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Trial record 1 of 1 for:    NCT03529474
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Psychology and Physiotherapy Approach of Chronic Pain in Patients With Hemophilia

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ClinicalTrials.gov Identifier: NCT03529474
Recruitment Status : Completed
First Posted : May 18, 2018
Last Update Posted : June 10, 2019
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Instituto de Investigacion Sanitaria La Fe

Tracking Information
First Submitted Date  ICMJE March 14, 2018
First Posted Date  ICMJE May 18, 2018
Last Update Posted Date June 10, 2019
Actual Study Start Date  ICMJE March 14, 2018
Actual Primary Completion Date March 15, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 7, 2018)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 6, 2019)
  • Quality of Life related with health [ Time Frame: baseline, 4 months, 7 months ]
    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 [ Time Frame: baseline, 4 months, 7 months ]
    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 [ Time Frame: baseline, 4 months, 7 months ]
    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 [ Time Frame: baseline, 4 months, 7 months ]
    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 [ Time Frame: baseline, 4 months, 7 months ]
    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 [ Time Frame: baseline, 4 months, 7 months ]
    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 [ Time Frame: baseline, 4 months, 7 months ]
    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 [ Time Frame: baseline, 4 months, 7 months ]
    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 [ Time Frame: baseline, 4 months, 7 months ]
    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 [ Time Frame: baseline, 4 months, 7 months ]
    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 [ Time Frame: baseline, 4 months, 7 months ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 7, 2018)
  • Quality of Life [ Time Frame: baseline, 4 months, 7 months ]
    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 [ Time Frame: baseline, 4 months, 7 months ]
    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 [ Time Frame: baseline, 4 months, 7 months ]
    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 [ Time Frame: baseline, 4 months, 7 months ]
    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 [ Time Frame: baseline, 4 months, 7 months ]
    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 [ Time Frame: baseline, 4 months, 7 months ]
    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 [ Time Frame: baseline, 4 months, 7 months ]
    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 [ Time Frame: baseline, 4 months, 7 months ]
    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 [ Time Frame: baseline, 4 months, 7 months ]
    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 [ Time Frame: baseline, 4 months, 7 months ]
    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 [ Time Frame: baseline, 4 months, 7 months ]
    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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Psychology and Physiotherapy Approach of Chronic Pain in Patients With Hemophilia
Official Title  ICMJE Nonpharmacological Approach of Chronic Pain in Patients With Hemophilia: a Combined Approach From Psychology and Physiotherapy
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Haemophilia
Intervention  ICMJE
  • Other: Psychology and Physiotherapy group

    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
  • Other: Placebo comparator: control group
    Control group Normal daily activities Usual daily activities
Study Arms  ICMJE
  • Experimental: 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: Other: Psychology and Physiotherapy group
  • Placebo Comparator: Placebo Comparator: Control group
    Usual daily activities
    Intervention: Other: Placebo comparator: control group
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 6, 2019)
19
Original Estimated Enrollment  ICMJE
 (submitted: May 7, 2018)
20
Actual Study Completion Date  ICMJE March 15, 2019
Actual Primary Completion Date March 15, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03529474
Other Study ID Numbers  ICMJE 2017/0320
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Instituto de Investigacion Sanitaria La Fe
Study Sponsor  ICMJE Instituto de Investigacion Sanitaria La Fe
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator: María García Dasí, Psych Instituto de Investigación Sanitaria La Fe. Hospital Universitari i Politècnic La Fe
PRS Account Instituto de Investigacion Sanitaria La Fe
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP