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Pain in Patients With Congenital Coagulopathies (He-PainSit)

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ClinicalTrials.gov Identifier: NCT03499522
Recruitment Status : Not yet recruiting
First Posted : April 17, 2018
Last Update Posted : April 17, 2018
Sponsor:
Information provided by (Responsible Party):
Rubén Cuesta-Barriuso, PhD, Real Fundación Victoria Eugenia

Brief 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). 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.


Condition or disease Intervention/treatment
Hemophilia Arthropathy Other: Observational group

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Situation and Characteristics of Pain in Patients With Congenital Coagulopathies in Spain
Estimated Study Start Date : May 1, 2018
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : February 1, 2019


Group/Cohort Intervention/treatment
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.

Other: Observational group

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].




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Perception of pain coping strategies [ Time Frame: Screening visit ]
    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.

  2. Perception of quality of life [ Time Frame: Screening visit ]
    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.

  3. Perception of anxiety [ Time Frame: Screening visit ]
    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.

  4. kinesiophobia [ Time Frame: Screening visit ]
    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.

  5. Perception of pain catastrophizing [ Time Frame: Screening visit ]
    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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with hemophilia attending in six hemophilia Associations into Spanish Federation of Hemophilia (Fedhemo).
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

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): NCT03499522


Contacts
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Contact: Rubén Cuesta Barriuso, PhD 607547274 ruben.cuestab@gmail.com

Sponsors and Collaborators
Real Fundación Victoria Eugenia
Investigators
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Principal Investigator: Rubén Cuesta Barriuso Royal Victoria Eugenia Foundation

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Responsible Party: Rubén Cuesta-Barriuso, PhD, Principal Investigator, Real Fundación Victoria Eugenia
ClinicalTrials.gov Identifier: NCT03499522     History of Changes
Other Study ID Numbers: He-Pain Situation
First Posted: April 17, 2018    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: April 2018
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 Rubén Cuesta-Barriuso, PhD, Real Fundación Victoria Eugenia:
Hemophilic arthropathy
Pain
Functional Disease Present
Quality of life
Anxiety
Stress
Coping strategies
Additional relevant MeSH terms:
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Joint Diseases
Musculoskeletal Diseases