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Recruiting NCT07427758

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

No phase Interventional Total Hip Arthroplasty (THA) Kinesiophobia (Fear of Movement)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cognitive-behavioral therapy, Exercise.
Who it may be relevant to
Registry conditions: Total Hip Arthroplasty (THA), Kinesiophobia (Fear of Movement). Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Detailed description

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.

Interventions

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

Primary outcome measures

  • Tampa Scale of kinesiophobia (TSK) [Time frame: Day 1 , 6 weeks , 12 weeks, 6 months as follow up.]
Secondary outcome measures (3)
  • Numerical Pain Rating Scale Score (NPRS) [Time frame: day 1 , 6 weeks , 12 weeks, 6 months as follow up]
  • Harris Hip Score (HHS) [Time frame: day 1 , 6weeks , 12 weeks , 6 months as follow up]
  • Assessmeny of qulity of life by SF-36 Form [Time frame: day 1, 6weeks , 12 weeks and 6 months as follow up.]

Eligibility criteria

Inclusion criteria

((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.

Exclusion criteria

(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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Cairo University Hospitals — Giza

Publications

  • 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

Identifiers

NCT: NCT07427758 · Cognitive Behavioral Therapy

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗