| CTRI Number |
CTRI/2024/12/077992 [Registered on: 12/12/2024] Trial Registered Prospectively |
| Last Modified On: |
06/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Changes in pain, activity, stress according to the level of pain in reduced spinal column space. |
|
Scientific Title of Study
|
Differences in Pain, Disability, Psychological Factors according to the Grade of Chronification in Lumbar Spinal Stenosis: A Cross-sectional 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 |
Deeksha Nuka |
| Designation |
post graduate student |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Upper basement, Department of Physiotherapy, Manipal Hospital, No 98, Rustam Bagh, Old Airport Road, Bangalore, Karnataka
Bangalore
KARNATAKA
560017
India
Bangalore
KARNATAKA
560017
India |
| Phone |
8097115125 |
| Fax |
|
| Email |
deeksha.reddy0899@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Karvannan H |
| Designation |
Head and Associate Professor |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Physiotherapy, Manipal Hospital #98, HAL, Old
Airport Road, Bangalore Karnataka 560017, India
Bangalore
KARNATAKA
560017
India
Bangalore
KARNATAKA
560017
India |
| Phone |
9986565966 |
| Fax |
|
| Email |
karvannan.h@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Karvannan H |
| Designation |
Head and Associate Professor |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Physiotherapy, Manipal Hospital #98, HAL, Old
Airport Road, Bangalore Karnataka 560017, India
Bangalore
KARNATAKA
560017
India
Bangalore
KARNATAKA
560017
India |
| Phone |
9986565966 |
| Fax |
|
| Email |
karvannan.h@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy, Manipal Hospital #98, HAL, Old Airport Road, Bangalore,
Karnataka 560017 |
|
|
Primary Sponsor
|
| Name |
Manipal Academy of Higher Education |
| Address |
Department of Physiotherapy, Manipal Hospital #98, HAL, Old
Airport Road, Bangalore Karnataka 560017, India
Bangalore
KARNATAKA
560017
India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Deeksha Nuka |
Manipal Hospitals |
Ground Floor, Manipal
Comprehensive Spine
Care Center, Manipal
Institute of Robotic
Spine Surgery. Manipal
Hospitals Bangalore,
#98, HAL, Old Airport
Road, Bangalore,
Karnataka 560017,
India
Bangalore
KARNATAKA
Bangalore
KARNATAKA |
8097115125
deeksha.reddy0899@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical Committee of Manipal Hospitals |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M498||Spondylopathy in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Low back pain as a result of Lumbar Spinal Stenosis for more than 6 weeks.
Participants diagnosed with Lumbar Spinal Stenosis at single or multi levels.
With stenosis Grade A to D based on the degree of separation of the cauda equina on T2-weighted axial images
Participants with the symptoms of LSCS include pain in the groin, hips, and buttocks, and numbness or weakness in the legs and lower back.
Symptoms usually worsen with walking or standing (claudication)
Both genders will be included |
|
| ExclusionCriteria |
| Details |
pregnancy.
more than 1 year post-natal,
A history of having neurological, respiratory, circulatory, severe orthopedic or internal diseases, tumors
No back surgery
No previous cognitive exercise therapy for their low back pain
No use of antidepressants or analgesics except for NSAID’s or paracetamol, taken two weeks prior to the testing |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain Severity and Disability using Zurich Claudication questionnaire |
Immediate Observation Only at Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Psychological Status using Hospital Anxiety and depression scale |
Immediate Observation Only at Baseline |
| Pain Catastrophizing scale |
Immediate Observation Only at Baseline |
| Pain Anxiety symptom scale |
Immediate Observation Only at Baseline |
|
|
Target Sample Size
|
Total Sample Size="82"
Sample Size from India="82"
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)
|
24/12/2024 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Studies have highlighted the correlation between psychological factors and
the experience of pain, disability, and limitations in activities of daily living
(ADL) in individuals with Lumbar Spinal Stenosis. Depression and fear of movement were the
most powerful predictors for limitations in participation in social life and pain
interference, while the severity of stenosis contributed to the prediction of
Activities of Daily Living requiring lower extremity functioning. Therefore, psychological factors
play a significant role in the experience of pain and disability in Lumbar Spinal Stenosis. |