| CTRI Number |
CTRI/2022/10/046377 [Registered on: 11/10/2022] Trial Registered Prospectively |
| Last Modified On: |
31/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Subgrouping of patients with non-specific low back pain for more than 3 months based on pain patterns |
|
Scientific Title of Study
|
Categorization of patients with chronic non-specific low back pain based on movement evoked pain and pain sensitivity |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ms Sharvari Sardeshmukh |
| Designation |
Post Graduate Student |
| Affiliation |
Manipal College Of Health Professions (MCHP) |
| Address |
Department of Physiotherapy
Manipal College Of Health Professions (MCHP)
Manipal Academy of Higher Education (MAHE)
Manipal
Udupi
Karnataka
India
576104
Udupi
KARNATAKA
576104
India |
| Phone |
9619030965 |
| Fax |
|
| Email |
sardeshmukh.vivek@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Mr Ganesh Balthillaya M |
| Designation |
Assistant Professor |
| Affiliation |
Manipal College Of Health Professions (MCHP) |
| Address |
Department of Physiotherapy
Manipal College Of Health Professions (MCHP)
Manipal Academy of Higher Education (MAHE)
Manipal
Udupi
Karnataka
India
576104
Udupi
KARNATAKA
576104
India |
| Phone |
9448263631 |
| Fax |
|
| Email |
ganesh.bm@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Mr Prateek Srivastav |
| Designation |
Assistant Professor |
| Affiliation |
Manipal College Of Health Professions (MCHP) |
| Address |
Department of Physiotherapy
Manipal College Of Health Professions (MCHP)
Manipal Academy of Higher Education (MAHE)
Manipal
Udupi
Karnataka
India
576104
Udupi
KARNATAKA
576104
India |
| Phone |
8971984556 |
| Fax |
|
| Email |
prateek.srivastav@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal College of Health Professions (MCHP) |
|
|
Primary Sponsor
|
| Name |
Manipal College Of Health Professions MCHP |
| Address |
Department of Physiotherapy
Manipal College Of Health Professions (MCHP)
Manipal Academy of Higher Education (MAHE)
Manipal
Udupi
Karnataka
India
576104 |
| 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 |
| Ms Sharvari Sardeshmukh |
Kasturba Hospital |
Department of Physiotherapy of Kasturba Hospital,
Manipal
Udupi
Karnataka
India
576104
Udupi
KARNATAKA |
9619030965
sardeshmukh.vivek@learner.manipel.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee - 2 (Student research) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M549||Dorsalgia, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients with LBP for more than 12 weeks (3months)
2) Patients who can read English and/or Kannada
3) Age: 18 to 60 years
4) Either gender |
|
| ExclusionCriteria |
| Details |
Individuals who have:
1) Recently undergone any surgery (e.g., Spinal, abdominal surgery) or diagnosed with acute serious pathology of spine (e.g., vertebral fracture)
2) Known neurological/ metabolic disorders with sensory impairments
3) Known Malignancies
4) Pregnant women |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) Baseline pain – pain intensity on NPRS (0-10)
2) Movement evoked pain – pain intensity on NPRS (0-10)
3) Sensitivity to movement evoked pain index - Change in pain with movement
4) Pain pressure threshold (PPT)
5) Wind-up ratio (WUR) - Perception of pain from repetitive stimuli (Temporal summation) |
One time assessment at the time of recruitment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Oswestry disability index (ODI)
2) PROMIS global health questionnaire short form
3) Central Sensitization Inventory (CSI)
4) Douleur Neuropathique 4 (DN4)
|
One time assessment at the time of recruitment |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
17/10/2022 |
| 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="7"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A cross-sectional study will be undertaken. Potential participants for the study will be screened for eligibility and selected on the basis of the inclusion-exclusion criteria from all patients with low back pain referred to the department of Physiotherapy, Kasturba Hospital (KH). Informed consent will be sought from those eligible to participate in the study. Baseline information including demographic data and pain characteristics (such as site, duration, frequency, intensity) will be enquired and documented. Assessment of movement evoked pain (MEP) and sensitivity to movement evoked pain (SMEP) will be performed by performing 3 tasks from Back Performance Scale (BFS) – Pickup test, Roll up test and Sock test. Pain sensitivity will be assessed using a static measure - pain pressure threshold (PPT) and a dynamic measure - temporal summation (TS). 4 questionnaires will be administered - Oswestry disability index (ODI), PROMIS global health questionnaire short form, central sensitization inventory (CSI) and Douleur Neuropathique 4 (DN4). The data obtained with be analyzed to study the statically results.
|