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Central Sensitization in Vitamin D Deficiency

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ClinicalTrials.gov Identifier: NCT03420378
Recruitment Status : Completed
First Posted : February 5, 2018
Last Update Posted : December 20, 2018
Sponsor:
Information provided by (Responsible Party):
Marmara University

Brief Summary:
The purpose of this study is to investigate the presence of central sensitization in vitamin D deficiency and its effect on cutaneous silent period, pain, and quality of life. The secondary purpose of the study is to investigate whether a change in cutaneous silent period parameters, pain severity and neuropathic sensitization and quality of life after vitamin D replacement.

Condition or disease Intervention/treatment Phase
Vitamin D Deficiency Central Sensitisation Dietary Supplement: vitamin D Not Applicable

Detailed Description:

Vitamin D deficiency is a pandemia. Main causes of this is insufficient exposure to sunlight. Vitamin D deficiency is related to conditions like various cancers, autoimmune diseases, hypertension and growth retardation in children (1).

International Association for the study of pain has defined pain as "An unpleasant sensory and emotional experience associated with actual or potential tissue damage, or described in terms of such damage." (2). Pain lasting longer than 3 months has been deemed as chronic pain (3). Vitamin D deficiency influences various types of pain, including chronic pain (4,5,6,7).

Vitamin D influences the musculoskeletal system via the calcium-phosphorus metabolism and the receptors found in skeletal muscle cells (8). Vitamin D deficiency has been shown to decrease muscle strength, the this decrease in proximal muscles affect postural stability and can increase falls. Vitamin D deficiency also causes problems in bone mineralization, causing isolated or widespread pain in muscles, bones and joints. These patients end up getting wrong diagnoses such as fibromyalgia, osteoarthritis, inflammatory arthritis, and chronic fatigue syndrome (1,7). Vitamin D deficiency causes hyperinnervation and hypersensitivity on nerves and cause pain to be felt more intensely (5).

In a normal skeletal muscle, during an isometric contraction, a number of motor unit will be activated. These motor units produce a stable electromyography pattern and keep their own frequencies during contraction. If the nerve, tendon or a cutaneous nerve nearby is stimulated, electromyographic activity is disrupted and a bioelectric silence occurs. This is called cutaneous silent period (CSP). It is an inhibitory spinal reflex and its afferents consist of A-delta nerve fibers.

In various studies, CSP has been shown to be clinically beneficial in conditions like peripheral neuropathy, syringomyelia, Parkinson's disease, restless leg syndrome and fibromyalgia.

von Känel R et al. has investigated the effect of vitamin D deficiency on widespread pain index (WPI) and symptom severity score (SSS) and found out that it increases central sensitivity (8). In thei study, thy did not utilize any electrophysiologic objective measurements. Akyüz et al. have investigated the effect of vitamin D deficiency on chronic pain and nerve conduction studies; they have shown that vitamin D is correlated with various nerve conduction parameters while these parameters do not change after replacement (9,10).

Patients with vitamin D deficiency and healthy controls with normal vitamin D levels will be compared in terms of cutaneous silent period parameters, pain severity and neuropathic sensitization and quality of life. Cutaneous silent period parameters (duration and latency ), The Leeds Assessment of Neuropathic Symptoms & Signs and Nottingham Health Profile will be used for the assessments. Patients with vitamin D deficiency will receive vitamin D supplementation therapy. Before and after therapy, cutaneous silent period parameters, LANSS scores and Nottingham Health Profile will measured before and 8 weeks after starting vitamin D supplementation therapy.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Central Sensitization in Vitamin D Deficiency and Effect of Vitamin D Replacement on Cutaneous Silent Period
Actual Study Start Date : January 28, 2018
Actual Primary Completion Date : December 19, 2018
Actual Study Completion Date : December 19, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D

Arm Intervention/treatment
Experimental: Interventional Arm
Patients with vitamin D deficiency will receive vitamin D replacement therapy. Before and after therapy, cutaneous silent period will be measured from each upper extremity and latencies will be recorded. Their LANSS scores and Notthingham Health Profile will be recorded before and after treatment.
Dietary Supplement: vitamin D
Vitamin D replacement




Primary Outcome Measures :
  1. cutaneous silent period latency (ms) [ Time Frame: 8 weeks ]
    the brief interruption in voluntary contraction that follows strong electrical stimulation (painful) of a cutaneous nerve

  2. cutaneous silent period duration (ms) [ Time Frame: 8 weeks ]
    the brief interruption in voluntary contraction that follows strong electrical stimulation (painful) of a cutaneous nerve


Secondary Outcome Measures :
  1. Visual analog scale (VAS) of pain [ Time Frame: 8 weeks ]
    line from 0: no pain to 10:worst pain

  2. Leeds assessment of neuropathic symptoms and signs (LANSS) [ Time Frame: 8 weeks ]
    Reduction of pain related to central sensitization. LANSS scale ⩾ 12 refers to "Neu- neuropathic sensitization"

  3. The Nottingham Health Profile (NHP) [ Time Frame: 8 weeks ]
    The Nottingham Health Profile is intended for primary health care, to provide a brief indication of a patient's perceived emotional, social and physical health problems. The number of questions answered "yes" in each subgroup is divided by the total number of questions in the same subgroup and the result is multiplied by 100. Each subgroup has a value of between 0 and 100, with 100 points being considered the best general QoL for the calculated subgroup and 0 points being considered as the worst QoL for the same subgroup.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Presence of widespread pain
  • Presence of vitamin D deficit

Exclusion Criteria:

  • Any contraindication of performing silent cutaneous period
  • Any contraindication for vitamin d use
  • Presence of conditions that affect cutaneous silent period like the presence of carpal tunnel syndrome and polyneuropathies
  • Defective peripheric autonomic nervous system findings
  • Not being able to write and read
  • Not being able to communicate

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03420378


Locations
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Turkey
Ozge Kenis Coskun
Istanbul, Kadikoy, Turkey, 34738
Sponsors and Collaborators
Marmara University
Investigators
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Principal Investigator: Ozge Kenis Coskun, MD Marmara Universtiy

Publications:

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Responsible Party: Marmara University
ClinicalTrials.gov Identifier: NCT03420378    
Other Study ID Numbers: 12.2017.123
First Posted: February 5, 2018    Key Record Dates
Last Update Posted: December 20, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Marmara University:
Central Sensitisation
Cutaneous Silent Period
Vitamin D Deficiency
Additional relevant MeSH terms:
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Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents