Psychology and Physiotherapy Approach of Chronic Pain in Patients With Hemophilia

Instituto de Investigacion Sanitaria La Fe

Status: Completed

Conditions: Haemophilia

Treatments: Other: Psychology and Physiotherapy group; Other: Placebo comparator: control group

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03529474

2017/0320

Details and patient eligibility

About

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

Full 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

Enrollment: 19 patients

Sex: Male

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

19 participants in 2 patient groups, including a placebo group

Psychology and Physiotherapy group

Experimental group

Description:

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

Treatment:

Other: Psychology and Physiotherapy group

Placebo Comparator: Control group

Placebo Comparator group

Description:

Usual daily activities

Treatment:

Other: Placebo comparator: control group