Back to resultsPsychology and Physiotherapy Approach of Chronic Pain in Patients With Hemophilia
Primary Purpose
Haemophilia
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Psychology and Physiotherapy group
Placebo comparator: control group
Sponsored by
About this trial
This is an interventional treatment trial for Haemophilia
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
Sites / Locations
- Instituto de Investigación Sanitaria La Fe. Hospital Universitari i Politècnic La Fe
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Psychology and Physiotherapy group
Placebo Comparator: Control group
Arm 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
Usual daily activities
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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).
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.
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.
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.
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).
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
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
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.
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.
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.
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.
Full Information
NCT ID
NCT03529474
First Posted
March 14, 2018
Last Updated
June 6, 2019
Sponsor
Instituto de Investigacion Sanitaria La Fe
Collaborators
Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT03529474
Brief Title
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
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
March 14, 2018 (Actual)
Primary Completion Date
March 15, 2019 (Actual)
Study Completion Date
March 15, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto de Investigacion Sanitaria La Fe
Collaborators
Pfizer
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Haemophilia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Psychology and Physiotherapy group
Arm Type
Experimental
Arm 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
Arm Title
Placebo Comparator: Control group
Arm Type
Placebo Comparator
Arm Description
Usual daily activities
Intervention Type
Other
Intervention Name(s)
Psychology and Physiotherapy group
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Placebo comparator: control group
Intervention Description
Control group Normal daily activities Usual daily activities
Primary Outcome Measure Information:
Title
Changes in Perceived Self-efficacy: Chronic Pain Self-Efficacy Scale Spainsh Version. (Martín-Aragon et al., 1999).
Description
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).
Time Frame
baseline, 4 months, 7 months
Secondary Outcome Measure Information:
Title
Quality of Life related with health
Description
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).
Time Frame
baseline, 4 months, 7 months
Title
Emotional status
Description
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.
Time Frame
baseline, 4 months, 7 months
Title
Nociceptive pain
Description
Nociceptive pain will be measured by the Visual Analog Scale for pain (VAS) from 0 to 10, where higher values represent a worse outcome.
Time Frame
baseline, 4 months, 7 months
Title
Neuropathic pain
Description
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.
Time Frame
baseline, 4 months, 7 months
Title
Kinesiophobia
Description
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).
Time Frame
baseline, 4 months, 7 months
Title
Functional capacity: The Timed "Up & Go" test
Description
Timed "Up & Go" will be used to measure functional capacity. Less time to complete the test in seconds implies better outcome
Time Frame
baseline, 4 months, 7 months
Title
Functional capacity: Sit-to-stand test
Description
Sit-to-stand test will be used to measure functional capacity. Less time to complete the test in seconds implies better outcome
Time Frame
baseline, 4 months, 7 months
Title
Functional capacity: 2-minutes walk test
Description
Evaluation of functional capacity during walking by using 2 minutes walk test. More distance covered in 2 minutes implies better outcome.
Time Frame
baseline, 4 months, 7 months
Title
Self-perceived functional capacity
Description
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.
Time Frame
baseline, 4 months, 7 months
Title
Active Range of Movement
Description
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.
Time Frame
baseline, 4 months, 7 months
Title
Joint health status
Description
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.
Time Frame
baseline, 4 months, 7 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
María García Dasí, Psych
Organizational Affiliation
Instituto de Investigación Sanitaria La Fe. Hospital Universitari i Politècnic La Fe
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto de Investigación Sanitaria La Fe. Hospital Universitari i Politècnic La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Psychology and Physiotherapy Approach of Chronic Pain in Patients With Hemophilia
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