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
|Condition or disease||Intervention/treatment||Phase|
|Vitamin D Deficiency Central Sensitisation||Dietary Supplement: vitamin D||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||51 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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
- 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
- Visual analog scale (VAS) of pain [ Time Frame: 8 weeks ]line from 0: no pain to 10:worst pain
- 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"
- 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.
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
|Ozge Kenis Coskun|
|Istanbul, Kadikoy, Turkey, 34738|
|Principal Investigator:||Ozge Kenis Coskun, MD||Marmara Universtiy|