| CTRI Number |
CTRI/2026/03/106938 [Registered on: 27/03/2026] Trial Registered Prospectively |
| Last Modified On: |
27/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Helping School Students Manage Pain Through Education and Exercise |
|
Scientific Title of Study
|
Effect of Pain Neuroscience Education combined with exercises on pain and quality of life in school going adolescents with chronic low back pain: A pre-post study design |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Komal K B |
| Designation |
Assistant Professor |
| Affiliation |
|
| Address |
KLE College of Physiotherapy, near Gabbur cross, Hubballi
Dharwad
KARNATAKA
580028
India |
| Phone |
9620645934 |
| Fax |
|
| Email |
drkomalkb24@kledeemeduniversity.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepa C Metgud |
| Designation |
Professor and HOD Department of Pediatric Physiotherapy |
| Affiliation |
KLE Institute of Physiotherapy, Belagaum |
| Address |
KLE Academy of Higher Education and
Research Institute of Physiotherapy
J.N.Medical College Campus,
Nehru Nagar, Belgaum,
Karnataka, India.
Belgaum
KARNATAKA
590010
India |
| Phone |
8088246710 |
| Fax |
|
| Email |
deepametgud@klekipt.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Komal K B |
| Designation |
Assistant Professor, Pediatric Physiotherapy |
| Affiliation |
|
| Address |
KLE College of Physiotherapy, Gabbur cross, Hubballi
Dharwad
KARNATAKA
580028
India |
| Phone |
9620645934 |
| Fax |
|
| Email |
drkomalkb24@kledeemeduniversity.edu.in |
|
|
Source of Monetary or Material Support
|
| KLE M R SAKHARE ENGLISH MEDIUM SCHOOL,
BEHIND BVB GYMKHANA HALL,
BESIDES KLE BVB PLAYGROUND,
VIDYANAGAR, HUBBALLI-580 031 |
|
|
Primary Sponsor
|
| Name |
Dr Komal K B |
| Address |
KLE College of Physiotherapy, near gabbur cross, Hubballi, Karnataka 580028 |
| 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 Komal K B |
KLE Hospital & Medical Research Centre |
JGMMMC of KLE Academy of Higher Education & Research, Gabbur, Hubballi, 580028.
Dharwad
KARNATAKA |
9620645934
drkomalkb24@kledeemeduniversity.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL RESEARCH AND ETHICS COMMITEE KLE VK INSTITUTE OF DENTAL SCIENCES, BELAGAVI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M709||Unspecified soft tissue disorder related to use, overuse and pressure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Pain Neuroscience Education combined with exercise |
Phase 1: To explore knowledge, attitude and cultural beliefs related to chronic low back pain in school-going adolescents.
Screening of CLBP participants will be done using a self-developed questionnaire. Participants with red flags, neurological symptoms, or extravertebral cause will be excluded followed by detailed history and examination (37). Based on number of children with CLBP, a sample of children will be administered the questionnaire to assess their knowledge, attitude, and beliefs (KAB).
The KAB questionnaire will be developed by the Principal Investigator through a literature review followed by a modified three-round Delphi process (42) to ensure cultural relevance and content validity.
Phase 2: Based on the knowledge, attitude and cultural beliefs, through literature review and “Explain pain” concept developed by Butler and Lorimer Mosele (71) a pain neuroscience education material will be developed by PI relevant to Indian culture. Followed by a modified three-round Delphi process (72) experts will scrutinize and, will do content and face validity of the material (animation video/ booklet).
Phase 3: Finally, following the establishment of validity, the developed material will be used in the present study to evaluate the effect of pain neuroscience education combined with exercises on pain and quality of life in school going adolescents with chronic low back pain.
All participants will receive culturally adapted pain neuroscience education combined with exercises under parental supervision. Pre and Post values for NPRS, KIDSCREEN 27, TSK-11 and PCS-C will be assessed.
Total duration of intervention 8 weeks. |
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
Adolescents in the age group of 13 to 16 years.
Both male and female participants.
Adolescents with non specific chronic low back pain.
Numeric Pain Rating Scale score equal to or greater than 2 centimeters.
Participants who are willing to participate in the study. |
|
| ExclusionCriteria |
| Details |
1. History of surgery in lower back
2. Severe cardiovascular or respiratory conditions limiting exercise participation
3. Diagnosed psychiatric disorders requiring active treatment
4. Participants who receive any other treatment for chronic NSLBP during the study.
5. LBP related to menstrual cycle
6. Not attending more than three intervention sessions
7. Experiencing physical problems or illnesses during the study
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| NPRS, PCS- C, TSK-11, KIDSCREEN-27 |
0,4,8 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| PCS- C, TSK-11 |
0,4,8 weeks |
|
|
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
10/04/2026 |
| 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="5"
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 (CLBP) is increasingly prevalent among school-going adolescents and negatively impacts their physical functioning, psychological well-being, academic performance, and overall quality of life. Traditional management approaches often focus primarily on physical symptoms, with limited emphasis on pain cognition and psychosocial factors.
This study aims to evaluate the effect of a Pain Neuroscience Education (PNE) program combined with structured exercise therapy on pain intensity and quality of life in adolescents with chronic low back pain. The intervention integrates education about the neurophysiology of pain—helping students understand pain mechanisms, central sensitization, and pain-related fear—with targeted therapeutic exercises to improve strength, flexibility, and functional capacity.
A pre-post study design will be used to assess changes in pain levels and quality of life before and after the intervention. Outcome measures will include standardized pain scales and validated quality-of-life questionnaires. The study is expected to provide evidence on whether combining cognitive pain education with physical rehabilitation results in improved clinical and psychosocial outcomes among school-going adolescents with CLBP.
This research may contribute to developing cost-effective, school-based, and culturally adaptable intervention strategies for managing adolescent chronic low back pain. |