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A clinical trial to study the effect of vitamin D on improving the pain in chronic low back pain patients.

Phase 3
Completed
Conditions
Health Condition 1: null- Chronic low back pain
Registration Number
CTRI/2014/03/004459
Lead Sponsor
Department of Science Technology Chandigarh Administration
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

Chronic low-back pain due to disc prolapse, lumbar spondylosis, and/or spinal stenosis, for at least 3 month refractory to conservative or interventional therapies, Documented low serum 25(OH)D3 levels ( < 30 ng/ml), Mean pain intensity of more than 50% by patient assessment by VAS

Exclusion Criteria

Patient of chronic low back pain having medical conditions requiring calcium or vitamin

D supplementation (i.e., osteoporosis)

Diabetes, neurological disease, History of gastric ulcers or intestinal bleeding or alcohol or drug abuse.

Evidence of renal disease (Se. creatinine > 1.5), liver disease (deranged LFT).

Pregnant and lactating mothers and women intending pregnancy.

Evidence of other causes for neuropathy and painful conditions.

Epilepsy, psychiatric and substance abuse.

Patients taking Vit-D supplements during the past three months.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
umber of patients achieving at least 50% pain relief as compared to the baseline pain intensityTimepoint: 2 months
Secondary Outcome Measures
NameTimeMethod
1. Overall VAS <br/ ><br>2. Improvement in MODQ from baseline <br/ ><br>3. Decrement in rescue medication <br/ ><br>Timepoint: Baseline and 1, 2, 3, 4 and 6 months
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