Comparison of the effects of therapeutic exercise with either an educational booklet or vitamin-D3 supplement in the management of chronic low back pain: study protocol for an assessor blinded multicenter randomized clinical trial

Background: It is important to know the best intervention approach to replenish serum vitamin D levels along with therapeutic interventions for chronic low back pain (CLBP) patients. From the researcher’s knowledge, no study compared “vitamin D supplement” or “booklet education on sun exposure, nutrition and lifestyle” with therapeutic exercise for CLBP cases. Researchers hypothesize that multidimensional comprehensive management of therapeutic exercise and an education booklet (TEB) on sun exposure, nutrition, and lifestyle might be superior to therapeutic exercise and oral vitamin D supplement (TED) for CLBP patients with vitamin D deficiency. Methods: We planned for an assessor-blinded two-arm multicenter Randomized Clinical Trial (RCT) protocol to compare the efficacy of TEB compared to TED for CLBP patients with vitamin D deficiency at 2 months and 6 months after baseline recruitment in designated centers in Dhaka city. The primary outcome measures will include pain by Brief Pain Inventory (BPI), and serum vitamin D3 level and secondary outcome measures will include disability by Ronald Morris Disability Questionnaire (RMDQ). Discussion: This study will provide evidence for an appropriate prescription for the management of CLBP patients having vitamin D deficiency. Registration: Clinical Trials Registry India (CTRI/2022/11/047074).