Effect of Exercise, booklet and Vitamin D3 supplement for the Management of Low Back Pain.

• Conditions: Acquired deformity of musculoskeletal system, unspecified,

• Registration Number: CTRI/2022/11/047074
• Lead Sponsor: Muhammad Shahidul Islam

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.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2022-04-11
• Study Start: 2022-11-25

Recruitment & Eligibility

• Status: Not Applicable
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Low back pain related information- will be measured by Visual analog scale.	4 weeks

Secondary Outcome Measures

Name	Time	Method
â–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.	â–Physical function-

Trial Locations

Locations (1)

SAIC College of Medical Science and Technology; 🇮🇳 Mirpur-14,, India

SAIC College of Medical Science and Technology

🇮🇳Mirpur-14,, India

Bahauddin Bayzid

Principal investigator

01914625563

bayzid019@gmail.com