Clinical trial NCT04794712: Evaluation of Pain Associated With Chronic Venous Insufficiency
Official title: The Evaluation of Pain Severity in the Lower Limb Caused by Chronic Venous Insufficiency
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Venous Insufficiency
Varicose Veins of Lower Limb
Keywords: photo plethysmography (PPG)
contact heat evoked potentials (CHEPS)
Varicose Veins
Chronic Venous Insufficiency
Ultrasound
leg pain
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2021-03-12
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have chronic venous insufficiency (Varicose veins)

Brief summary: 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

Detailed description: The study will have no interventional procedures. Participants who will be attending for routine Ultrasound scan for assessment of venous insufficiency , assessment evaluation of pain and participants meets our study's inclusion criteria will be provided with full research information, if they decide to participate. Once the routine assessment is done. Ultrasound will be performed to obtain the following parameters:

the RT (second), the PRV (cm/s) and the flow at peak reflux(mL/s) . photo plethysmography (PPG) can be used to measure the severity of the venous reflux disease time (RT).

Therefore, if advanced ultrasound applications can promise a precise, cost-effective, convenient, and repeatable results for the follow-up of CVI , it would be of an extreme benefit to use ultrasound scan diagnoses anatomy of lower limb for Chronic venous insufficiency patients rather than PPG . photoplethysmography : the non-invasive technique of assessing pressure without a needle .

assessment evaluation of pain CHEPS (contact heat evoked potentials ): a beneficial objective tool to measure small nerve fibre function CHEPS provides a clinically practical, non-invasive and objective measure, .Therefore heat pulses could be annoying for the patient .and it is cost effectetive machine and require a special training .

VAS visual analogue scale :

Subjective tool to measure the intensity of chronic and acute pain.some of this tool issue is a sensitive tool to use by patients and there is some changes in pain intensities because it is little variable

Eligibility criteria: Inclusion Criteria:

* ≥ 18 years ago
* Patient with Chronic venous Insufficiency

Exclusion Criteria:

* Pregnant patients
* Cancer
* Patients who unable to exercise
* Exclude anyone who is taking part in any other research
* Potential participants who might not adequately understand verbal explanations or written information given in English, or who have special communication needs will not be included.

Primary outcomes:
measure: Vein competency according to ultrasound and PPG parameters
timeFrame: baseline
measure: Pain sensation according to CHEPS parameters
timeFrame: baseline
Secondary outcomes:
measure: visual analogue scale (VAS)
timeFrame: baseline
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Imperial College London
state: England
Study officials:
affiliation: Academic Supervisor
name: Dr Mohammed Aslam, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: DANZIGER, N. 2008. Hypothesis on the origin of pain. Phlebolymphology, 15, 107-114.
citation: 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.
citation: 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.