FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2020/11/029385 [Registered on: 26/11/2020] Trial Registered Prospectively
Last Modified On: 19/11/2020
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   PREVALENCE OF LOW BACK PAIN AT TERTIARY LEVEL 
Scientific Title of Study   TO STUDY THE PREVALENCE,ETIOLOGY AND ASSOCIATED RISK FACTORS FOR LOW BACK PAIN AT A TERTIARY LEVEL INSITUTEOF SUB HIMALAYAN AREA 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nandini Sharma 
Designation  junior resident  
Affiliation  Dr RPGMC Tanda 
Address  Dr RPGMC TANDA KANGRA
DR rpgmc tanda
Kangra
HIMACHAL PRADESH
176001
India 
Phone  9459528591  
Fax    
Email  sharmanandini007@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Nandini Sharma 
Designation  junior resident  
Affiliation  Dr RPGMC Tanda 
Address  Dr RPGMC TANDA KANGRA
DR rpgmc tanda
Kangra
HIMACHAL PRADESH
176001
India 
Phone  9459528591  
Fax    
Email  sharmanandini007@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Bharti Gupta 
Designation  Associate Professor 
Affiliation  Dr RPGMC Tanda 
Address  Dr RPGMC TANDA KANGRA
DR rpgmc tanda
Kangra
HIMACHAL PRADESH
176001
India 
Phone  9418044928  
Fax    
Email  drbharti203@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesia Dr RPGMC Tanda  
 
Primary Sponsor  
Name  Dr Nandini Sharma 
Address  DEPT OF ANAESTHESIA OT COMPLEX 3RD FLOOR RPGMC TANDA 
Type of Sponsor  Other [Junior resident] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Bharti Gupta  Dr.RPGMC tanda  Department of Anaesthesia Operation theatre complex
Kangra
HIMACHAL PRADESH 		 9418044928

drbharti203@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Dr.RPGMC tanda  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Pts with low back pain 
 
ExclusionCriteria 
Details  Pts not willing
Bedridden pts
Pts with major psychiatric illness 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The results of the research is to estimate the prevalence of low back pain
To evaluate common risk factors of low back pain
To prevent acute low back pain to chronic low back pain  		 The results of the research is to estimate the prevalence of low back pain during 12 months period
To evaluate common risk factors of low back pain
To prevent acute low back pain to chronic low back pain  
 
Secondary Outcome  
Outcome  TimePoints 
etiology of low back pain
impact of low back pain on individual quality of life
to study risk factors of low back pain 		 3 months 
 
Target Sample Size   Total Sample Size="290"
Sample Size from India="290" 
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)   20/12/2020 
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="11"
Days="30" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   not applicable 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

 All patients of low back pain visiting pain clinic or OPD and willing to participate will be explained about the purpose of this study and thereafter written informed consent will be taken. A performa will be filled for all patients willing to participate. Baseline data will be elicited with questions regarding demographic characterstics, physical health, psychological health, psychosocial work environment, lifestyle factors, and sick leave. Anthropometric measurements including height and weight will be included and BMI calculated. Record of relevant investigations according to patient’s profile such as complete heamogram with erythrocyte sedimentation rate, blood sugar, renal function tests, vitamin D levels, X rays, MRI, CT scan ,TFT etc. will be entered in the performa.

 Participants will be inquired if they have any chronic disease like diabetes, hypertension, heart disease, kidney disease, cancer, arthritis, liver disease, asthma, COPD or any other chronic disease.

All the treatment received by the patient from the very first visit will be recorded. Lifestyle modification will be advised to the patients such as weight loss, correct posture during work, cessation of smoking and alcohol, diet rich in vitamin D and calcium etc. Patients will be followed up or contacted telephonically for atleast 3 months after every 2 weeks to evaluate them for any improvement in low back pain or deterioration of symptoms. Further any investigations and intervention if needed in case there is no improvement will be advised on subsequent visits.  If LBP is persisting for more than 3 months duration then it will be considered and managed as chronic low back pain.

 Low back pain severity will be measured based on 0-10 (with 0 as no pain and 10 repersenting the

worst pain) VAS. Pain severity was further categorized as:

MILD (1-3)

MODERATE (4-5)

SEVERE (6-7)

VERY SEVERE (8-9)

EXCRUCIATING PAIN (10)

 

 Socio economic status was assessed using modified kuppuswamy scale based on education, occupation

of head of family and per capita income of family.

 UPPER CLASS (Score 26-29)

 UPPER MIDDLE (Score 16-25)

 LOWER MIDDLE (Score 11-15)

 UPPER LOWER (Score 5-10)

 LOWER (below 5)

 

BMI classification:

 <18.5(underweight)

 18.5-24.9(normal range)

 25-29.9(overweight)

 >30 (obese)                   class 1 (30-34.9)       class 2 (35-39.9)           class3 (≥40)

 

 

 Severity of vitamin D will be grouped as (in ng/ml):

 PROFOUND DEFICIENCY (≤4)

 SEVERE DEFICIENCY (5-8)

 MODERATELY SEVERE DEFICIENCY (9-12)

 MODERATE DEFICIENCY (13-16)

 MARGINAL DEFICIENCY (17-20)

 

                                      

 

 

 

 

 

 

 

 

 

                                      

 

 
Close