Psychology and Physiotherapy Approach of Chronic Pain in Patients With Hemophilia

Instituto de Investigacion Sanitaria La Fe19 enrolled

Overview

This study evaluates the clinical impact of a combined protocol with cognitive-behavioral intervention and physiotherapy adjuvant to the standard medical treatment in patients with haemophilia that suffer from chronic pain

The purpose of this study is to improve the perception of the experience of chronic pain, as well as functionality and quality of life in hemophilic patients with chronic pain Secondary objectives are: * to change the perception that the patient has of their pain, to improve the coping strategies and to increase the perception of self-efficacy of patients in pain management. * to increase the resources that allow a better self-regulatory of emotional, cognitive and competential of the pain experience, reverting in the emotional state of patients, particularly in levels of anxiety and depression. * to improve functional capacity and musculoskeletal status. * to improve quality of life. * to determine whether changes / improvements are maintained over time 3 months after finishing the program

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Haemophilia

Interventions

Psychology and Physiotherapy groupOTHER

Psychological program: 4 sessions,2 hours each,4 months * Psychoeducation.Influence of psychological factors on chronic pain: modulators of pain experience. Biopsychosocial model of pain. * Training techniques of psychological management of pain:Diaphragmatic Breathing and Progressive Muscle Relaxation to control vicious circle pain-tension-pain. * Kinesiophobia. Rational regulation of the activity level:Cognitive therapy (management of irrational believes about pain) and Organisation of time and reinforcement activities. Physiotherapy program:3 sessions per week,1 hour per session,4 months: * Aerobic exercise:walking, cycling * Warm-up: active ROM exercises of inferior and superior extremities (ISE) * Progressive resistance training with elastic bands of ISE * Stretching of ISE

Placebo comparator: control groupOTHER

Control group Normal daily activities Usual daily activities

Eligibility

Sex: MALEMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosis of haemophilia A or B. * Age between 18 and 60 years. * Informed consent signed. * Signs of arthropathy according to clinical criteria (score Gilbert) and / or radiological criteria (score Pettersson) in at least one of the six joints most commonly affected (ankles, knees or elbows) * Chronic pain (CP) defined as persistent pain lasting at least six months and resistant to conventional medical therapy. It differs from the acute pain not only in its longer duration, but also sometimes persists even after the cause that produced it has disappeared. * Absence of active coping strategies, understanding the concept of coping as those cognitive and behavioral efforts made by the individual in order to manage internal and external demands generated by their chronic pain condition and that involve a challenge to their potential individual resources. Exclusion Criteria: * Presence of inhibitor to FVIII or FIX. * Another haemostatic defect. * Patients with severe cognitive deficits with which it is not possible a cognitive psychological intervention. * The inability to attend physiotherapy sessions for 12 consecutive weeks (7 supervised and 31 self-monitored) * Surgical procedures performed 6 weeks prior or during the intervention protocol. * Not acceptance or withdrawal of informed consent

Locations (1)

Instituto de Investigación Sanitaria La Fe. Hospital Universitari i Politècnic La Fe

Valencia, Spain

Outcomes

Primary Outcomes

Changes in Perceived Self-efficacy: Chronic Pain Self-Efficacy Scale Spainsh Version. (Martín-Aragon et al., 1999).

The scale contain 3 Subscales: Self-efficacy in the control of symptoms (score 0-80); Self-efficacy in physical functioning (score 0-60) and Self-efficacy in pain management (score 0-50). Total Score: 0-190 and higher values represent a better outcome (more Self-Efficacy perceived).

Time frame: baseline, 4 months, 7 months

Secondary Outcomes

Quality of Life related with health

Measured by a Specific questionnaire for Quality of Life related with health evaluation for adults with haemophilia (A36Haemophilia-QoL), which explores 9 areas. Subscales and score range: Physical health: 0-32; Daily activities: 0-16; Joints: 0-12; Pain: 0-8; Treatment satisfaction: 0-8; Difficulties treatment: 0-16; Emotional functioning: 0-20; Mental health: 0-12; Social activity: 0-20. Subscales are summed, with a total score from 0-144 and higher values represent a better outcome (more Quality of Life perceived).

Time frame: baseline, 4 months, 7 months

Emotional status

Patient's emotional state will be evaluated by Hospital Anxiety and Depression Scale (HAD), which assess the level of anxiety and depression. Subscales and score range are Anxiety (0-21) and Depression (0-21). Scoring: items of each subscale are summed, indicating: 0-7 normality, 8-10 probably case, 11-21 anxiety or depression clinical case. Higher values represent a worse outcome.

Time frame: baseline, 4 months, 7 months

Nociceptive pain

Nociceptive pain will be measured by the Visual Analog Scale for pain (VAS) from 0 to 10, where higher values represent a worse outcome.

Time frame: baseline, 4 months, 7 months

Neuropathic pain

Neuropathic pain evaluation by Pain Detect Questionnaire (Pain-Detect-Q-Spanish, with a total score 0-38, indicating: 0-12 absence of neuropathic pain; \>12-18 doubtful diagnosis and \>18-38 presence of neuropathic pain.

Data from ClinicalTrials.gov

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