| CTRI Number |
CTRI/2020/03/024010 [Registered on: 17/03/2020] Trial Registered Prospectively |
| Last Modified On: |
12/03/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Back muscle activity in low back pain patients |
|
Scientific Title of Study
|
Comparison of Flexion Relaxation Phenomenon among Individuals with Recurrent low back pain during asymptomatic phase with Healthy Individuals |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shetty Shrija Jaya |
| Designation |
First Year MPT |
| Affiliation |
Manipal College Of Health Professions |
| Address |
Department Of Physiotherapy,
Manipal College Of Health Professions, Manipal Academy Of Higher Education, Manipal, Udupi, Karnataka-576104
Udupi
KARNATAKA
576104
India |
| Phone |
8861871688 |
| Fax |
|
| Email |
shettyshrija@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mr Ganesh Balthillaya M |
| Designation |
Assistant Professor (Senior Scale) |
| Affiliation |
Manipal College Of Health Professions |
| Address |
Department Of Physiotherapy,
Manipal College Of Health Professions, Manipal Academy Of Higher Education, Manipal, Udupi, Karnataka-576104
Udupi
KARNATAKA
576104
India |
| Phone |
9448263631 |
| Fax |
|
| Email |
ganesh.bm@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Mr Ganesh Balthillaya M |
| Designation |
Assistant Professor (Senior Scale) |
| Affiliation |
Manipal College Of Health Professions |
| Address |
Department Of Physiotherapy,
Manipal College Of Health Professions, Manipal Academy Of Higher Education, Manipal, Udupi, Karnataka-576104
Udupi
KARNATAKA
576104
India |
| Phone |
9448263631 |
| Fax |
|
| Email |
ganesh.bm@manipal.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Shetty Shrija Jaya |
| Address |
Department Of Physiotherapy, Manipal College Of Health Professions, Manipal Academy Of Higher Education, Manipal, Udupi, Karnataka-576104 |
| 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 |
| Shetty Shrija Jaya |
101, N1 block, Physiotherapy OPD,Department Of Physiotherapy, Kasturba Hospital, Manipal |
Kasturba Hospital, Manipal
Udupi
KARNATAKA |
8861871688
shettyshrija@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M539||Dorsopathy, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Low back pain and discomfort localized above the inferior gluteal folds and below the costal margins with or without leg pain, single or primary complaint of recurrent low back pain, supine Straight leg raise should be negative
|
|
| ExclusionCriteria |
| Details |
Clinically meaningful spinal deformities, history of surgeries of lumbar and back, severe comorbidities such as cardiovascular disease prohibiting full trunk flexion, fracture and osteoporosis of spine, Metabolic and malignant bone disease, pregnancy
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Flexion Relaxation Ratio |
cross sectional one time study during low back pain |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Numeric Pain Rating Scale, Oswestry Disability Index |
cross sectional one time study during low back pain |
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
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)
|
26/03/2020 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a cross-sectional observational study. The primary objective of this study is to compare the flexion relaxation phenomenon during the asymptomatic phase in recurrent low back pain individuals with normal healthy individuals. Twenty eight individuals in each group will be recruited based on the inclusion and exclusion criteria. Primary outcome of this study is Flexion relaxation ratio which will be assessed using Surface Electromyography and Inclinometer at one time point. Severity of Pain and Perceived Disability will be measured using Numeric Pain Rating Scale and Oswestry Disability Index for recurrent low back pain individuals. Age and gender matched healthy individuals will be assessed for flexion relaxation ratio. Data will be analysed using SPSS version 16.0. Comparison of flexion relaxation ratio between asymptomatic recurrent low back pain and normal healthy individuals will be done using Independent t-test or Mann-Whitney U test. |