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NOT YET RECRUITING
NCT07860632
NA

Multicomponent Pain Self-Management in Adults With Haemophilic Arthropathy

Sponsor: Investigación en Hemofilia y Fisioterapia

View on ClinicalTrials.gov

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.

Official title: Multicomponent Pain Self-Management Programme in Adults With Haemophilic Arthropathy: Protocol for a Randomised Controlled Trial

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

70

Start Date

2027-03-01

Completion Date

2027-12-30

Last Updated

2026-10-06

Healthy Volunteers

No

Interventions

OTHER

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.

Locations (1)

Spanish Federation of Haemophilia

Madrid, Spain