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Evaluation of Pain Associated With Chronic Venous Insufficiency

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ClinicalTrials.gov Identifier: NCT04794712
Recruitment Status : Not yet recruiting
First Posted : March 12, 2021
Last Update Posted : March 12, 2021
Sponsor:
Information provided by (Responsible Party):
Imperial College London

Study Description
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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

Condition or disease Intervention/treatment
Chronic Venous Insufficiency Varicose Veins of Lower Limb Device: Venous reflux tools (Ultrasound and Photo plethysmography (PPG))

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

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Months
Official Title: The Evaluation of Pain Severity in the Lower Limb Caused by Chronic Venous Insufficiency
Estimated Study Start Date : May 15, 2021
Estimated Primary Completion Date : May 14, 2022
Estimated Study Completion Date : May 14, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD Varicose Veins

Groups and Cohorts
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Group/Cohort Intervention/treatment
Study group A

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))
Venous reflux tools Pain assessment tools
Other Name: Pain assessment tools (contact heat evoked potential (CHEPS))
Study group B

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))
Venous reflux tools Pain assessment tools
Other Name: Pain assessment tools (contact heat evoked potential (CHEPS))
Study Group C

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))
Venous reflux tools Pain assessment tools
Other Name: Pain assessment tools (contact heat evoked potential (CHEPS))


Outcome Measures
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Primary Outcome Measures :
  1. Vein competency according to ultrasound and PPG parameters [ Time Frame: baseline ]
    Detect presence of the reflux or not

  2. Pain sensation according to CHEPS parameters [ Time Frame: baseline ]
    Experience pain to heat stimulus , and the response increases with temperature into the painful range(40 to 46 degree) .


Secondary Outcome Measures :
  1. visual analogue scale (VAS) [ Time Frame: baseline ]
    measure the intensity of chronic pain


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who have chronic venous insufficiency (Varicose veins)
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.
Contacts and Locations
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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): NCT04794712


Contacts
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Contact: Dr Mohammed Aslam, PhD +44 20 3313 1541 m.aslam@imperial.ac.uk
Contact: Bedor K Alsoliman, MSc + 44 7380900066 b.alsoliman18@imperial.ac.uk

Locations
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United Kingdom
Imperial College London
London, England, United Kingdom, W12 0HS
Contact: Dr Mohammed Aslam, PhD    +44 2083831541    m.aslam@imperial.ac.uk   
Contact: Bedor K Alsoliman, MSc    + 44 7380900066    b.alsoliman18@imperial.ac.uk   
Sponsors and Collaborators
Imperial College London
Investigators
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Study Director: Dr Mohammed Aslam, PhD Academic Supervisor
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:
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.
DANZIGER, N. 2008. Hypothesis on the origin of pain. Phlebolymphology, 15, 107-114.
GUJJA, K., SANINA, C. & WILEY, J. M. 2017. Chronic venous insufficiency. Interventional Cardiology: Principles and Practice, 759-767.

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Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT04794712    
Other Study ID Numbers: 21HH6669
First Posted: March 12, 2021    Key Record Dates
Last Update Posted: March 12, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Imperial College London:
photo plethysmography (PPG)
contact heat evoked potentials (CHEPS)
Varicose Veins
 Chronic Venous Insufficiency
Ultrasound
leg pain
Additional relevant MeSH terms:
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Venous Insufficiency
Varicose Veins
Vascular Diseases
Cardiovascular Diseases