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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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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
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Placebo Comparator: Control group | Placebo Comparator | Usual daily activities |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Psychology and Physiotherapy group | Other | Psychological program: 4 sessions,2 hours each,4 months
Physiotherapy program:3 sessions per week,1 hour per session,4 months:
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life related with health | Measured by a Specific questionnaire for Quality of Life related with health evaluation for adults with haemophilia (A36Haemophilia-QoL), which explores 9 areas. Subscales and score range: Physical health: 0-32; Daily activities: 0-16; Joints: 0-12; Pain: 0-8; Treatment satisfaction: 0-8; Difficulties treatment: 0-16; Emotional functioning: 0-20; Mental health: 0-12; Social activity: 0-20. Subscales are summed, with a total score from 0-144 and higher values represent a better outcome (more Quality of Life perceived). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| María García Dasí, Psych | Instituto de Investigación Sanitaria La Fe. Hospital Universitari i Politècnic La Fe | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto de Investigación Sanitaria La Fe. Hospital Universitari i Politècnic La Fe | Valencia | 46026 | Spain |
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| ID | Term |
|---|---|
| D006467 | Hemophilia A |
| ID | Term |
|---|---|
| D025861 | Blood Coagulation Disorders, Inherited |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D011584 | Psychology |
| D026741 | Physical Therapy Modalities |
| ID | Term |
|---|---|
| D001525 | Behavioral Sciences |
| D004191 | Behavioral Disciplines and Activities |
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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| Placebo comparator: control group | Other | Control group Normal daily activities Usual daily activities |
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| baseline, 4 months, 7 months |
| Emotional status | Patient's emotional state will be evaluated by Hospital Anxiety and Depression Scale (HAD), which assess the level of anxiety and depression. Subscales and score range are Anxiety (0-21) and Depression (0-21). Scoring: items of each subscale are summed, indicating: 0-7 normality, 8-10 probably case, 11-21 anxiety or depression clinical case. Higher values represent a worse outcome. | baseline, 4 months, 7 months |
| Nociceptive pain | Nociceptive pain will be measured by the Visual Analog Scale for pain (VAS) from 0 to 10, where higher values represent a worse outcome. | baseline, 4 months, 7 months |
| Neuropathic pain | Neuropathic pain evaluation by Pain Detect Questionnaire (Pain-Detect-Q-Spanish, with a total score 0-38, indicating: 0-12 absence of neuropathic pain; >12-18 doubtful diagnosis and >18-38 presence of neuropathic pain. | baseline, 4 months, 7 months |
| Kinesiophobia | Kinesiophobia will be evaluated by Tampa Scale for Kinesiophobia (TSK-11SV) (Spanish adaptation. Gómez-Pérez, López-Martínez y Ruiz-Párraga, 2011). Scoring: Items are summed, with a total score from 11-44 and higher values represent a worse outcome (more pain interference in behavior). | baseline, 4 months, 7 months |
| Functional capacity: The Timed "Up & Go" test | Timed "Up & Go" will be used to measure functional capacity. Less time to complete the test in seconds implies better outcome | baseline, 4 months, 7 months |
| Functional capacity: Sit-to-stand test | Sit-to-stand test will be used to measure functional capacity. Less time to complete the test in seconds implies better outcome | baseline, 4 months, 7 months |
| Functional capacity: 2-minutes walk test | Evaluation of functional capacity during walking by using 2 minutes walk test. More distance covered in 2 minutes implies better outcome. | baseline, 4 months, 7 months |
| Self-perceived functional capacity | Impact of haemophilia on self-perceived functional abilities in adults measured by Haemophilia Activities List questionnaire (HAL). It contains 42 multiple choice questions in seven domains (Sum Score: 42-252). Normalized scores for the domains and the full questionnaire can also be obtained, being possible scores range from 0 to 100, where 0 represents the worst possible functional status and 100 the best possible functional status. | baseline, 4 months, 7 months |
| Active Range of Movement | A digital goniometer will be used (Digital absolute Axis goniometer, Baseline evaluation instruments, White Plains, USA) for the measurement of active elbow, knee and ankle range of movement. | baseline, 4 months, 7 months |
| Joint health status | Joint clinical evaluation of elbows, knees and ankles by using The Hemophilia Joint Health Score 2.1 (HJHS). The full score range goes from 0 to 124 points (0-20 points for each of the six joints evaluated, plus 4 points for the overall assessment of gait. 0 means no joint damage, whereas the higher the value, the higher the degree of arthropathy. | baseline, 4 months, 7 months |
| D020147 | Coagulation Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |