| CTRI Number |
CTRI/2025/06/088726 [Registered on: 12/06/2025] Trial Registered Prospectively |
| Last Modified On: |
16/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Occupational Therapy] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Combined effect of Task Oriented Training and Cognitive Behavior Therapy in improving performance in Low back pain |
|
Scientific Title of Study
|
Effectiveness of task oriented training combined with cognitive behavioral therapy
on occupational Performance among patients with Low Back Pain
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sharmistha Mohanty |
| Designation |
PG Scholar |
| Affiliation |
Chettinad School of Occupational Therapy, CHRI, CARE |
| Address |
A Block, Department of Occupational Therapy , Chettinad School of Occupational Therapy , Chettinad Health City, OMR , Kelambakkam ,Chennai
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
8847846575 |
| Fax |
|
| Email |
Sharmishthalora@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pankaj Kumar |
| Designation |
Professor and Dean |
| Affiliation |
Chettinad School of Occupational Therapy, CHRI, CARE |
| Address |
Dean Office , A Block, Department of Occupational Therapy , Chettinad School of Occupational Therapy , Chettinad Health City, OMR , Kelambakkam ,Chennai
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
9910410156 |
| Fax |
|
| Email |
dean.csot@care.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pankaj Kumar |
| Designation |
Professor and Dean |
| Affiliation |
Chettinad School of Occupational Therapy, CHRI, CARE |
| Address |
Dean Office , A Block, Department of Occupational Therapy , Chettinad School of Occupational Therapy , Chettinad Health City, OMR , Kelambakkam ,Chennai
TAMIL NADU
603103
India |
| Phone |
9910410156 |
| Fax |
|
| Email |
dean.csot@care.edu.in |
|
|
Source of Monetary or Material Support
|
| Chettinad School Of Occupational Therapy, Chettinad Hospital and Research Institute,
Chettinad Health City,
Rajiv Gandhi Salai,
Kelambakkam - 603 103,
Chengalpattu District, Chennai,
Tamil Nadu, India. |
|
|
Primary Sponsor
|
| Name |
Sharmistha Mohanty |
| Address |
Room no-9 , Pink Premium Ladies Hospital, SRS Nagar road, Kelambakkam , 603103 |
| 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 |
| Dr Pankaj Kumar |
Chettinad General Hospital |
Ward No.24, OT-Ortjo Unit, Department of Occupational Therapy, Chettinad General Hospital , Chettinad Health City, OMR , Kelambakkam , Chennai, Tamilnadu
Kancheepuram
TAMIL NADU |
9910410156
dean.csot@care.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee (CARE IHEC-I) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M545||Low back pain, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
COPM |
Pretest at the beginning of study and post test at the end of 4 week intervention session using COPM. |
| Intervention |
Task oriented training with cognitive behavior therapy |
Activities of daily living such as washing cloths, cooking etc based on principle of Task Oriented training will be combined with cognitive behavior therapy using positive reinforcement, assertiveness for period of 4 week. The total number of session provided during the study will be 24. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
- Patients who are diagnosed with Low Back Pain
- Both gender (Male & Female)
- The patients age group between 18-65 years.
- Participants who can regularly follow interventions. |
|
| ExclusionCriteria |
| Details |
- Undiagnosed Low Back Pain patient
- Patients having any other neurological disorder
- Patient having cognitive challenges
- Any other medical conditions severe in nature |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Canadian Occupational Performance Measure (COPM) |
At baseline and at 4 week of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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
Modification(s)
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
07/07/2025 |
| 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
|
Task-oriented Training is a functional, client-centered therapeutic approach that involves practicing meaningful and goal-directed activities aimed at enhancing performance in daily occupations. It is based on principles of motor learning and activity-specific training, offering practical solutions to restore physical function and task participation (Strong, 1998). In recent years, studies have shown that Task-oriented Training improves activity tolerance, reduces functional limitations, and fosters independence in patients with musculoskeletal conditions, including low back pain ( Monticone et al., 2016). Cognitive Behavioral Therapy , on the other hand, is a well established psychological intervention targeting maladaptive beliefs, negative thought patterns, and avoidance behaviors associated with chronic pain. It is particularly effective in reducing fear avoidance, catastrophizing, depression, and anxiety, all of which are prevalent in chronic Low Back Pain populations. Cognitive Behavioral Therapy has been shown to enhance pain coping skills, self-efficacy and participation in occupational activities by addressing the psychosocial barriers that perpetuate disability (Cherkin et al., 2016; Newton-John et al., 1995). Emerging literature suggests that combining physical activity-based interventions like Task-oriented Training and Cognitive Behavioral Therapy may produce superior outcomes in the management of chronic Low Back Pain. Integrating physical rehabilitation with cognitive restructuring strategies addresses both the biomechanical and psychosocial contributors to pain and disability (Pincus et al., 2015; Lindgreen et al., 2016). Such a multidimensional, patient-centered approach is recommended in contemporary pain management guidelines and aligns with the biopsychosocial model of care. Despite the growing body of evidence supporting both Task-oriented Training and Cognitive Behavioral Therapy individually in the management of chronic Low Back Pain, there is limited research examining their combined effectiveness on occupational performance, which is a core outcome of interest in rehabilitation. |