Nonpharmacological Approach of Chronic Pain in Patients With Hemophilia: a Combined Approach From Psychology and Physiotherapy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 19
- Locations
- 2
- Primary Endpoint
- Changes in Perceived Self-efficacy: Chronic Pain Self-Efficacy Scale Spainsh Version. (Martín-Aragon et al., 1999).
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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
Intervention: Psychology and Physiotherapy group (Other)
Placebo Comparator: Control group
Usual daily activities
Intervention: Placebo comparator: control group (Other)
Outcomes
Primary Outcomes
Changes in Perceived Self-efficacy: Chronic Pain Self-Efficacy Scale Spainsh Version. (Martín-Aragon et al., 1999).
Time Frame: baseline, 4 months, 7 months
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).
Secondary Outcomes
- Functional capacity: The Timed "Up & Go" test(baseline, 4 months, 7 months)
- Quality of Life related with health(baseline, 4 months, 7 months)
- Nociceptive pain(baseline, 4 months, 7 months)
- Emotional status(baseline, 4 months, 7 months)
- Neuropathic pain(baseline, 4 months, 7 months)
- Kinesiophobia(baseline, 4 months, 7 months)
- Functional capacity: 2-minutes walk test(baseline, 4 months, 7 months)
- Functional capacity: Sit-to-stand test(baseline, 4 months, 7 months)
- Self-perceived functional capacity(baseline, 4 months, 7 months)
- Active Range of Movement(baseline, 4 months, 7 months)
- Joint health status(baseline, 4 months, 7 months)