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The Evaluation of Pain Severity in the Lower Limb Caused by Chronic Venous Insufficiency
Sponsor study identifier
observational
80
1 country
1
Study Start
May 15, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
May 14, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
May 14, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Chronic venous insufficiency occurs when your leg veins don't allow blood to flow back up to your heart. Normally, the valves in your veins make sure that blood flows toward your heart. But when these valves don't work well, blood can also flow backwards. This can cause blood to collect (pool) in the legs. Chronic venous disease is a highly prevalent condition in the general population, and it has a significant impact on quality of life. While it is usually manifested by obvious signs, such as varicose veins and venous ulcers, other symptoms of the disease are less specific. Among the other symptoms, which include heaviness, swelling, muscle cramps and restless legs, pain is the symptom that most frequently compels CVeD patients to seek medical aid. However, there is a substantial discrepancy between pain severity and clinically detectable signs of CVeD, questioned by several opposing studies. Further evaluation is needed to clarify this subject, and to analyse whether pain development predicts objective tool to evaluate pain by dosflexin exercise pre surgery and post and measure the severity of pain by heat stimulation . General management of CVeD starts with advising lifestyle . pain in chronic venous insufficiency it will measure before and after treatment by using contact heat evoked potential (CHEPS) and visual dialog scale ( VAS ) to estimate the pain intensity the severity of the pain before the patient do exercise before three moths of leaser endovenous ablation procedure . 2-photo-plethysomography Non invasive technique , pp sensor emit infrared light detects changes in reflection from epiderma layer . Vessels full of blood reflect 10 times less than without blood . On dorsiflexion - pressure drops, increasing reflection in the measuring window Venous assessment the venous refill time, is shorter and typically less than 20 s
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 14, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 9, 2021
Actual (reported)March 12, 2021
Actual (reported)May 15, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
May 14, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
May 14, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Vein competency according to ultrasound and PPG parameters
Detect presence of the reflux or not
baseline
Pain sensation according to CHEPS parameters
Experience pain to heat stimulus , and the response increases with temperature into the painful range(40 to 46 degree) .
baseline
visual analogue scale (VAS)
baseline
Participants group: Group A : 20 participants with chronic venous insufficiency * 3 months exercise pre surgery * Pre-surgery evaluation * Venous reflux assessment by ultrasound and PPG * Pain assessment by CHEPS,VAS QS MCGILL * 3 months exercise post surgery * Post surgery evaluation by US, PPG, CHEPS and VAS QS MCGILL.
Participants group: Group B : 20 participants with chronic venous insufficiency * Pre-surgery evaluation * Venous reflux assessment by ultrasound and PPG * Pain assessment by CHEPS,VAS QS MCGILL * Post surgery evaluation by US, PPG, CHEPS and VAS QS MCGILL.
Participants group: Control Group C : 40 participants with chronic venous insufficiency SUBGROUP 1: WITHOUT EXERCISE 20 PARTICIPANTS * VENOUS ASSESSMENT TOOLS( U/S, PPG ) * PAIN ASSESSMENT TOOLS (CHEPS VAS, MCGILL) SUBGROUP 2: 3 MONTHS EXERCISE 20 PARTICIPANTS * VENOUS ASSESSMENT TOOLS ( U/S, PPG ) * PAIN ASSESSMENT TOOLS (CHEPS VAS, MCGILL)
Venous reflux tools Pain assessment tools
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Patients who have chronic venous insufficiency (Varicose veins)
Imperial College London
London, England, W12 0HS, United Kingdom
ALGUIRE, P. C. & MATHES, B. M. 2017. Diagnostic evaluation of lower extremity chronic ve-nous insufficiency. UpToDate. Retrieved from http://www.uptodate. com/contents/diagnostic-evaluation-of-chronic-venous-insufficiency.
Andreozzi GM, Cordova RM, Scomparin A, Martini R, D'Eri A, Andreozzi F; Quality of Life Working Group on Vascular Medicine of SIAPAV. Quality of life in chronic venous insufficiency. An Italian pilot study of the Triveneto Region. Int Angiol. 2005 Sep;24(3):272-7.
DANZIGER, N. 2008. Hypothesis on the origin of pain. Phlebolymphology, 15, 107-114.
Dr Mohammed Aslam, PhD
Academic Supervisor
First Submitted
March 9, 2021
First Posted
March 12, 2021
Study Start
May 15, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
May 14, 2022
Contact the study team to confirm eligibility.
Gujja K, Wiley J, Krishnan P. Chronic Venous Insufficiency. Interv Cardiol Clin. 2014 Oct;3(4):593-605. doi: 10.1016/j.iccl.2014.07.001. Epub 2014 Oct 2.
Reinhardt F, Wetzel T, Vetten S, Radespiel-Troger M, Hilz MJ, Heuss D, Neundorfer B. Peripheral neuropathy in chronic venous insufficiency. Muscle Nerve. 2000 Jun;23(6):883-7. doi: 10.1002/(sici)1097-4598(200006)23:63.0.co;2-t.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
May 14, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
March 12, 2021
Record last verified: 2021-03
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