NCT07860632|Not Yet Recruiting
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Sponsor study identifier
interventional
70
1 country
1
Study Start
March 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
December 15, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 1, 2026
Actual (reported)October 6, 2026
Actual (reported)March 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 15, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Change in pain interference from baseline to 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.
Baseline and 6 months
Change in pain interference immediately after the intervention
Baseline and immediately after Session 3
Change in pain intensity
Baseline, immediately after Session 3, and 6 months
Participants will receive three face-to-face group sessions of approximately 60 minutes delivered at 3-4-week intervals over approximately 6-8 weeks. The programme integrates pain education, emotional-regulation training and cognitive-behavioural self-management strategies specifically adapted to adults with haemophilic arthropathy.
Participants will continue their usual care, including routine haematological follow-up, prescribed haemostatic and analgesic treatment and their usual physical activity, exercise or physiotherapy routines. They will not receive the structured pain self-management programme or its educational materials before completion of the 6-month follow-up. After the final 6-month assessment, they will be offered the same multicomponent programme as the experimental group.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Spanish Federation of Haemophilia
Madrid, Spain
Ruben C Cuesta-Barriuso, PhD
Universidad de Oviedo
First Submitted
October 1, 2026
First Posted
October 6, 2026
Study Start
Change in kinesiophobia
Baseline, immediately after Session 3, and 6 months
Change in pain catastrophising
Baseline, immediately after Session 3, and 6 months
Change in health-related quality of life
Baseline, immediately after Session 3, and 6 months
Bleeding episodes and adverse events
From baseline to the 6-month follow-up
Contact the study team to confirm eligibility.
March 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
December 15, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 6, 2026
Record last verified: 2026-10
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Source: ClinicalTrials.gov.
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