Psychology and Physiotherapy Approach of Chronic Pain in Patients With Hemophilia

NCT03529474 | Completed

• 1 other identifier: 2017/0320
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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

Conditions

Haemophilia

Outcome Measures

Primary Outcomes (1)

• 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).

  baseline, 4 months, 7 months

Secondary Outcomes (11)

• Quality of Life related with health

  baseline, 4 months, 7 months

• Emotional status

  baseline, 4 months, 7 months

• Nociceptive pain

  baseline, 4 months, 7 months

• Neuropathic pain

  baseline, 4 months, 7 months

• Kinesiophobia

  baseline, 4 months, 7 months

Study Arms (2)

Psychology and Physiotherapy group

EXPERIMENTAL

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

Other: Psychology and Physiotherapy group

Placebo Comparator: Control group

PLACEBO COMPARATOR

Usual daily activities

Other: Placebo comparator: control group

Interventions

Psychology and Physiotherapy group 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

Psychology and Physiotherapy group

Placebo comparator: control group OTHER

Control group Normal daily activities Usual daily activities

Placebo Comparator: Control group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto de Investigacion Sanitaria La Fe: lead
• Pfizer: collaborator

Study Sites (1)

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

Valencia, 46026, Spain

Location

MeSH Terms

Conditions

Hemophilia A

Interventions

Psychology; Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Behavioral Sciences; Behavioral Disciplines and Activities; Therapeutics; Rehabilitation

Study Officials

• María García Dasí, Psych

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2018
• First Posted: May 18, 2018
• Study Start: March 14, 2018
• Primary Completion: March 15, 2019
• Study Completion: March 15, 2019
• Last Updated: June 10, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)