Psychology and Physiotherapy Approach of Chronic Pain in Patients With Hemophilia
2019年6月6日 更新者：Instituto de Investigacion Sanitaria La Fe
Nonpharmacological Approach of Chronic Pain in Patients With Hemophilia: a Combined Approach From Psychology and Physiotherapy
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
調査の概要
詳細な説明
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
研究の種類
介入
入学 (実際)
19
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Valencia、スペイン、46026
- Instituto de Investigación Sanitaria La Fe. Hospital Universitari i Politècnic La Fe
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～60年 (大人)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
男
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：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
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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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プラセボコンパレーター：Placebo Comparator: Control group
Usual daily activities
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Control group Normal daily activities Usual daily activities
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Changes in Perceived Self-efficacy: Chronic Pain Self-Efficacy Scale Spainsh Version. (Martín-Aragon et al., 1999).
時間枠：baseline, 4 months, 7 months
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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).
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baseline, 4 months, 7 months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Quality of Life related with health
時間枠：baseline, 4 months, 7 months
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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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baseline, 4 months, 7 months
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Emotional status
時間枠：baseline, 4 months, 7 months
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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.
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baseline, 4 months, 7 months
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Nociceptive pain
時間枠：baseline, 4 months, 7 months
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Nociceptive pain will be measured by the Visual Analog Scale for pain (VAS) from 0 to 10, where higher values represent a worse outcome.
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baseline, 4 months, 7 months
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Neuropathic pain
時間枠：baseline, 4 months, 7 months
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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.
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baseline, 4 months, 7 months
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Kinesiophobia
時間枠：baseline, 4 months, 7 months
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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).
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baseline, 4 months, 7 months
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Functional capacity: The Timed "Up & Go" test
時間枠：baseline, 4 months, 7 months
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Timed "Up & Go" will be used to measure functional capacity.
Less time to complete the test in seconds implies better outcome
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baseline, 4 months, 7 months
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Functional capacity: Sit-to-stand test
時間枠：baseline, 4 months, 7 months
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Sit-to-stand test will be used to measure functional capacity.
Less time to complete the test in seconds implies better outcome
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baseline, 4 months, 7 months
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Functional capacity: 2-minutes walk test
時間枠：baseline, 4 months, 7 months
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Evaluation of functional capacity during walking by using 2 minutes walk test.
More distance covered in 2 minutes implies better outcome.
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baseline, 4 months, 7 months
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Self-perceived functional capacity
時間枠：baseline, 4 months, 7 months
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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.
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baseline, 4 months, 7 months
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Active Range of Movement
時間枠：baseline, 4 months, 7 months
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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.
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baseline, 4 months, 7 months
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Joint health status
時間枠：baseline, 4 months, 7 months
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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.
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baseline, 4 months, 7 months
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
協力者
捜査官
- 主任研究者：María García Dasí, Psych、Instituto de Investigación Sanitaria La Fe. Hospital Universitari i Politècnic La Fe
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2018年3月14日
一次修了 (実際)
2019年3月15日
研究の完了 (実際)
2019年3月15日
試験登録日
最初に提出
2018年3月14日
QC基準を満たした最初の提出物
2018年5月7日
最初の投稿 (実際)
2018年5月18日
学習記録の更新
投稿された最後の更新 (実際)
2019年6月10日
QC基準を満たした最後の更新が送信されました
2019年6月6日
最終確認日
2019年6月1日
詳しくは
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