| CTRI Number |
CTRI/2022/04/041921 [Registered on: 19/04/2022] Trial Registered Prospectively |
| Last Modified On: |
12/04/2022 |
| 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 patients |
|
Scientific Title of Study
|
An Online Mindfulness based Intervention impacts Chronic Non-specific Low Back pain: A prospective Randomized Controlled trial in Indian patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anirban Pal |
| Designation |
Consultant |
| Affiliation |
Apollo Medical center |
| Address |
Apollo Medical Center,
Department of Anaesthesia and pain medicine, 48/1F Leela Roy Sarani, Kolkata
Kolkata
WEST BENGAL
700019
India |
| Phone |
|
| Fax |
|
| Email |
pal.anirban1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anirban Pal |
| Designation |
Consultant |
| Affiliation |
Apollo Medical center |
| Address |
Apollo Medical Center,
Department of Anaesthesia and pain medicine, 48/1F Leela Roy Sarani, Kolkata
Kolkata
WEST BENGAL
700019
India |
| Phone |
|
| Fax |
|
| Email |
pal.anirban1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anirban Pal |
| Designation |
Consultant |
| Affiliation |
Apollo Medical center |
| Address |
Apollo Medical Center,
Department of Anaesthesia and pain medicine, 48/1F Leela Roy Sarani, Kolkata
Kolkata
WEST BENGAL
700019
India |
| Phone |
|
| Fax |
|
| Email |
pal.anirban1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kalyani ESI Hospital, A Block, Kalyani, Nadia, Pin 741235 |
|
|
Primary Sponsor
|
| Name |
Anirban Pal |
| Address |
43/6/5 Jheel road
Kolkata 700031 |
| 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 |
| Anirban Pal |
Kalyani ESI Hospital |
Department of public health,
A Block, Kalyani, Pin 741235
Nadia
WEST BENGAL |
09830761649
pal.anirban1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kalyani ESI hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M95-M95||Other disorders of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Mindfulness based intervention |
5 online sessions, one session each week, total duration 5 weeks |
| Comparator Agent |
Self care control sessions |
5 online Placebo sessions, one session each week, total duration 5 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Having chronic low back pain for at least 3 months |
|
| ExclusionCriteria |
| Details |
Severe comorbid conditions |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| pain intensity by numerical rating scale |
At interval of 5 weeks, before and after the program |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| chronic pain acceptance by Chronic pain acceptance score |
At 5 weeks time interval: before and after the program |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
20/04/2022 |
| 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="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
60 chronic low back pain patients were randomized to cases and controls. Case group will receive online Mindfulness-based intervention 5 sessions while the control group attends self-care sessions. After 5 weeks the effects on pain intensity and chronic pain acceptance studied. |