Evaluation of Pain Associated With Chronic Venous Insufficiency

Study Overview
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Brief Summary
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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
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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

Official Title
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The Evaluation of Pain Severity in the Lower Limb Caused by Chronic Venous Insufficiency

Conditions
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Chronic Venous Insufficiency, Varicose Veins of Lower Limb

Intervention / Treatment
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* Device: Venous reflux tools (Ultrasound and Photo plethysmography (PPG))


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study group A<br>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. | Device: Venous reflux tools (Ultrasound and Photo plethysmography (PPG))<br>* Venous reflux tools Pain assessment tools<br>* Other names: Pain assessment tools (contact heat evoked potential (CHEPS));|
| Study group B<br>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. | Device: Venous reflux tools (Ultrasound and Photo plethysmography (PPG))<br>* Venous reflux tools Pain assessment tools<br>* Other names: Pain assessment tools (contact heat evoked potential (CHEPS));|
| Study Group C<br>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) | Device: Venous reflux tools (Ultrasound and Photo plethysmography (PPG))<br>* Venous reflux tools Pain assessment tools<br>* Other names: Pain assessment tools (contact heat evoked potential (CHEPS));|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visual analogue scale (VAS) | measure the intensity of chronic pain | baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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photo plethysmography (PPG), contact heat evoked potentials (CHEPS), Varicose Veins, Chronic Venous Insufficiency, Ultrasound, leg pain