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Central Sensitization in Vitamin D Deficiency

Primary Purpose

Vitamin D Deficiency, Central Sensitisation

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
vitamin D
Sponsored by
Marmara University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Vitamin D Deficiency focused on measuring Central Sensitisation, Cutaneous Silent Period, Vitamin D Deficiency

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Ozge Kenis Coskun

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Interventional Arm

Arm Description

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.

Outcomes

Primary Outcome Measures

cutaneous silent period latency (ms)
the brief interruption in voluntary contraction that follows strong electrical stimulation (painful) of a cutaneous nerve
cutaneous silent period duration (ms)
the brief interruption in voluntary contraction that follows strong electrical stimulation (painful) of a cutaneous nerve

Secondary Outcome Measures

Visual analog scale (VAS) of pain
line from 0: no pain to 10:worst pain
Leeds assessment of neuropathic symptoms and signs (LANSS)
Reduction of pain related to central sensitization. LANSS scale ⩾ 12 refers to "Neu- neuropathic sensitization"
The Nottingham Health Profile (NHP)
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.

Full Information

First Posted
January 28, 2018
Last Updated
December 19, 2018
Sponsor
Marmara University
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1. Study Identification

Unique Protocol Identification Number
NCT03420378
Brief Title
Central Sensitization in Vitamin D Deficiency
Official Title
Central Sensitization in Vitamin D Deficiency and Effect of Vitamin D Replacement on Cutaneous Silent Period
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
January 28, 2018 (Actual)
Primary Completion Date
December 19, 2018 (Actual)
Study Completion Date
December 19, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Marmara University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin D Deficiency, Central Sensitisation
Keywords
Central Sensitisation, Cutaneous Silent Period, Vitamin D Deficiency

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Interventional Arm
Arm Type
Experimental
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
vitamin D
Intervention Description
Vitamin D replacement
Primary Outcome Measure Information:
Title
cutaneous silent period latency (ms)
Description
the brief interruption in voluntary contraction that follows strong electrical stimulation (painful) of a cutaneous nerve
Time Frame
8 weeks
Title
cutaneous silent period duration (ms)
Description
the brief interruption in voluntary contraction that follows strong electrical stimulation (painful) of a cutaneous nerve
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Visual analog scale (VAS) of pain
Description
line from 0: no pain to 10:worst pain
Time Frame
8 weeks
Title
Leeds assessment of neuropathic symptoms and signs (LANSS)
Description
Reduction of pain related to central sensitization. LANSS scale ⩾ 12 refers to "Neu- neuropathic sensitization"
Time Frame
8 weeks
Title
The Nottingham Health Profile (NHP)
Description
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.
Time Frame
8 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ozge Kenis Coskun, MD
Organizational Affiliation
Marmara Universtiy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ozge Kenis Coskun
City
Istanbul
State/Province
Kadikoy
ZIP/Postal Code
34738
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
14985208
Citation
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Results Reference
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Citation
Hamilton B. Vitamin D and human skeletal muscle. Scand J Med Sci Sports. 2010 Apr;20(2):182-90. doi: 10.1111/j.1600-0838.2009.01016.x. Epub 2009 Oct 5.
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PubMed Identifier
21646368
Citation
Holick MF, Binkley NC, Bischoff-Ferrari HA, Gordon CM, Hanley DA, Heaney RP, Murad MH, Weaver CM; Endocrine Society. Evaluation, treatment, and prevention of vitamin D deficiency: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2011 Jul;96(7):1911-30. doi: 10.1210/jc.2011-0385. Epub 2011 Jun 6. Erratum In: J Clin Endocrinol Metab. 2011 Dec;96(12):3908.
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PubMed Identifier
18400738
Citation
Holick MF, Chen TC. Vitamin D deficiency: a worldwide problem with health consequences. Am J Clin Nutr. 2008 Apr;87(4):1080S-6S. doi: 10.1093/ajcn/87.4.1080S.
Results Reference
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PubMed Identifier
16095934
Citation
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PubMed Identifier
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Citation
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PubMed Identifier
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Citation
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PubMed Identifier
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Citation
Mascarenhas R, Mobarhan S. Hypovitaminosis D-induced pain. Nutr Rev. 2004 Sep;62(9):354-9. doi: 10.1111/j.1753-4887.2004.tb00061.x.
Results Reference
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
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Citation
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PubMed Identifier
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Citation
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Citation
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Central Sensitization in Vitamin D Deficiency

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