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Clinical Trials in Spain / NCT07860632
Starting soon Not applicable

Multicomponent Pain Self-Management in Adults With Haemophilic Arthropathy

NCT07860632 · tracked via the Priya Life Science Spain tracker
Sponsor
Investigación en Hemofilia y Fisioterapia
Phase
Not applicable
Started
2027-03-01
Last updated
2026-10-06

Condition(s) studied

Hemophilic ArthropathyChronic PainHemophilia AHemophilia B

Investigational drug(s) / intervention(s)

Multicomponent pain self-management programme

Multicomponent pain self-management programme: The intervention comprises three structured face-to-face group sessions. Content includes pain neurobiology and modulation; distinctions between nociception, pain and tissue damage; biopsychosocial and fear-avoidance models; emotional regulation; diaphragmatic breathing; mindfulness; acceptance and resilience; physical activity; identification of maladaptive beliefs and cognitive distortions; cognitive restructuring; self-instruction; guided imagery; physiological de-arousal; and development of an individual self-management plan. Participants will also receive digital educational materials and between-session home assignments. A standardised safety pathway for suspected acute haemarthrosis will be included.

Study summary

Background: Haemophilic arthropathy is associated with chronic pain, functional limitation and impaired quality of life. Pain interference may also be influenced by cognitive, emotional and behavioural factors. Evidence for structured multicomponent pain self-management programmes specifically tailored to adults with haemophilic arthropathy remains limited.

Objective: To evaluate the effectiveness of a structured multicomponent pain self-management programme, compared with usual care, in reducing pain interference in adults with haemophilia A or B, haemophilic arthropathy and chronic pain.

Methods: Approximately 70 adults will be individually randomised in a 1:1 ratio to a multicomponent pain self-management programme or usual care. The intervention will comprise three 60-minute face-to-face group sessions delivered over approximately 6-8 weeks. The programme will integrate pain education, emotional-regulation training and cognitive-behavioural self-management strategies. Assessments will be performed at baseline, immediately after the intervention and at 6 months. The primary outcome will be the between-group difference in change in Brief Pain Inventory-Interference score from baseline to 6 months.

Eligibility

Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Age 18 years or older. * Diagnosis of haemophilia A or B. * Haemophilic arthropathy previously diagnosed and documented by the participant's haemophilia treatment centre. * Persistent or recurrent pain for at least 3 months in one or more affected joints. * Sufficient capacity to understand the programme content, follow study instructions and complete the assessment instruments. * Ability to provide written informed consent. * Sufficient understanding of Spanish to complete the study procedures and questionnaires. Exclusion Criteria: * Neurological or cognitive impairment that interferes with understanding of the intervention or completion of assessments. * Musculoskeletal surgery within the 2 months preceding inclusion. * Acute bleeding episode or acute musculoskeletal event within the 4 weeks preceding baseline assessment that would preclude valid completion of the assessment. * Concurrent participation in another structured educational or psychological intervention programme specifically targeting pain. * Insufficient understanding of Spanish to complete the study questionnaires.

Primary outcome measure(s)

  • Change in pain interference from baseline to 6 months — Baseline and 6 months
    Pain interference will be assessed using the Brief Pain Inventory-Short Form (BPI-SF). The BPI-Interference score is calculated as the mean of seven items scored from 0 to 10, with higher scores indicating greater interference of pain with daily life. The primary outcome is the between-group difference in mean change from baseline to the 6-month follow-up.

Trial sites (1)

FacilityCityRegionStatus
Spanish Federation of Haemophilia Madrid Spain

More Investigación en Hemofilia y Fisioterapia trials in Spain

Manual Therapy in Hemophilic Arthropathy of the Ankle Recruiting
Association of Prophylactic Treatment With Treatment Burden and Psychosocial Variables in Patients With Hemophilia Recruiting
Identification of Modifiable Sleep-related Factors in Patients With Systemic Lupus Erythematosus. Starting soon
Effectiveness of an Educational Program for Pain Management in Patients With Hemophilic Arthropathy Starting soon
Incidence of Ultrasonographically Detected Articular Damage in Initially Healthy Joints of Patients With Hemophilia A Receiving Prophylactic Treatment With Emicizumab Starting soon

Other trials for the same condition

Manual Therapy in Hemophilic Arthropathy of the Ankle Recruiting
Pain Neuroscience Education for Chronic Pain Enrolling by invitation
A Long-term Study of ADYNOVI/ADYNOVATE in Participants With Haemophilia A Active, not recruiting
Effectiveness of a Digital Treatment for Adolescents with Chronic Pain Starting soon
A Clinical Study to Evaluate the Effects of NXT007 Compared to Factor VIII Prophylaxis in Participants With Hemophilia A Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07860632 on ClinicalTrials.gov ↗ ← All trials in Spain