Conditioned Pain Modulation in Patients With Hemophilia

NCT06267209 | Recruiting

• 1 other identifier: He-Modulation
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: Hemophilic arthropathy is characterized by functional alterations, disabling physical sequelae, and chronic pain. Conditioned pain modulation describes the net effect of endogenous pathways that enhance or diminish the effects of afferent noxious stimuli. Objectives: To describe conditioned pain modulation in patients with hemophilia and identify the best predictive model of conditioned pain modulation in these patients Methods: Cross-sectional cohort study. 51 patients with hemophilic arthropathy will be recruited in 3 regions of Spain. The main study variable will be the conditional pain modulation (Conditioned Pain Modulation Index, using an ischemic technique of the arm using the pain pressure threshold as a test stimulus), with age being the dependent variable. The secondary variables, estimated as modifying or confounding variables, will be kinesiophobia (Tampa Scale for Kinesiophobia), catastrophizing (Pain Catstrophizing Scale), trait and state anxiety (State-Trait Anxiety Inventory) and the main clinical, anthropometric, and sociodemographic. Expected results: Identify the degree of modulation conditioned by pain in patients with hemophilic arthropathy. Identify the best predictive model for conditioned pain modulation in these patients based on the study variables

Conditions

Hemophilia

Keywords

Haemophilia; Joint pain; Conditioned pain modulation; Kinesiophobia; Catastrophism; Anxiety

Outcome Measures

Primary Outcomes (1)

• Assess the Conditioned Pain Modulation Index

  First, we will measure the pain threshold to pressure at the base of the dorsal part of the distal phalanx of the thumb, and then we will provoke the conditioned stimulus using the ischemia test on the contralateral upper limb. For the ischemia test, a sphygmomanometer will be used and inflated to 240 mmHg. The arm will be positioned horizontally. Patients will be asked to indicate the intensity of pain on a numerical pain rating scale until a pain rating of 7/10 appears. Patients will perform resistance exercises in wrist extension by lifting a 2 kg weight up to a maximum of 45 repetitions. With the sphygmomanometer still inflated, pain detection threshold measurements will be repeated at the dorsal aspect of the distal phalanx of the thumb. The time shall not be extended beyond six minutes.

  Screening visit

Secondary Outcomes (7)

• Assess the kinesiophobia with Tampa Scale of Kinesiophofia

  Screening visit

• Assess the catastrophizing with Pain catastrophizing scale

  Screening visit

• Assess the catastrophizing with State-Trait Anxiety Inventory

  Screening visit

• Assess the joint damage with Haemophilia Joint Health Score

  Screening visit

• Assess the joint pain with visual analog scale

  Screening visit

Study Arms (1)

Observacional group

Patients will be recruited in 3 regions of Spain (Galicia, Madrid and Malaga), through the respective provincial associations and the Spanish Federation of Hemophilia. The assessment will take place at the premises of the hemophilia associations included in the study. All the evaluations will be carried out by the same physiotherapist, following the same evaluation protocol. The primary variable of the study will be the conditioned modulation of pain, being age the dependent variable. Secondary variables, estimated as modifiers or confounders, will be kinesiophobia, catastrophizing, anxiety perception, joint damage, pain intensity, functional capacity and pain threshold to pressure, and type of treatment and development of inhibitors.

Other: Observational group

Interventions

Observational group OTHER

After confirming that the patients not meet any of the exclusion criteria, dependent and confounding study variables will be assessed. Patients will be recruited in 3 regions of Spain (Galicia, Madrid and Malaga), through the respective provincial associations and the Spanish Federation of Hemophilia. The assessment will take place at the premises of the hemophilia associations included in the study. All the evaluations will be carried out by the same physiotherapist, following the same evaluation protocol. The primary variable of the study will be the conditioned modulation of pain, being age the dependent variable. Secondary variables, estimated as modifiers or confounders, will be kinesiophobia, catastrophizing, anxiety perception, joint damage, pain intensity, functional capacity and pain threshold to pressure, and type of treatment and development of inhibitors.

Observacional group

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A sample size of 51 patients with hemophilic ankle arthropathy has been estimated. The assessment will take place at the premises of the hemophilia Associations included in the study. All evaluations will be performed by the same physical therapist, following the same evaluation protocol. Given the characteristics of the study, the risks of bleeding in these patients during the evaluations should be minimized by designing a well-structured and justified protocol. Likewise, it should be emphasized that the study does not imply any change in the routines and medical management guidelines of the patient with respect to the usual clinical follow-up conditions, following the premises of the physician who usually attends the patient at his or her referral hospital.

You may qualify if:

• Patients diagnosed with hemophilia A or B.
• Patients over 18 years of age.
• Persons with a medical diagnosis of bilateral hemophilic ankle arthropathy.
• Patients with clinical assessment by Hemophilia Joint Health Score (\>4 points).
• Persons with hemophilia on prophylactic treatment with FVIII / FIX coagulation concentrates or monoclonal antibodies.
• Have signed the informed consent document.

You may not qualify if:

• Patients with neurological or cognitive alterations that prevent the comprehension of the questionnaires and physical tests.
• Patients who have had an ankle hemarthrosis in the 6 months prior to the start of the study.
• Patients who have taken analgesic or anti-inflammatory drugs in the 30 days prior to the study.
• Patients who are undergoing an intervention (physiotherapeutic or orthopedic) at the time of the study.

Sponsors & Collaborators

• Investigación en Hemofilia y Fisioterapia: lead

Study Sites (1)

University of Oviedo

Oviedo, Principality of Asturias, 33006, Spain

RECRUITING

MeSH Terms

Conditions

Hemophilia A; Arthralgia; Kinesiophobia; Anxiety Disorders

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Phobic Disorders; Mental Disorders

Central Study Contacts

Rubén Cuesta-Barriuso, PhD

CONTACT

607547274; cuestaruben@uniovi.es

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2024
• First Posted: February 20, 2024
• Study Start: May 1, 2024
• Primary Completion: June 3, 2024
• Study Completion: June 20, 2024
• Last Updated: May 24, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)