| CTRI Number |
CTRI/2025/11/097886 [Registered on: 21/11/2025] Trial Registered Prospectively |
| Last Modified On: |
21/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral
Other (Specify) [Self managed psychoeducation based Pain Management Program] |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Efficacy of Self-Managed Intervention for Reducing Pain in Chronic Low Back Pain Patients |
|
Scientific Title of Study
|
Efficacy of Self managed Psychoeducation based Pain management program in Reducing Pain Intensity in Patients with Chronic 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 |
Nityanand Pandey |
| Designation |
Associate Professor |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Neurosurgery,
Institute of Medical Sciences,
Banaras Hindu University
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9555303666 |
| Fax |
|
| Email |
nityanand_pandey@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Saishree |
| Designation |
Doctoral Scholar |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Psychology,
Faculty of Social Sciences,
Banaras Hindu University
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7011709243 |
| Fax |
|
| Email |
saishree0777@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jay Kumar Ranjan |
| Designation |
Associate Professor |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Psychology,
Faculty of Social Sciences,
Banaras Hindu University
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9304153083 |
| Fax |
|
| Email |
jaykumarranjan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Monetary support received as Senior Research Fellowship (SRF) from the University Grants Commission (UGC)
The data collection for the study will be conducted in the neurosurgery OPD of Sir Sunderlal Hospital in BHU.
Room no. 17, Department of Neurosurgery, Out Patient Department (OPD), Banaras Hindu University, Varanasi, Uttar Pradesh, Pincode - 221005
|
|
|
Primary Sponsor
|
| Name |
Senior Research Fellowship (SRF) from the University Grants Commission (UGC) |
| Address |
Bahadur Shah Zafar Marg, New Delhi, Pincode - 110002, India |
| Type of Sponsor |
Government funding agency |
|
|
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 Nityanand Pandey |
Sir Sunderlal Hospital |
Room no. 17, Department of Neurosurgery, Out Patient Department (OPD), Banaras Hindu University, Varanasi, Pincode - 221005 India
Varanasi
UTTAR PRADESH |
9555303666
nityanand_pandey@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Institute of Medical Sciences, Banaras Hindu University |
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 |
| Intervention |
Self-managed Psychoeducation based Pain management Program for Chronic Low Back Pain |
The Self-managed Multidisciplinary Pain Program is an intervention program aimed at reducing pain intensity in patients with chronic low back pain. It includes psychoeducation, activity scheduling and a single-session supportive counselling to patients with CLBP.
Activity Scheduling
The activity scheduling has been crafted following the teachings of Ayurveda. The activity scheduling includes a series of routine activities that the patient is required to perform daily. This includes structured physical activities like walking and yoga techniques for relieving back pain. Additionally, the patient is introduced to fixed schedules for meals, bedtime and drinking water. Finally, consumption of tea and spicy food is restricted. These activities are to be performed daily by the patient. To ensure patient adherence the therapist will call the patient weekly as well as cooperation from the caregiver will be taken.
Supportive counselling
Supportive counselling will be provided as a single session at the start of the program. It aims to subtly influence the patient towards positive thoughts and behaviours through the techniques of suggestion. It includes providing the patient with a safe space to express their feelings, setting realistic goals and improving family support through communication. These techniques are used to reduce pain intensity experienced by the patient.
Psychoeducation
Psychoeducation is an evidence-based therapeutic intervention that combines education and psychological support to help patients to better understand and manage their health issues. In context of chronic pain management, psychoeducation plays a crucial role in providing patients with knowledge about their condition, coping strategies, and self-management techniques. For this study, the information model of psychoeducation will be used wherein the focus will be on providing the patient with information regarding their condition.
|
| Comparator Agent |
Treatment as usual |
Patients in the control group will be receiving treatment as usual for their chronic low back pain |
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
i. Patients suffering from low back pain for more than 12 weeks
ii. Cooperative patients
|
|
| ExclusionCriteria |
| Details |
i. Participants with existing pregnancy
ii. Participants with a past history of psychiatric disorders (such as anxiety, depression, PTSD)
iii. Participants with a history of spinal surgery.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Visual analogue scale (VAS) |
Upon admission (T1)
3 months (T2)
6 months (T3) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Generalized anxiety scale 7 (GAD 7) |
Upon admission (T1)
3 months (T2)
6 months (T3) |
| Roland-Morris disability questionnaire (RMDQ) |
Upon admission (T1)
3 months (T2)
6 months (T3) |
| Patient Health Questionnaire 9 |
Upon admission (T1)
3 months (T2)
6 months (T3) |
| Pain catastrophizing scale (PCS) |
Upon admission (T1)
3 months (T2)
6 months (T3) |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
31/12/2025 |
| 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
|
Chronic low back pain can substantially reduce a patient’s quality of life, affecting physical functioning, emotional well-being, and the capacity to engage in occupational and social activities. Individuals experiencing chronic low back pain often endure significant distress in their daily lives.. Additionally, patients from middle to low socioeconomic backgrounds may face challenges in attending regular sessions designed to manage their chronic low back pain, due to factors such as travel costs, limited awareness, and poor accessibility. Multiple treatment options exist for such patients that may be invasive (surgical) or non-invasive (conservative) in nature. The program offers a cost-effective, non-invasive, and accessible treatment option for these patients that incorporates psychotherapy and psychoeducation techniques. Notably, there is a paucity of research on Indian patients with chronic low back pain. The subjective pain experience of the patient may be influenced by social, psychological, and cultural factors, necessitating more studies within the Indian context |