
|
07/08/2023 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
200 patients of chronic low back pain will be subjected to a ’Mindfulness-based intervention’ or ’usual care’ sessions. There will be eight sessions, one session each week. The pre-session and post-session data will be collected. Outcome parameters are pain intensity, disability and quality of life. The data collected will be subjected to statistical analysis. |