Hemophilia ArthropathyHe-PainSitNCT03499522
Pain in Patients With Congenital Coagulopathies
An observational study of Hemophilia Arthropathy, run by Real Fundación Victoria Eugenia.
Trial summary
Introduction. The development of joint hemorrhages in patients with congenital coagulopathies favor the development of an intra-articular, degenerative and progressive lesion (hemophilic arthropathy). Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hemophilia Arthropathy
- What is being tested?
- Observational group
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2018to 1 Feb 2019
- 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 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with hemophilia attending in six hemophilia Associations into Spanish Federation of Hemophilia (Fedhemo).
Who may be able to join
- Patients with medical diagnosis of congenital coagulopathies: hemophilia A, hemophilia B, or von Willebrand's disease
- Patients over 18 years of age
- Patients in a prophylactic or on demand regimen with FVIII / FIX concentrates
- Patients that have accepted the informed consent document.
Who cannot join
- Patients with neurological or cognitive disorders that prevent the comprehension of the questionnaires
- Patients without capacity to walk autonomously or with orthosis
- Patients without access to digital media to complement the measuring instruments.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Situation and Characteristics of Pain in Patients With Congenital Coagulopathies in Spain
Introduction. The development of joint hemorrhages in patients with congenital coagulopathies favor the development of an intra-articular, degenerative and progressive lesion (hemophilic arthropathy). Pain is one of the main clinical manifestations of hemophilic arthropathy and is related to the development of disability and a worse quality of life.
Objective. Observe the characteristics of pain, coping models and the perception of quality of life in patients with congenital coagulopathies.
Read more
Study design. Observational, cross-sectional and multi-center study. Method. 80 patients with congenital coagulopathies (hemophilia A and B, and von Willebrand's disease), of legal age, will be included in the study. Patients will be recruited in six centers, from different regions of Spain. The study variables and measurement instruments used will be: pain perception (numerical pain scale, Tampa Scale of kinesiophobia and Pain Catastrophizing Scale); perception of quality of life (Short Form -36 questionnaires); anxiety (State-Trait Anxiety Questionnaire); coping strategies (Coping Strategy Questionnaire); and disease perception (Illness behaviour questionnaire and Revised Illness Perception Questionnaire). A descriptive statistical analysis of the dependent and independent variables will be carried out. In the same way, the correlations between the variables and the characteristics of the subjects will be analyzed according to age, the type of coagulopathy and the degree of sequelae.
Expected results. Observe the characteristics of pain, its coping models and its implication in the quality of life in patients with congenital coagulopathies, and evaluate the independent variables related to the perception of pain.
Read the detailed description
Objectives:
Main objective: to observe the characteristics of pain, its coping models and its implication in the quality of life in patients with congenital coagulopathies. Secondary objectives: to evaluate the degree of kinesiofobia and catastrophism in patients with congenital coagulopathies; analyze the perception of quality of life, of disease and of anxiety in patients with hemophilia and von Willebrand's disease of age; and to identify the ingestion and administration of analgesic drugs in patients with hemophilia or von Willebrand's disease for the control of pain.
Design of the investigation Describe the type of study, methodology, research variables Cross-sectional and multicentric observational study, carried out in patients with congenital coagulopathies, with the aim of knowing the characteristics of pain, its coping strategies and its implications for quality of life.
Collection of information Instruments and data collection process
- Numerical scale of pain. The patient assigns pain a numerical value between 0 and 10. With this scale pain is considered a simple one-dimensional concept and is measured only according to its intensity. The scale is discrete, not continuous.
- Short Form 36 Health Survey (SF-36). Health questionnaire that measures the quality of life related to health. Generic instrument consisting of 36 questions, covering 8 dimensions (physical functioning, physical role, body pain, general health, vitality, social functioning, emotional role and mental health of the patient).
- State-Trait Anxiety Inventory (STAI). Generic instrument that assesses the current level of anxiety and the predisposition of the person to respond to stress. It consists of two sections that let you know how you feel at a certain time and how you feel in general. The score for each scale can range from 0-30, indicating higher scores, higher levels of anxiety.
- Tampa Scale of kinesiophobia (TSK-11SV). Through this scale the fear of movement of the patients included in the study will be evaluated. This self-report measure contains 17 items on fear of movement and recurrence of a new lesion. Four of the items have a negative wording and carry an inverse notation. The scores of the different items evaluated are added to give a total score, where the highest values reflect a greater fear of injury or relapse of the same.
- Pain catastrophizing scale (PCS). Self-administered scale of 13 items used to assess the 3-dimensional pain-mapping construct: rumination, magnification and hopelessness. Low scores indicate a low catastrophization, and high values, high catastrophization.
- Coping Strategies Questionnaire (CSQ). Questionnaire composed of 42 items grouped in 7 scales of 6 items each. Each item is scored according to a scale of 7 points: deviation of attention, reinterpretation of pain sensations, ignorance of pain sensations, self-assertive coping, prayer and hope, catastrophism and increased level of activity.
Subjects of the study Number and characteristics of the sample. The inclusion criteria to participate in the present study are patients: with a medical diagnosis of congenital coagulopathies (hemophilia A and B, or von Willebrand's disease); adults; in a prophylactic or on demand regimen with FVIII / FIX concentrates; and that they have signed the informed consent document. On the other hand, those patients with: neurological or cognitive alterations that impede the comprehension of the questionnaires will be excluded from the study; inability to walk autonomously or with an orthosis; and without access to digital media to complement the measuring instruments.
It is expected to recruit a total of 80 patients for inclusion in the study. The sample size is justified with respect to the prevalence of patients with hemophilia (2039 patients with hemophilia A and B in Spain). Based on the established selection criteria (n = 678, according to the census of the Spanish Federation of Hemophilia) the sample size at the national level would be 151, with a level of confidence or 95% confidence and an expected proportion of dropouts from the fifteen%. Thus, for the 6 regions of Spain where the study will be developed, a sample of 80 patients is established for the established study period (April to December 2018).
- Conditions
- Hemophilia Arthropathy
- Being tested
- Observational group
- Keywords
- Hemophilic arthropathy, Pain, Functional Disease Present, Quality of life, Anxiety, Stress, Coping strategies
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational groupOther
The dependent variables (pain, quality of life, anxiety and coping strategies) and the outcome measures used to measure these variables will be:
- Numerical scale of pain
- Short Form 36 Health Survey [SF-36].
- State-Trait Anxiety Inventory [STAI].
- Tampa Scale of Kinesiophofia [TSK-11SV].
- Pain catastrophizing scale [PCS].
- Coping Strategies Questionnaire [CSQ].
| Study group | Role | What they receive |
|---|---|---|
| Observational group | 80 patients with congenital coagulopathies (hemophilia A and B, and von Willebrand's disease), of legal age, will be included in the study. Patients will be recruited in six centers, from different regions of Spain.
The inclusion criteria to participate in the present study are patients: with a medical diagnosis of congenital coagulopathies (hemophilia A and B, or von Willebrand's disease); adults; in a prophylactic or on demand regimen with FVIII / FIX concentrates; and that they have signed the informed consent document.
On the other hand, those patients with: neurological or cognitive alterations that impede the comprehension of the questionnaires will be excluded from the study; inability to walk autonomously or with an orthosis; and without access to digital media to complement the measuring instruments. Receives: Other: Observational group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perception of joint pain
Measurement with numerical scale of pain. The patient must assign pain to a numerical value between two extreme points (0 to 10). Although the subject is asked to use numerical values to indicate the level of pain, the use of keywords, as well as previous instructions, are necessary if the investigators expect the patient to conceptualize their pain in numerical terms. The scale is discrete, not continuous, but to perform statistical analyzes, equal intervals can be assumed between categories.
Measured: Screening visit
Secondary outcomes (5)
Perception of pain coping strategies
Measurement with Coping Strategies Questionnaire [CSQ]. Questionnaire composed of 42 items grouped in 7 scales of 6 items each, plus 2 items referring to the control exercised over pain and the ability to reduce it. Each item is scored according to a scale of 7 points (0 = never, 3 = sometimes, 6 = always). The scales included in this measuring instrument are: deviation of attention, reinterpretation of pain sensations, ignoring pain sensations, self-assertive coping, prayer and hope, catastrophism and increased level of activity.
Measured: Screening visit
Perception of quality of life
Measurement with Short Form 36 Health Survey [SF-36]. This health questionnaire is one of the most widely used, validated and translated instruments in the field of measuring the quality of life related to health. The SF-36 health questionnaire is a generic instrument consisting of 36 questions, which provides a profile of the health status and is applicable to both patients and the healthy population. The questionnaire covers 8 dimensions: physical functioning, physical role, corporal pain, general health, vitality, social functioning, emotional role and mental health of the patient.
Measured: Screening visit
Perception of anxiety
Measurement with State-Trait Anxiety Inventory [STAI]. This generic measurement instrument evaluates the current level of anxiety and the predisposition of the person to respond to stress. The STAI scale consists of two sections: the A-state scale contains 20 elements with which the patient can express how they feel at a given time and in the A-trait sscala, which also includes 20 elements, the subject can indicate how they feel. feel in general. The score for each scale can range from 0-30, indicating higher scores, higher levels of anxiety.
Measured: Screening visit
kinesiophobia
Measurement with Tampa Scale of kinesiophobia [TSK-11SV]. Through this scale the fear of movement of the patients included in the study will be evaluated. This self-report measure contains 17 items on fear of movement and recurrence of a new lesion. Four of the items have a negative wording and carry an inverse notation. The scores of the different items evaluated are added to give a total score, where the highest values reflect a greater fear of injury or relapse of the same.
Measured: Screening visit
Perception of pain catastrophizing
Measurement with Pain catastrophizing scale [PCS]. This self-administered scale of 13 items is one of the most used to assess the construct catrastofización before pain. It includes 3 dimensions: rumination, magnification and despair. The theoretical range of the instrument is between 13 and 62, indicating low scores a low catastrophization, and high values, high catastrophizing.
Measured: Screening visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2018
- Study start1 May 2018 (estimated)
- Primary completion31 Dec 2018 (estimated)
- Study completion1 Feb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemophilia ArthropathyStudies 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Real Fundación Victoria Eugenia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rubén Cuesta-Barriuso, PhD, Real Fundación Victoria Eugenia
- Investigators
- Rubén Cuesta Barriuso, Principal investigator, Royal Victoria Eugenia Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03499522
- Sponsor's protocol ID
- He-Pain Situation
- Acronym
- He-PainSit
- Status last verified
- Apr 2018
- First submitted
- 11 Apr 2018
- Last updated
- 17 Apr 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Situation and Characteristics of Pain in Patients With Congenital Coagulopathies in Spain
- ClinicalTrials.gov ID
- NCT03499522
- Acronym / sponsor ID
- He-PainSit / He-Pain Situation
- Conditions
- Hemophilia Arthropathy
- Keywords
- Hemophilic arthropathy, Pain, Functional Disease Present, Quality of life, Anxiety, Stress, Coping strategies
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Real Fundación Victoria EugeniaUniversity, hospital or other
- Study start
- 1 May 2018 (estimated)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 1 Feb 2019 (estimated)
- First posted
- 17 Apr 2018 (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.
Introduction. The development of joint hemorrhages in patients with congenital coagulopathies favor the development of an intra-articular, degenerative and progressive lesion (hemophilic arthropathy). Pain is one of the main clinical manifestations of hemophilic arthropathy and is related to the development of disability and a worse quality of life.
Objective. Observe the characteristics of pain, coping models and the perception of quality of life in patients with congenital coagulopathies.
Study design. Observational, cross-sectional and multi-center study. Method. 80 patients with congenital coagulopathies (hemophilia A and B, and von Willebrand's disease), of legal age, will be included in the study. Patients will be recruited in six centers, from different regions of Spain. The study variables and measurement instruments used will be: pain perception (numerical pain scale, Tampa Scale of kinesiophobia and Pain Catastrophizing Scale); perception of quality of life (Short Form -36 questionnaires); anxiety (State-Trait Anxiety Questionnaire); coping strategies (Coping Strategy Questionnaire); and disease perception (Illness behaviour questionnaire and Revised Illness Perception Questionnaire). A descriptive statistical analysis of the dependent and independent variables will be carried out. In the same way, the correlations between the variables and the characteristics of the subjects will be analyzed according to age, the type of coagulopathy and the degree of sequelae.
Expected results. Observe the characteristics of pain, its coping models and its implication in the quality of life in patients with congenital coagulopathies, and evaluate the independent variables related to the perception of pain.
Detailed description
Objectives:
Main objective: to observe the characteristics of pain, its coping models and its implication in the quality of life in patients with congenital coagulopathies. Secondary objectives: to evaluate the degree of kinesiofobia and catastrophism in patients with congenital coagulopathies; analyze the perception of quality of life, of disease and of anxiety in patients with hemophilia and von Willebrand's disease of age; and to identify the ingestion and administration of analgesic drugs in patients with hemophilia or von Willebrand's disease for the control of pain.
Design of the investigation Describe the type of study, methodology, research variables Cross-sectional and multicentric observational study, carried out in patients with congenital coagulopathies, with the aim of knowing the characteristics of pain, its coping strategies and its implications for quality of life.
Collection of information Instruments and data collection process
- Numerical scale of pain. The patient assigns pain a numerical value between 0 and 10. With this scale pain is considered a simple one-dimensional concept and is measured only according to its intensity. The scale is discrete, not continuous.
- Short Form 36 Health Survey (SF-36). Health questionnaire that measures the quality of life related to health. Generic instrument consisting of 36 questions, covering 8 dimensions (physical functioning, physical role, body pain, general health, vitality, social functioning, emotional role and mental health of the patient).
- State-Trait Anxiety Inventory (STAI). Generic instrument that assesses the current level of anxiety and the predisposition of the person to respond to stress. It consists of two sections that let you know how you feel at a certain time and how you feel in general. The score for each scale can range from 0-30, indicating higher scores, higher levels of anxiety.
- Tampa Scale of kinesiophobia (TSK-11SV). Through this scale the fear of movement of the patients included in the study will be evaluated. This self-report measure contains 17 items on fear of movement and recurrence of a new lesion. Four of the items have a negative wording and carry an inverse notation. The scores of the different items evaluated are added to give a total score, where the highest values reflect a greater fear of injury or relapse of the same.
- Pain catastrophizing scale (PCS). Self-administered scale of 13 items used to assess the 3-dimensional pain-mapping construct: rumination, magnification and hopelessness. Low scores indicate a low catastrophization, and high values, high catastrophization.
- Coping Strategies Questionnaire (CSQ). Questionnaire composed of 42 items grouped in 7 scales of 6 items each. Each item is scored according to a scale of 7 points: deviation of attention, reinterpretation of pain sensations, ignorance of pain sensations, self-assertive coping, prayer and hope, catastrophism and increased level of activity.
Subjects of the study Number and characteristics of the sample. The inclusion criteria to participate in the present study are patients: with a medical diagnosis of congenital coagulopathies (hemophilia A and B, or von Willebrand's disease); adults; in a prophylactic or on demand regimen with FVIII / FIX concentrates; and that they have signed the informed consent document. On the other hand, those patients with: neurological or cognitive alterations that impede the comprehension of the questionnaires will be excluded from the study; inability to walk autonomously or with an orthosis; and without access to digital media to complement the measuring instruments.
It is expected to recruit a total of 80 patients for inclusion in the study. The sample size is justified with respect to the prevalence of patients with hemophilia (2039 patients with hemophilia A and B in Spain). Based on the established selection criteria (n = 678, according to the census of the Spanish Federation of Hemophilia) the sample size at the national level would be 151, with a level of confidence or 95% confidence and an expected proportion of dropouts from the fifteen%. Thus, for the 6 regions of Spain where the study will be developed, a sample of 80 patients is established for the established study period (April to December 2018).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational group | – | Other: Observational group80 patients with congenital coagulopathies (hemophilia A and B, and von Willebrand's disease), of legal age, will be included in the study. Patients will be recruited in six centers, from different regions of Spain. The inclusion criteria to participate in the present study are patients: with a medical diagnosis of congenital coagulopathies (hemophilia A and B, or von Willebrand's disease); adults; in a prophylactic or on demand regimen with FVIII / FIX concentrates; and that they have signed the informed consent document. On the other hand, those patients with: neurological or cognitive alterations that impede the comprehension of the questionnaires will be excluded from the study; inability to walk autonomously or with an orthosis; and without access to digital media to complement the measuring instruments. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with hemophilia attending in six hemophilia Associations into Spanish Federation of Hemophilia (Fedhemo).
Key inclusion criteria (4 listed)
- Patients with medical diagnosis of congenital coagulopathies: hemophilia A, hemophilia B, or von Willebrand's disease
- Patients over 18 years of age
- Patients in a prophylactic or on demand regimen with FVIII / FIX concentrates
- Patients that have accepted the informed consent document.
Key exclusion criteria (3 listed)
- Patients with neurological or cognitive disorders that prevent the comprehension of the questionnaires
- Patients without capacity to walk autonomously or with orthosis
- Patients without access to digital media to complement the measuring instruments.
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 |
|---|---|---|
| Observational groupThe dependent variables (pain, quality of life, anxiety and coping strategies) and the outcome measures used to measure these variables will be: * Numerical scale of pain * Short Form 36 Health Survey [SF-36]. * State-Trait Anxiety Inventory [STAI]. * Tampa Scale of Kinesiophofia [TSK-11SV]. * Pain catastrophizing scale [PCS]. * Coping Strategies Questionnaire [CSQ]. | Other | Observational group |
Primary outcome
Perception of joint pain
Time frame: Screening visit
Measurement with numerical scale of pain. The patient must assign pain to a numerical value between two extreme points (0 to 10). Although the subject is asked to use numerical values to indicate the level of pain, the use of keywords, as well as previous instructions, are necessary if the investigators expect the patient to conceptualize their pain in numerical terms. The scale is discrete, not continuous, but to perform statistical analyzes, equal intervals can be assumed between categories.
5 secondary outcomes
Perception of pain coping strategies
Time frame: Screening visit
Perception of quality of life
Time frame: Screening visit
Perception of anxiety
Time frame: Screening visit
kinesiophobia
Time frame: Screening visit
Perception of pain catastrophizing
Time frame: Screening visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2018.
- 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.
Rubén Cuesta Barriuso principal investigator
Royal Victoria Eugenia Foundation
Questions about this trial
What is this clinical trial studying?
An observational study of Hemophilia Arthropathy, run by Real Fundación Victoria Eugenia.
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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 17 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rubén Cuesta Barriuso, PhD (607547274, ruben.cuestab@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perception of joint pain (time frame: Screening visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Apr 2018.