Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01764139
Other study ID # 12/LO/1689
Secondary ID 12/LO/1689
Status Terminated
Phase N/A
First received January 7, 2013
Last updated March 15, 2016
Start date March 2013
Est. completion date March 2014

Study information

Verified date March 2016
Source Mid Essex Hospital NHS Trust
Contact n/a
Is FDA regulated No
Health authority United Kingdom: National Health Service
Study type Observational

Clinical Trial Summary

Vitamin D deficiency has long been linked to musculoskeletal pain, and many other chronic disease conditions. Vitamin D is a nutrient that functions as a hormone precursor, and wide-ranging health effects are supported by the presence of vitamin D receptors in several cell types and tissues of the body (eg, lymphocytes and monocytes, brain, heart, pancreas, intestine, and placenta).In addition to its essential role of maintaining bone health, hypovitaminosis D has been implicated in the development of serious conditions, including diabetes, various types of cancer, and cardiovascular diseases.

Vitamin D is a unique prohormone that humans obtain in small amount from food, dietary supplements and largely by endogenous skin synthesis from 7-dehydrocholesterol with sunlight exposure. This endogenous synthesis produces the form vitamin D3 (cholecalciferol).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, which increasingly involve working indoors during daylight hours. This may be particularly important when combined with residence in northern latitudes and a cloudy climate.The proposed pilot study aims to identify percentage of vitamin D deficiency among knee pain patients by investigating eligible patients' blood for '25 hydroxy vitamin D'.

English speaking patients whose knee pain has not been resolved following knee arthroscopy are eligible for the study. Study will be carried out at the Broomfield hospital chronic pain department.

Duration will be around 6 months.


Description:

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


Recruitment information / eligibility

Status Terminated
Enrollment 2
Est. completion date March 2014
Est. primary completion date March 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 40 Years
Eligibility 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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Procedure:
Blood sampling


Locations

Country Name City State
United Kingdom Broomfield Hospital Chelmsford Essex

Sponsors (1)

Lead Sponsor Collaborator
Dr. S R Thanthulage

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary The percentages of Vitamin D deficiency among the knee pain patients. To identify the percentages of Vitamin D deficiency among the knee pain patients 6months No
See also
  Status Clinical Trial Phase
Completed NCT02873143 - 5 Year Follow-up of Adolescents With Knee Pain N/A
Completed NCT00752765 - The Effects of Bariatric Surgery Weight Loss on Knee Pain in Patients With Osteoarthritis of the Knee N/A
Recruiting NCT05674604 - Cryoneurolysis for Knee and Shoulder Pain in an Inpatient Setting
Terminated NCT03171168 - The Effect of AposTherapy on Knee Pain N/A
Completed NCT05221047 - A Reliability and Validity Study of Urdu Version of Knee Outcome Survey-Activities of Daily Living Scale
Terminated NCT01351558 - Exercise and Pain Sensitivity N/A
Terminated NCT00601341 - Effects of Lumbosacral Joint Mobilization/Manipulation on Lower Extremity Muscle Neuromuscular Response N/A
Completed NCT03969654 - ROSA Robot Used in Total Knee Replacement Post Market Study N/A
Completed NCT03910036 - Effect of PRP Injection After Arthroscopic Meniscal Repair in the Healing Process Phase 4
Withdrawn NCT01112319 - The Effects of the Electro, Heat and Cold -Therapy During Physiotherapy Treatment in Osteoarthritis(OA) of KNEE Phase 1
Completed NCT00662493 - A Comparison of Two Exercise Programs on Knee Motor Control Phase 2
Completed NCT03956875 - Yoga for Aromatase Inhibitor-related Knee Pain Relief in Breast Cancer Patients N/A
Completed NCT03072108 - Dietary Supplement for Joint: the OLE Study N/A
Completed NCT00923598 - Optimizing Local Anesthetic Concentration for Continuous Femoral Nerve Blocks Phase 4
Terminated NCT03970629 - ROSA Total Knee Investigational Testing Authorization Study N/A
Completed NCT00403273 - Safety and Efficacy of Botulinum Toxin A Injection in Patients With Painful Artificial Knee Arthroplasty (TKA) Phase 2
Completed NCT00745069 - Efficacy and Safety of Tapentadol Extended Release Tablets in the Treatment of Moderate to Severe Pain in Subjects With Knee Osteoarthritis Phase 2
Completed NCT03815448 - Methotrexate in the Treatment of Advanced Knee Osteoarthritis With Effusion-synovitis N/A
Recruiting NCT04084236 - The Effects of Transcutaneous Electrical Nerve Stimulation on People With Knee Osteoarthritis (OA) and or Chronic Pain N/A
Completed NCT05470244 - TENS in Post-operative Total Knee Arthroplasty Recovery and Intra-venous Analgesics Requirement N/A