Objectives:
1) Effect of vitamin D on decreasing discogenic pain.
2) Effect of vitamin D on discogenic-associated sensory deficits
Design:
Randomized placebo-controlled double blind clinical trial.
Setting and conduct:
Out-patient neurosurgery department
Criteria-met patients will be informed about the nature of this study. Written informed consent will be obtained.
Pre-intervention studies that will be done at clinic are as follows:
1) McGill questionnaire for sensory deficits.
2) Visual analogue score for low back pain and radicular pain severity.
3) Physical examination for detecting sensory deficits.
Patients will be categorized based on their vitamin D level into three groups:
Group 1) Optimum vitamin D level (32-50ng/ml) cases.
Group 2) Deficient (less than 10ng/ml) and
Group 3) Insufficient (less than 32ng/ml) vitamin D level cases.
Each of the above-mentioned groups will be randomized based on random computer-generated numbers into 2 groups to receive either 300 000 IU vitamin D (1 ml) or distilled water (1 ml) intramuscularly.
All patients will be under conservative treatment and will be prescribed 15 mg Meloxicam capsules (daily). Our study population will be warned of severe adverse side effects of vitamin D verbally and in written forms ( nausea, vomiting, abdominal pain, metallic taste, breathing difficulties…..). They will have access to emergency department in case of of side effects occurence.
The conduction duration of this study will 15 days. After injection, patients will be contacted by phone every three day to assess their pain and sensory deficits by McGill questionnaire and Visual analogue score ( 5 times).
Final post-treatment studies that will be carried out at clinic, will be:
1) McGill questionnaire for sensory deficits.
2) Visual analogue score for low back pain and radicular pain severity.
3) Physical examination for detecting sensory deficits.
Participants eligibility criteria:
Inclusion Criteria:
1) No coexistent or preexisting spine pathology (e.g. Spondylolisis, Spondylolisthesis, Infection, Tumors, Fracture)
2) Single level lumbar disc herniation.
3) Discogenic pain duration from onset up physician evaluation: less than 8 weeks.
4) Compliance with study protocol.
5) Normal Lab studies.
Exclusion Criteria:
1) Daily supplementation intake of more than 800 IU of vitamin D.
2) Serum calcium level more than 10.5 md/dl.
3) Hypercalciuria ( spot urine calcium creatinin ratio more than 0.4)
4) Lymphoma, Sarcoidosis, TB, Hyperparathyroidism, Celiac disease, malabsorption syndromes,
5) Hx of renal stone.
6) Hx of inflammatory back pain.
7) Impaired renal function tests (GFR less than 30)
8) Impaired hepatic function tests.
9) Abnormal Serum Phosphorus, Alkaline phosphatase and Parathroid hormone values.
10) FBS more than 126.
Intervention:
Patients will receive either single-dose 300000 IU vitamin D3 (1ml) or 1 ml of distilled water intramuscularly.
Outcome measures:
1) McGill questionnaire for sensory deficits.
2) Visual anlogue score for low back pain and radicular pain severity.