Abstract
BACKGROUND: Preliminary evidence suggests an association of hypovitaminosis D (hypo.D) with mechanical Low back ache (mLBA). AIM: This study was designed to 1. Explore the relationship of hypovitaminosis D with mLBA in the absence of other confounding factors 2. Formulate and validate an appropriate treatment protocol and 3. Explore the differences in outcomes with various oral formulations of vitamin D available in Indian market. MATERIALS & METHODS: Three randomised groups of patients with mLBA and hypo.D between 18 and 45 years of age without any co morbid conditions were studied for the effectiveness of adjunctive vit.D supplementation of 6,00,000 IUs (60,000 IUs/day for ten consecutive days) in the form of granule or nano syrup or soft gel capsule for the treatment of mLBA. Review evaluation of pain, functional disability and vit.D was done at three weeks and an additional evaluation of vit.D was done at nine months. Evaluation with 3,00,000 IUs of vit.D (60,000 IUs/day for five consecutive days) was done with nano syrup in a different cohort. RESULTS: High prevalence of hypo.D (96%) was noted in patients with mLBA. Significant improvement was noted after supplementation of vit.D. The subjects of nano syrup group have shown significantly better improvement compared to others (P < 0.000). Non obese and chronic patients have shown significantly better results than their peers. Though there was significant difference in vit.D before treatment, the difference of improvement between the genders, deficiency and insufficiency, in-door and out-door, smokers and non smoker subgroups was not significant. Seasonal variation in vit.D before and after the treatment was significant. CONCLUSION: Hypovitaminosis D can be a potential causative factor for mLBA in addition to the other known causes. Proper evaluation and adjunctive vit.D supplementation can effectively break the vicious cycle of low back ache with significant improvement in serum vit.D level, effective relief of pain and significant functional improvement without any adverse effects. Improvement in vit.D was not significantly related to its initial status and obese individuals have shown significantly lesser improvement. The results with nano syrup formulation were significantly better compared to others. Formulation based dosage adjustments assume significance in view of these results.