Psychology and Physiotherapy Approach of Chronic Pain in Patients With Hemophilia

NCT ID: NCT03529474

Last Updated: 2019-06-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-14
• Study Completion Date: 2019-03-15

Brief Summary

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

Detailed Description

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

Conditions

Haemophilia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Psychology and Physiotherapy group

The psychological program consists of 4 sessions (2 hours each) comprising psychoeducation, training techniques of psychological management of pain and kinesiophobia resources The physiotherapy program consists of 3 domiciliary sessions per week, including physical exercise and stretching

Group Type: EXPERIMENTAL

Psychology and Physiotherapy group

Intervention Type: OTHER

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 group

Usual daily activities

Group Type: PLACEBO_COMPARATOR

Placebo comparator: control group

Intervention Type: OTHER

Control group Normal daily activities Usual daily activities

Interventions

Psychology and Physiotherapy group

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

Intervention Type: OTHER

Placebo comparator: control group

Control group Normal daily activities Usual daily activities

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: collaborator

Instituto de Investigacion Sanitaria La Fe

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

María García Dasí, Psych

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Valencia, , Spain

Countries

Spain

Other Identifiers

2017/0320

Identifier Type: -

Identifier Source: org_study_id