Clinical trial NCT03529474: Psychology and Physiotherapy Approach of Chronic Pain in Patients With Hemophilia
Official title: Nonpharmacological Approach of Chronic Pain in Patients With Hemophilia: a Combined Approach From Psychology and Physiotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Haemophilia
Lead sponsor: Instituto de Investigacion Sanitaria La Fe
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2018-05-18
Enrollment: 19
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Changes in Perceived Self-efficacy: Chronic Pain Self-Efficacy Scale Spainsh Version. (Martín-Aragon et al., 1999).
timeFrame: baseline, 4 months, 7 months
Secondary outcomes:
measure: Quality of Life related with health
timeFrame: baseline, 4 months, 7 months
measure: Emotional status
timeFrame: baseline, 4 months, 7 months
measure: Nociceptive pain
timeFrame: baseline, 4 months, 7 months
measure: Neuropathic pain
timeFrame: baseline, 4 months, 7 months
measure: Kinesiophobia
timeFrame: baseline, 4 months, 7 months
measure: Functional capacity: The Timed "Up & Go" test
timeFrame: baseline, 4 months, 7 months
measure: Functional capacity: Sit-to-stand test
timeFrame: baseline, 4 months, 7 months
measure: Functional capacity: 2-minutes walk test
timeFrame: baseline, 4 months, 7 months
measure: Self-perceived functional capacity
timeFrame: baseline, 4 months, 7 months
measure: Active Range of Movement
timeFrame: baseline, 4 months, 7 months
measure: Joint health status
timeFrame: baseline, 4 months, 7 months
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Instituto de Investigación Sanitaria La Fe. Hospital Universitari i Politècnic La Fe
Study officials:
affiliation: Instituto de Investigación Sanitaria La Fe. Hospital Universitari i Politècnic La Fe
name: María García Dasí, Psych
role: PRINCIPAL_INVESTIGATOR
References: