Evaluation of Pain Associated With Chronic Venous Insufficiency

March 9, 2021 updated by: Imperial College London

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who have chronic venous insufficiency (Varicose veins)

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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 Names:
  • 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 Names:
  • 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 Names:
  • Pain assessment tools (contact heat evoked potential (CHEPS))

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vein competency according to ultrasound and PPG parameters
Time Frame: baseline
Detect presence of the reflux or not
baseline
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) .
baseline

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imperial College London

Investigators

  • Study Director: Dr Mohammed Aslam, PhD, Academic Supervisor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

May 15, 2021

Primary Completion (ANTICIPATED)

May 14, 2022

Study Completion (ANTICIPATED)

May 14, 2022

Study Registration Dates

First Submitted

March 9, 2021

First Submitted That Met QC Criteria

March 9, 2021

First Posted (ACTUAL)

March 12, 2021

Study Record Updates

Last Update Posted (ACTUAL)

March 12, 2021

Last Update Submitted That Met QC Criteria

March 9, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21HH6669

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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