Trial Information

Vitamin D Levels In Patients Who Has Normal to Grade 2 Knee Arthroscopy Changes or Who Did Not Improve Symptoms Following Minor Knee Arthroscopic Procedures

Introduction Vitamin D deficiency has recently been linked with a range of diseases
including chronic pain. Range of vitamin D levels are classified as deficiency less than
50nmols, insufficient 50 to 75 nmols, and adequate 75 to 150 nmoles, excessive more than
150nmol. Vitamin D deficiency was also identified in some of the chronic pain patients who
presented to our pain clinic at Broomfield hospital.

Vitamin D deficiency and insufficiency are very common in the UK. Local audit at Chelmsford
has shown severe deficiency of vitamin D among chronic pain patients.

The major source of vitamin D synthesis relies on sunlight exposure which is likely to be
affected by modern lifestyles, or increasingly working indoors during daylight hours. This
may be particularly important when combined with residence in northern latitudes and a
cloudy climate.

Observational and circumstantial evidence suggests that there may be a role for vitamin D
treatment for some chronic pain conditions. Al-Jarallah &colleagues had showed that (25(OH)
D level was 11.4 ± 6.07 ng/ml.) 92.9% were vitamin D deficient among their Kuwaiti patients
with primary knee osteoarthritis (21).

Our aim is to identify how many percentages of our patients, who are having knee pain,
without any major abnormal findings are deficient of vitamin D.

If this number is significant, can we supplement them to improve their pain? If we correctly
supplement patients early enough, can we prevent further deterioration of their knee joint?
These are some of the questions we may be able to investigate and treat.

Currently the investigations of vitamin D levels were done on patients with primary knee
osteoarthritis and to assess its relation with radiological grading and functional status,
but not to assess the relationship with pain.

Research Aims, hypotheses We aim to identify incidence of vitamin D deficiency among knee
pain patients. If this proves significant, next step is to organise a trial to treat these
patients to identify the effectiveness of adequate supplementation for relieving pain. Our
aim is to investigate around 50 patients.

Recruitment English speaking patients whose knee pain has not been resolved following knee
arthroscopy will be invited to the study. Sample size will be only 50 patients. Patients
will explain the purpose of the study in plain English before the invitation. After giving
informed consent, sample of blood will be taken for '25hydroxy vitamin D' levels. Study will
be carried out at the Broomfield hospital chronic pain department.

Inclusion criteria Male & no pregnant female age between 18-40 yrs, who continue to
experience knee pain following normal to Grade 2 knee arthroscopy findings.

Exclusion Criteria Any types of anatomical or neurological causes for the pain, history of
seizures, regional pain syndrome, alcohol or drug abuse, and malignancy, patients with
clinically significant diseases and patients who do not understand English will be excluded.

Intervention or procedure One blood sample per patient.

Data management and analysis The proportion of patients with vitamin D deficiency will be
estimated from the data and the corresponding 95% confidence limits calculated using the
Wilson method. The mean and standard deviation of the vitamin D level will be estimated from
the data along with the corresponding 95% confidence limits obtained using a bootstrap with
999 samples. The statistical distribution of the vitamin D level will also be examined.

Primary outcome measure for the study To identify the percentages of Vitamin D deficiency
among the knee pain patients