Effect of Cognitive Behavioral Therapy on Kinesiophobia and Functional Outcomes After Total Hip Arthroplasty.

Официальное название

Effect of Cognitive Behavioral Therapy on Kinesiophobia and Clinical Outcomes After Total Hip Arthroplasty: A Randomized Controlled Trial.

Обзор

The goal of this clinical trial study is to evaluate the effectiveness of cognitive behavioral therapy in reducing kinesiophobia and improving Clinical outcomes in postoperative patients following total hip arthroplasty The main question it aims to answer is: Does the addition of cognitive behavioral therapy to standard physical therapy rehabilitation exercise reduce kinesiophobia and pain while improving functional mobility and quality of life in postoperative patients after total hip arthroplasty ? Participants will be divided into two groups to be compared: the first group (Control group) will only receive standard physical therapy rehabilitation exercises , consistent with routine post-total hip arthroplasty care, while the second group ( experimental group) will receive the same program in addition to cognitive behavioral therapy.

Подробное описание

Cognitive behavioral therapy is a psychological therapy that helps individuals modify unhelpful thoughts and behaviors to improve emotions and functioning (American Psychological Association , 2017). Emerging studies have shown that cognitive behavioral therapy is effective in reducing kinesiophobia in postoperative patients after joint athroplasty , with recent evidence specifically in total knee arthroplasty (Sun Et al.,2020).

Thus ,the investigators hypothesize that adding cognitive behavioral therapy (CBT) to a standard physical therapy rehabilitation program will improve kinesiophobia and clinical outcomes after total hip arthroplasty.

Вмешательства

• Поведенческое Cognitive-behavioral therapy
  Four Cognitive Behavioral Therapy sessions will be delivered over a 12-week period.
• Другое Exercise
  The Standard rehabilitation program consisting of active exercises will be delivered over a 12-week period

Первичные конечные точки

• Tampa Scale of kinesiophobia (TSK) [Срок оценки: Day 1 , 6 weeks , 12 weeks, 6 months as follow up.]

Вторичные конечные точки (3)

• Numerical Pain Rating Scale Score (NPRS) [Срок оценки: day 1 , 6 weeks , 12 weeks, 6 months as follow up]
• Harris Hip Score (HHS) [Срок оценки: day 1 , 6weeks , 12 weeks , 6 months as follow up]
• Assessmeny of qulity of life by SF-36 Form [Срок оценки: day 1, 6weeks , 12 weeks and 6 months as follow up.]

Критерии участия

Критерии включения

((1) postoperative unilateral THA for the first time; (2) at least primary education; (3) ≥18 years of age ; (4) voluntary participation and close cooperation with the care plan; and (5) agreement to continue the intervention and the six-month follow-up after discharge,(6) high level of kinesiophobia on Tampa Scale of Kinesiophobia(TSK), (7)medically stable and cleared by their orthopedic surgeon.

Критерии исключения

(1) revision surgery, (2) severe osteoarthritis in the contralateral hip, (3) severe acute metabolic neuromuscular and cardiovascular disease, (4) body mass index above 40, (5) presence of malignancy, any other orthopedic or neurologic problem that might affect treatment and assessments, (6) any condition that might interfere with communication, (7) or lack of cooperation during the study.(9) Individuals with cognitive disorder,(10) individuals with any psychological disease or disorder,(10) Had previously participated in a CBT intervention,(11) pregnancy.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• Cairo University Hospitals — Giza

Публикации

• Kumar P, Sen R, Aggarwal S, Agarwal S, Rajnish RK. Reliability of Modified Harris Hip Score as a tool for outcome evaluation of Total Hip Replacements in Indian population. J Clin Orthop Trauma. 2019 Jan-Feb;10(1):128-130. doi: 10.1016/j.jcot.2017.11.019. Epub 2017 Dec 6. PMID 30705547
• Dupuis F, Cherif A, Batcho C, Masse-Alarie H, Roy JS. The Tampa Scale of Kinesiophobia: A Systematic Review of Its Psychometric Properties in People With Musculoskeletal Pain. Clin J Pain. 2023 May 1;39(5):236-247. doi: 10.1097/AJP.0000000000001104. PMID 36917768
• Brazier JE, Harper R, Jones NM, O'Cathain A, Thomas KJ, Usherwood T, Westlake L. Validating the SF-36 health survey questionnaire: new outcome measure for primary care. BMJ. 1992 Jul 18;305(6846):160-4. doi: 10.1136/bmj.305.6846.160. PMID 1285753
• Monaghan B, Grant T, Hing W, Cusack T. Functional exercise after total hip replacement (FEATHER): a randomised control trial. BMC Musculoskelet Disord. 2012 Nov 28;13:237. doi: 10.1186/1471-2474-13-237. PMID 23190932
• Al-Amiry B, Rahim A, Knutsson B, Mattisson L, Sayed-Noor A. Kinesiophobia and its association with functional outcome and quality of life 6-8 years after total hip arthroplasty. Acta Orthop Traumatol Turc. 2022 Jul;56(4):252-255. doi: 10.5152/j.aott.2022.21318. PMID 35968616
• Marmouta P, Marmouta L, Tsounis A, Tzavara C, Malliarou M, Fradelos E, Saridi M, Toska A, Sarafis P. Effect of Kinesiophobia and Social Support on Quality of Life After Total Hip Arthoplasty. Healthcare (Basel). 2025 Jun 6;13(12):1366. doi: 10.3390/healthcare13121366. PMID 40565392

Идентификаторы

NCT: NCT07427758 · Cognitive Behavioral Therapy

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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