CirrhosisLIVERPAINNCT06062108
Prevalence of Pain in Hospitalized Cirrhotic Patients
An observational study of Cirrhosis and Hepatic Fibrosis, run by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer at 1 site in France.
Trial summary
According to the WHO, pain is an "unpleasant sensory and emotional experience, linked to existing or potential tissue damage, or described in terms suggestive of such damage". It is a legal obligation to evaluate and take care of it (law of 03/04/2022). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cirrhosis, Hepatic Fibrosis, Pain, Acute
- What is being tested?
- Pain evaluation
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 10 Nov 2023to 4 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with a diagnosis of cirrhosis in his history, hospitalized at the Center Hospitalier de la Dracénie
Who may be able to join
- Patient with a diagnosis of cirrhosis in his history, hospitalized at the Center Hospitalier de la Dracénie;
- Patient aged 18 or over;
- Patient understanding and speaking the French language.
Who cannot join
- Patient refusal;
- Patient under legal protection (guardianship, curatorship, etc.) or legal protection;
- Pregnant, parturient or breastfeeding woman;
- Patients unable to answer questions for cognitive reasons;
- Any other reason that, in the opinion of the investigator, could interfere with the evaluation of the study objectives.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Etude de la prévalence de la Douleur Chez le Patient Cirrhotique hospitalisé
According to the WHO, pain is an "unpleasant sensory and emotional experience, linked to existing or potential tissue damage, or described in terms suggestive of such damage". It is a legal obligation to evaluate and take care of it (law of 03/04/2022). However, there are still areas where this is not addressed, particularly in cirrhotic patients (Piano V et al. 2023).
The global prevalence of cirrhosis increased by 74.53% between 1990 and 2017 (Liu YB et al, 2022, INSERM France file and Zhai M et al. 2021). In France, the prevalence of cirrhosis is estimated to be 200,000 patients (Cohorte Constances 2017; Serfaty 2019). The causes are varied: toxic (alcohol), viral (hepatitis B, C, HIV), genetic (hemochromatosis, primary biliary cirrhosis) but also iatrogenic or linked to a metabolic syndrome, non-alcoholic fatty liver disease.
Read more
The first symptoms of cirrhosis are fatigue, loss of appetite and weight, nausea and vomiting, discomfort and abdominal pain. More serious symptoms may appear such as depression, confusion, sleep disturbances, edema of the lower limbs, ascites, severe pruritus or jaundice. All of these symptoms can be the cause of the pain.
However, to date, there are no studies in France on the epidemiology of pain in patients with cirrhosis (Piano V et al. 2023, Klinge M, et al, 2018). To evaluate the prevalence of pain in cirrhotic patients hospitalized at the Center Hospitalier de la Dracénie in Draguignan. Patients hospitalized at the Dracénie CH with a diagnosis of cirrhosis in its patients will be identified in the various departments by a referring doctor who will have to contact Dr PIANO. The latter, as investigating doctor, will then be able to select the patients meeting the inclusion criteria of the protocol and the informants of the existence of the research. He will explain the study to them in detail, give them sufficient time for reflection before obtaining their oral agreement and giving them the information-no-opposition letter.
The research will require a single consultation lasting between 15 and 45 minutes.
During the visit, the patient will be asked whether or not they are experiencing pain.
Read the detailed description
The main objective of this study is to evaluate the prevalence of pain in cirrhotic patients hospitalized at the Dracénie hospital in Draguignan.
The secondary objectives of this study are as follows:
- Assess pain pattern
- Assess the intensity and chronicity of pain
- Assess the type of chronic pain
- Assess sleep in patients with chronic pain
- Assess the emotional state of patients with chronic pain
- Evaluate the quality of life of patients with chronic pain
Recruitment methods 30 participants will need to be recruited over a period of 6 months. Patients will be identified during their hospitalization at the Dracénie hospital as part of current practice. These patients must meet the inclusion criteria of the protocol to be recruited.
- Conditions
- Cirrhosis, Hepatic Fibrosis, Pain, Acute, Pain, Chronic, Pain, Neuropathic
- Being tested
- Pain evaluation
- Keywords
- cirrhosis, hepatic fibrosis, pain, evaluation or assessment, neuropathic pain, chronic pain
- Medical subject headings
- Fibrosis, Liver Cirrhosis, Acute Pain, Chronic Pain, Neuralgia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain evaluationOther
Also called Pain assessment
All included patients will have an evaluation of their pain, if they have no pain, the assessment stop with one date (pain or no pain), if they have pain, an assessment is done (localization of the pain, pain intensity), if they have a pain duration over 3 months, a DN4 questionnaire, HAD scale, ISI scale and SF-1 questionnaire is evaluated.
| Study group | Role | What they receive |
|---|---|---|
| Patients with cirrhosis | Patients hospitalized during the inclusion period with cirrhosis medical history Receives: Other: Pain evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of pain in cirrhotic patients hospitalized at the Dracénie hospital in Draguignan
The investigator ask the participant about the presence or absence of pain felt by the patient.
Measured: 1 day
Secondary outcomes (6)
Assess pain location
The pain location will be assessed using a topographic self-assessment tool used in adults
Measured: 1 day
Assess pain number
The pain location will be assessed using a topographic self-assessment tool used in adults
Measured: 1 day
Assess the intensity and chronicity of pain
The intensity of pain will be assessed by the numerical pain scale : Minimum : 0 (no pain) and Maximum : 10 (intense pain). Pain will be considered chronic if the patient has had at least one pain for more than 3 months according to the International Association for the study of Pain definition.
Measured: 1 day
Assess the type of chronic pain
The type of chronic pain will be assessed using the DN4 questionnaire, questions 1 and 2 only relating to the patient's interview. The patient's score is rated out of 7 points and the diagnosis of neuropathic pain (ND) is made if the score is equal to or greater than 3/7.
Measured: 1 day
Evaluating sleep in patients with chronic pain
The sleep of patients with chronic pain will be assessed using the "Sleep Severity Index" (ISI) sleep scale. The total score varies between 0 and 28; between 0-7 = Absence of insomnia, between 8-14 = Subclinical insomnia (mild), between 15-21 = Clinical insomnia (moderate) and between 22-28 = Clinical insomnia (severe).
Measured: 1 day
Evaluating quality of life in patients with chronic pain
Quality of life will be assessed by SF-12 questionnaire. The SF-12 questionnaire is a validated 12-item quality-of-life self-assessment scale translated into French. It is a shortened version of the Medical Outcomes Study Short-Form General Health Survey (SF-36), comprising only 12 of the 36 questions, and determines a respondent's profile in 8 domains: physical function, physical role, physical pain, general health, vitality, social functioning, emotional role and mental health.
Each question is evaluated on a scale with 3 or 5 possible response levels. Several items are grouped together to form a score for each domain, ranging from 0 to 100.
The quality of life of patients with chronic pain is assessed by the overall score obtained on the SF-12 questionnaire. A high score corresponds to a better state of health/quality of life.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2023
- Study start10 Nov 2023
- Primary completion4 Apr 2025
- Study completion4 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Virginie PIANO, MD, Study director, Centre Hospitalier de la Dracénie, Draguignan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06062108
- Sponsor's protocol ID
- 2023-CHITS-009
- Other IDs
- 2023-A01529-36
- Acronym
- LIVERPAIN
- Status last verified
- Jul 2026
- First submitted
- 19 Sep 2023
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Liu YB, Chen MK. Epidemiology of liver cirrhosis and associated complications: Current knowledge and future directions. World J Gastroenterol. 2022 Nov 7;28(41):5910-5930. doi: 10.3748/wjg.v28.i41.5910.
PubMed 36405106Zhai M, Long J, Liu S, Liu C, Li L, Yang L, Li Y, Shu B. The burden of liver cirrhosis and underlying etiologies: results from the global burden of disease study 2017. Aging (Albany NY). 2021 Jan 12;13(1):279-300. doi: 10.18632/aging.104127. Epub 2021 Jan 12.
PubMed 33436531Klinge M, Coppler T, Liebschutz JM, Dugum M, Wassan A, DiMartini A, Rogal S. The assessment and management of pain in cirrhosis. Curr Hepatol Rep. 2018 Mar;17(1):42-51. doi: 10.1007/s11901-018-0389-7. Epub 2018 Feb 22.
PubMed 29552453Marchesini G, Bianchi G, Amodio P, Salerno F, Merli M, Panella C, Loguercio C, Apolone G, Niero M, Abbiati R; Italian Study Group for quality of life in cirrhosis. Factors associated with poor health-related quality of life of patients with cirrhosis. Gastroenterology. 2001 Jan;120(1):170-8. doi: 10.1053/gast.2001.21193.
PubMed 11208726
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Etude de la prévalence de la Douleur Chez le Patient Cirrhotique hospitalisé
- ClinicalTrials.gov ID
- NCT06062108
- Acronym / sponsor ID
- LIVERPAIN / 2023-CHITS-009
- Conditions
- Cirrhosis, Hepatic Fibrosis, Pain, Acute, Pain, Chronic, Pain, Neuropathic
- Keywords
- cirrhosis, hepatic fibrosis, pain, evaluation or assessment, neuropathic pain, chronic pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Centre Hospitalier Intercommunal de Toulon La Seyne sur MerUniversity, hospital or other
- Study start
- 10 Nov 2023 (actual)
- Primary completion
- 4 Apr 2025 (actual)
- Study completion
- 4 Apr 2025 (actual)
- First posted
- 2 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
According to the WHO, pain is an "unpleasant sensory and emotional experience, linked to existing or potential tissue damage, or described in terms suggestive of such damage". It is a legal obligation to evaluate and take care of it (law of 03/04/2022). However, there are still areas where this is not addressed, particularly in cirrhotic patients (Piano V et al. 2023).
The global prevalence of cirrhosis increased by 74.53% between 1990 and 2017 (Liu YB et al, 2022, INSERM France file and Zhai M et al. 2021). In France, the prevalence of cirrhosis is estimated to be 200,000 patients (Cohorte Constances 2017; Serfaty 2019). The causes are varied: toxic (alcohol), viral (hepatitis B, C, HIV), genetic (hemochromatosis, primary biliary cirrhosis) but also iatrogenic or linked to a metabolic syndrome, non-alcoholic fatty liver disease.
The first symptoms of cirrhosis are fatigue, loss of appetite and weight, nausea and vomiting, discomfort and abdominal pain. More serious symptoms may appear such as depression, confusion, sleep disturbances, edema of the lower limbs, ascites, severe pruritus or jaundice. All of these symptoms can be the cause of the pain.
However, to date, there are no studies in France on the epidemiology of pain in patients with cirrhosis (Piano V et al. 2023, Klinge M, et al, 2018). To evaluate the prevalence of pain in cirrhotic patients hospitalized at the Center Hospitalier de la Dracénie in Draguignan. Patients hospitalized at the Dracénie CH with a diagnosis of cirrhosis in its patients will be identified in the various departments by a referring doctor who will have to contact Dr PIANO. The latter, as investigating doctor, will then be able to select the patients meeting the inclusion criteria of the protocol and the informants of the existence of the research. He will explain the study to them in detail, give them sufficient time for reflection before obtaining their oral agreement and giving them the information-no-opposition letter.
The research will require a single consultation lasting between 15 and 45 minutes.
During the visit, the patient will be asked whether or not they are experiencing pain.
Detailed description
The main objective of this study is to evaluate the prevalence of pain in cirrhotic patients hospitalized at the Dracénie hospital in Draguignan.
The secondary objectives of this study are as follows:
- Assess pain pattern
- Assess the intensity and chronicity of pain
- Assess the type of chronic pain
- Assess sleep in patients with chronic pain
- Assess the emotional state of patients with chronic pain
- Evaluate the quality of life of patients with chronic pain
Recruitment methods 30 participants will need to be recruited over a period of 6 months. Patients will be identified during their hospitalization at the Dracénie hospital as part of current practice. These patients must meet the inclusion criteria of the protocol to be recruited.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with cirrhosis | – | Other: Pain evaluationPatients hospitalized during the inclusion period with cirrhosis medical history |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with a diagnosis of cirrhosis in his history, hospitalized at the Center Hospitalier de la Dracénie
Key inclusion criteria (3 listed)
- Patient with a diagnosis of cirrhosis in his history, hospitalized at the Center Hospitalier de la Dracénie;
- Patient aged 18 or over;
- Patient understanding and speaking the French language.
Key exclusion criteria (5 listed)
- Patient refusal;
- Patient under legal protection (guardianship, curatorship, etc.) or legal protection;
- Pregnant, parturient or breastfeeding woman;
- Patients unable to answer questions for cognitive reasons;
- Any other reason that, in the opinion of the investigator, could interfere with the evaluation of the study objectives.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pain evaluationAlso: Pain assessmentAll included patients will have an evaluation of their pain, if they have no pain, the assessment stop with one date (pain or no pain), if they have pain, an assessment is done (localization of the pain, pain intensity), if they have a pain duration over 3 months, a DN4 questionnaire, HAD scale, ISI scale and SF-1 questionnaire is evaluated. | Other | Patients with cirrhosis |
Primary outcome
Prevalence of pain in cirrhotic patients hospitalized at the Dracénie hospital in Draguignan
Time frame: 1 day
The investigator ask the participant about the presence or absence of pain felt by the patient.
6 secondary outcomes
Assess pain location
Time frame: 1 day
Assess pain number
Time frame: 1 day
Assess the intensity and chronicity of pain
Time frame: 1 day
Assess the type of chronic pain
Time frame: 1 day
Evaluating sleep in patients with chronic pain
Time frame: 1 day
Evaluating quality of life in patients with chronic pain
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Background: PubMed 36405106Liu YB, Chen MK. Epidemiology of liver cirrhosis and associated complications: Current knowledge and future directions. World J Gastroenterol. 2022 Nov 7;28(41):5910-5930. doi: 10.3748/wjg.v28.i41.5910.
- Background: PubMed 33436531Zhai M, Long J, Liu S, Liu C, Li L, Yang L, Li Y, Shu B. The burden of liver cirrhosis and underlying etiologies: results from the global burden of disease study 2017. Aging (Albany NY). 2021 Jan 12;13(1):279-300. doi: 10.18632/aging.104127. Epub 2021 Jan 12.
- Background: PubMed 29552453Klinge M, Coppler T, Liebschutz JM, Dugum M, Wassan A, DiMartini A, Rogal S. The assessment and management of pain in cirrhosis. Curr Hepatol Rep. 2018 Mar;17(1):42-51. doi: 10.1007/s11901-018-0389-7. Epub 2018 Feb 22.
- Background: PubMed 11208726Marchesini G, Bianchi G, Amodio P, Salerno F, Merli M, Panella C, Loguercio C, Apolone G, Niero M, Abbiati R; Italian Study Group for quality of life in cirrhosis. Factors associated with poor health-related quality of life of patients with cirrhosis. Gastroenterology. 2001 Jan;120(1):170-8. doi: 10.1053/gast.2001.21193.
- Piano V, Bellone M, Pouymayou J. Antalgie et insuffisance hépatique : La quadrature du cercle ? Le Flyer, Nov 2023.Link provided by the sponsor.
- Cirrhose une maladie du foie inflammatoire. 13/07/2017. Consultable sur ce lien: Cirrhose ⋅ Inserm, La science pour la santé.Link provided by the sponsor.
- Serfaty L. Données de la cohorte CONSTANCES. SNFGE/AFEF 2019.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Virginie PIANO, MD study director
Centre Hospitalier de la Dracénie, Draguignan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cirrhosis and Hepatic Fibrosis, run by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of pain in cirrhotic patients hospitalized at the Dracénie hospital in Draguignan (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06062108, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.