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CTRI Number  CTRI/2022/11/047074 [Registered on: 07/11/2022] Trial Registered Prospectively
Last Modified On: 04/11/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of Exercise, booklet and Vitamin D3 supplement for the Management of Low Back Pain. 
Scientific Title of Study   Effect of Therapeutic Exercise, Educational booklet and Vitamin D3 Supplement for the Management of Chronic Mechanical Low Back Pain. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Muhammad Shahidul Islam 
Designation  Ph.D. Student  
Affiliation  Jashore University of Science and Technology 
Address  Department of Nutrition and Food Technology Jashore University of Science and Technology



7408
Other 
Phone  01671107350  
Fax    
Email  physioshahidul1978@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Md Ashrafuzzaman Zahid Ph D 
Designation  Associate Professor  
Affiliation  Jashore University of Science and Technology 
Address  Department of Nutrition and Food Technology Jashore University of Science and Technology, Jashore-7408, Bangladesh.



7408
Other 
Phone  01718868631  
Fax    
Email  ashraf@just.edu.bd  
 
Details of Contact Person
Public Query  
Name  Professor Dr Md Sohrab Hossain Ph D 
Designation  Professor 
Affiliation  Bangladesh Health Professions Institute (BHPI) 
Address  Department of Physiotherapy Bangladesh Health Professions Institute (BHPI), CRP, Savar, Dhaka, Bangladesh.



1343
Other 
Phone  01793597681  
Fax    
Email  sohrabphysio@gmail.com  
 
Source of Monetary or Material Support  
Self funded study by Muhammad Shahidul Islam,Department of Nutrition and Food Technology Jashore University of Science and Technology, Jashore, Bangladesh-7408 
 
Primary Sponsor  
Name  Muhammad Shahidul Islam 
Address  Department of Nutrition and Food Technology Jashore University of Science and Technology  
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Bangladesh  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Bahauddin Bayzid  SAIC College of Medical Science and Technology  Physiotherapy Department, SAIC College of Medical Science and Technology, SAIC Tower, Mirpur-14, Dhaka

 		 01914625563

bayzid019@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SAIC College of Medical Science & Technology  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M959||Acquired deformity of musculoskeletal system, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Leaflet on Exercise and Nutritional advice  By leaflet important guidelines will provide for MLBP patients with low vitamin D and S. Calcium level, to help with knowing appropriate diet and healthy lifestyle to increase nutritional status as well as overall improvement of Physical and Psychological condition of the body. By Leaflet researcher will provide following advice - Leaflet: ✔ Take naturally Vitamin D3 containing food like- Milk, Cereal, Orange juice, Yogurt, Cereal, mushroom, margarine, hard-boil eggs, Sea fish like Tuna, Salmon, etc (Zaman et al., 2017). ✔ 30- 35 minutes sun exposure 11 am to 2 pm (Augustine, Madhavan, & Kulkarni, 2018; Harinarayan, Holick, Prasad, Vani, & Himabindu, 2013). ✔ 7–8-hour sleep (Gao et al., 2018). ✔ Avoid stress, smoking and maintain healthy body weight (Dean and Soderlund, 2015). ✔ Avoid alcohol consumption. ✔ Do regular physical activity.  
Intervention  Therapeutic exercise  1)Therapeutic exercise (TH): Exercises will focus on both the back pain and the nutritional status and disability minimization of the participants. Each session will continue for 25-30 minutes. Exercises are- TH.1: Postural advice- Maintain erect posture in sitting and standing, Avoid long sitting or standing, Avoid forward bending (Kim, Cho, Park, & Yang, 2015). TH.2:McKenzies directional preference includes - sustained positioning, flexion, or extension principle (most often need extension principle). Exercise will be completed in a set of 10 repetitions (Dunsford et al., 2011). TH.3:Stretching Exercises- stretching of erector spine muscle, hamstring, and triceps surae (França, Burke, Caffaro, Ramos, & Marques, 2012). TH.4:Lumbar stabilization exercises (Yoon, Lee, & Kim, 2013). TH.5:Weight-bearing aerobics exercise includes jogging, jogging with stair climbing, and 30 minutes of brisk walking. (Benedetti et al., 2018). TH.6:Heating modalities- IRR Exercise will performed for 4 weeks (3days/week). 1session per day. TH.5 will performed by patient at home. others will be performed by therapist  
Intervention  Vitamin D supplement  2) Vitamin D3 Supplement: In this study, both groups will receive a vitamin-D3 supplement, which will be provided by a research fund. The patients will be given 40,000 IU vitamin D3 capsule made by a specific pharmaceutical company of Bangladesh per week for 8 weeks. A physician will provide a chart of capsule-taking dates and time will be kept to avoid any kind of misconduct.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Mechanical low back pain: chronic pain felt in the lumbar/sacral regions and may be linked with musculo-ligamentous sprains and strains, disk displacement, and other conditions with persist for more than 3 months (ICD-10-CM-Code M54.5); Age ranges from 18 years and above; Both male and female patients; Those who will be motivated and given consent to include in the study.
 
 
ExclusionCriteria 
Details  Presence of any kind of comorbidities that can affect BMD like RA, Ankylosing Spondylitis, Osteomalacia, TB spine, etc., and any history of osteoporotic fracture; Post-menopausal women. Because menopause is marked as a common contributing factor for bone degeneration in midlife women. Usually, female lost 50% of their trabecular bone and 30% of cortical bone during their lifetime, about ½ of which is lost during the first 10 year of menopause (Finkelstein et al., 2008); Use of calcium, vitamin D3 supplement, resistance training, and high impact weight-bearing activities regularly within the past 6 months; Currently smoking or persons having a history of smoking in the last ten years; Mechanical low back pain patients related with bowel and bladder incontinence; Patients who were receiving medications that can affect BMD e.g. estrogen, progesterone, etc; History of psychiatric disorders or under psychological treatment.);Unwilling to participate.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment    
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Low back pain related information- will be measured by Visual analog scale.  4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
❖Serum calcium and vitamin-D level-By following standard protocol samples will be collected by expert persons and the researcher will collect the information from laboratory test reports.
❖Physical function-
Following things will measure to know about the physical condition of the participants,
●Nutritional status - by Mini nutritional assessment scale.
●Impact of back pain of functional activities- Oswestry low back pain disability index questionnaire (ODI).
●Risk of a worse result persistent disabling back pain- by STarT back screening tool.
❖Psychological status-
Fear avoidance beliefs questionnaire (FABQ)
 		 4 weeks 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="0" 
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)   Date Missing 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  25/11/2022 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Applicable 
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  

The main objective of the study is to find out the efficacy of therapeutic Exercise, educational booklet and Vitamin D3 Supplement for the management of chronic mechanical Low Back Pain. To achieve the objective a parallel-group randomized control trial study will be conducted. 90 participants will be taken as sample of the study. There will be 2 interventions and 1 control group, 30 participants in each group. The control group will get advice by an Leaflet and one experimental group will get Vitamin D3 prescribe by physician with some advice and another one will get  Vitamin D3 supplement with therapeutic exercise. Intervention will be provided for 4 weeks.

 
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