Multicomponent Pain Self-Management in Adults With Haemophilic Arthropathy

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

Study Overview

• Status: Not yet recruiting
• Conditions: Hemophilia A; Hemophilia B; Chronic Pain; Hemophilic Arthropathy
• Intervention / Treatment: Other: Multicomponent pain self-management programme

Detailed Description

This is a superiority, individually randomised, partially nested controlled trial with two parallel groups and a 1:1 allocation ratio. Participants allocated to the experimental arm will receive a structured multicomponent pain self-management programme delivered in three educational cohorts of approximately 11-12 participants. The control group will continue with usual care during the 6-month study period.

The intervention will comprise three face-to-face sessions of approximately 60 minutes delivered at 3-4-week intervals. It will integrate education on pain neurobiology and modulation, emotional-regulation training and cognitive-behavioural coping strategies. Content will be specifically adapted to haemophilic arthropathy, including education on distinguishing persistent pain from symptoms suggestive of acute haemarthrosis and a standardised safety pathway for suspected bleeding.

Participants in the control group will continue routine haematological follow-up, prescribed haemostatic and analgesic treatment and their usual physical activity, exercise or physiotherapy. Following completion of the 6-month assessment, control participants will be offered the same multicomponent programme.

Outcomes will be assessed at baseline, immediately after the third intervention session and at 6 months. The primary outcome will be pain interference assessed using the Brief Pain Inventory-Short Form. Secondary outcomes will include pain intensity, kinesiophobia, pain catastrophising, anxiety, depressive symptoms, illness perception, health-related quality of life and physical activity.

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rubén Cuesta-Barriuso, PhD; Phone Number: 0034 985103386; Email: cuestaruben@uniovi.es

Study Locations

• Spain
  • Madrid, Spain
    • Spanish Federation of Haemophilia
    • Contact: Rubén Cuesta-Barriuso, PhD; Phone Number: 0034 985 103 386; Email: cuestaruben@uniovi.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; 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.	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.
No Intervention: No Intervention; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and immediately after Session 3
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.	Baseline, immediately after Session 3, and 6 months
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.	Baseline, immediately after Session 3, and 6 months
Change in pain catastrophising	Pain catastrophising will be assessed using the Spanish version of the Pain Catastrophizing Scale. Higher scores indicate greater pain catastrophising.	Baseline, immediately after Session 3, and 6 months
Change in health-related quality of life	Health-related quality of life will be assessed using the 36-Item Short Form Health Survey (SF-36). The eight SF-36 domains and the physical and mental component summary scores will be analysed. Higher scores indicate better health-related quality of life.	Baseline, immediately after Session 3, and 6 months
Change in depressive symptoms	Depressive symptoms will be assessed using the Beck Depression Inventory-II (BDI-II), a 21-item self-report questionnaire. Higher scores indicate greater depressive symptom severity.	Baseline, immediately after Session 3, and 6 months
Change in anxiety	Anxiety will be assessed using the State-Trait Anxiety Inventory (STAI), comprising 20-item state-anxiety and 20-item trait-anxiety subscales. Higher scores indicate greater anxiety.	Baseline, immediately after Session 3, and 6 months
Change in illness perception	Illness perception will be assessed using the Brief Illness Perception Questionnaire (BIPQ), which assesses cognitive and emotional representations of illness and perceived illness threat.	Baseline, immediately after Session 3, and 6 months
Change in physical activity	Physical activity will be assessed using the International Physical Activity Questionnaire-Short Form (IPAQ-SF), with a 7-day recall period. Vigorous and moderate physical activity, walking and sedentary behaviour will be recorded according to the instrument scoring protocol.	Baseline, immediately after Session 3, and 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bleeding episodes and adverse events	Bleeding episodes, clinically relevant increases in pain and adverse events reported by participants will be recorded throughout follow-up.	From baseline to the 6-month follow-up

Collaborators and Investigators

• Sponsor: Investigación en Hemofilia y Fisioterapia
• Investigators: Study Chair: Ruben C Cuesta-Barriuso, PhD, Universidad de Oviedo

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2027
• Primary Completion (Estimated): December 15, 2027
• Study Completion (Estimated): December 30, 2027

Study Registration Dates

• First Submitted: October 1, 2026
• First Submitted That Met QC Criteria: October 1, 2026
• First Posted (Actual): October 6, 2026

Study Record Updates

• Last Update Posted (Actual): October 6, 2026
• Last Update Submitted That Met QC Criteria: October 1, 2026
• Last Verified: October 1, 2026

More Information

Terms related to this study

• Keywords: Chronic pain; Physiotherapy; Kinesiophobia; Cognitive-behavioral therapy; Hemophilic arthropathy; Pain neuroscience education; Pain catastrophizing; Pain interference; Pain self-management
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Mental Disorders; Genetic Diseases, Inborn; Hematologic Diseases; Blood Coagulation Disorders; Hemorrhagic Disorders; Genetic Diseases, X-Linked; Blood Coagulation Disorders, Inherited; Coagulation Protein Disorders; Phobic Disorders; Anxiety Disorders; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Hemic and Lymphatic Diseases; Kinesiophobia; Chronic Pain; Hemophilia A; Hemophilia B
• Other Study ID Numbers: HemoPain-2027

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No