Clinical trial NCT04960475: Study of Negative Emotion, Fear-Avoidance Belief and Quality of Life in Patients With Ankle Sprain
Official title: An Observational Study of the Relationship Between Negative Emotion, Fear-Avoidance Belief and Quality of Life in Patients With Chronic Ankle Sprain
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Ankle Sprain
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2021-07-13
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Ankle sprains are the most common injury in everyday life, military training and sports. Forty percent of people with ankle sprains develop chronic ankle instability, including mechanical ankle instability and functional ankle instability. Mechanical ankle instability is usually caused by structural changes in the ligamentous tissue around the ankle, kinematic damage, synovial changes or degenerative joint disease. Functional ankle instability refers to the subjective perception of instability during daily life or sports. Most patients do not require surgery, and clinical examination reveals only minor swelling and localized pressure pain, but rarely severe structural damage to the joint with limited range of motion and joint instability. However, many patients with chronic functional instability of the ankle joint due to ankle sprain are unable to resume normal work and life due to emotional anxiety and repeatedly seek medical attention.

Brief summary: This study intends to investigate the negative emotions, fear-avoidance beliefs, and quality of life in patients with chronic ankle sprains to explore the relationship between negative emotions such as anxiety and depression, fear-avoidance beliefs, and their impact on quality of life.

Detailed description: Research design: This study is an observational study. It is planned to recruit a total of 120 patients with ankle sprain injury who meet the selection criteria from the Rehabilitation Department of Peking University Third Hospital. They will be divided into an anxiety and depression group and a control group based on anxiety and depression scale. Basic information, anxiety and depression scales, fear-avoidance beliefs score and quality of life score of two groups will be compared and analyzed.

Eligibility criteria: Inclusion Criteria:

* Ankle sports injury time\> 6 months;
* age 18-50 years;
* no pain in daily activities, or a numerical rating scale (NRS) 6 points or less;
* no mechanical instability of the ankle joint and obvious restriction in joint movement ;
* agree to participate in this study.

Exclusion Criteria:

* acute inflammation of lower limb joints;
* new or unhealed lower limb fractures;
* history of lower limb surgery within 3 months;
* lower limb pain caused by other diseases (such as lumbar disease, vascular disease, etc.);
* speech and cognitive impairment
* other diseases that cannot participate in this study.

Primary outcomes:
measure: FABQ score
timeFrame: 1 hr
measure: SF-36 score
timeFrame: 1 hr
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
Study officials:
affiliation: Peking University Third Hospital
name: Hongying Zhong
role: PRINCIPAL_INVESTIGATOR
References: