Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

Multicomponent Pain Self-Management in Adults With Haemophilic Arthropathy

1 oktober 2026 uppdaterad av: Rubén Cuesta-Barriuso, Investigación en Hemofilia y Fisioterapia

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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

70

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

  • Spanien
      • Madrid, Spanien
        • Spanish Federation of Haemophilia
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Manlig

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Övrig: 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.
Inget ingripande: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in pain interference from baseline to 6 months
Tidsram: 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.
Baseline and 6 months

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in pain interference immediately after the intervention
Tidsram: Baseline and immediately after Session 3

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
Tidsram: Baseline, immediately after Session 3, and 6 months

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
Tidsram: Baseline, immediately after Session 3, and 6 months

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
Tidsram: Baseline, immediately after Session 3, and 6 months

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
Tidsram: Baseline, immediately after Session 3, and 6 months

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
Tidsram: Baseline, immediately after Session 3, and 6 months

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
Tidsram: Baseline, immediately after Session 3, and 6 months

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
Tidsram: Baseline, immediately after Session 3, and 6 months

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
Tidsram: Baseline, immediately after Session 3, and 6 months

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

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Bleeding episodes and adverse events
Tidsram: From baseline to the 6-month follow-up

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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Investigación en Hemofilia y Fisioterapia

Utredare

  • Studiestol: Ruben C Cuesta-Barriuso, PhD, Universidad de Oviedo

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 mars 2027

Primärt slutförande (Beräknad)

15 december 2027

Avslutad studie (Beräknad)

30 december 2027

Studieregistreringsdatum

Först inskickad

1 oktober 2026

Först inskickad som uppfyllde QC-kriterierna

1 oktober 2026

Första postat (Faktisk)

6 oktober 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

6 oktober 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

1 oktober 2026

Senast verifierad

1 oktober 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • HemoPain-2027

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Prenumerera