Multicomponent Pain Self-Management in Adults With Haemophilic Arthropathy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorInvestigación en Hemofilia y Fisioterapia
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Multicomponent pain self-management programme
Other interventionThe 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.
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: Experimental groupExperimental treatment 1 intervention
Group B: No InterventionNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline and 6 monthsSecondary outcomes
1
Change in pain interference immediately after the intervention
BPI-Interference score, calculated as the mean of seven items scored from 0 to 10; higher scores indicate greater pain interference.
Time frame
Baseline and immediately after Session 32
Change in pain intensity
Pain intensity will be assessed using the BPI-Severity subscale of the Brief Pain Inventory-Short Form, calculated from its four pain-intensity items. Higher scores indicate greater pain intensity.
Time frame
Baseline, immediately after Session 3, and 6 months3
Change in kinesiophobia
Kinesiophobia will be assessed using the Spanish version of the Tampa Scale for Kinesiophobia-11SV. Higher scores indicate greater fear of movement.
Time frame
Baseline, immediately after Session 3, and 6 months4
Change in pain catastrophising
Pain catastrophising will be assessed using the Spanish version of the Pain Catastrophizing Scale. Higher scores indicate greater pain catastrophising.
Time frame
Baseline, immediately after Session 3, and 6 monthsOther outcomes
1
Bleeding episodes and adverse events
Bleeding episodes, clinically relevant increases in pain and adverse events reported by participants will be recorded throughout follow-up.
Time frame
From baseline to the 6-month follow-upSponsors and contacts
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Source ClinicalTrials.gov
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