Study of Negative Emotion, Fear-Avoidance Belief and Quality of Life in Patients With Ankle Sprain

An Observational Study of the Relationship Between Negative Emotion, Fear-Avoidance Belief and Quality of Life in Patients With Chronic Ankle Sprain

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Chronic Ankle Sprain
• Intervention / Treatment: Other: Hospital Anxious and Depression(HADS); Other: Fear-Avoidance Belief Questionnaire (FABQ); Other: The MOS 36-Item Short From Health Survey (SF-36)

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.

• Study Type: Observational
• Enrollment (Actual): 140

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Peking University Third Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
A/D group; Chronic ankle sprain patient with anxity or depression	Other: Hospital Anxious and Depression(HADS); The assessment content in the scale is divided into two parts: anxiety and depression. Anxiety is an unexplained state of restlessness, manifested as tension, fear, and panic all day long. Depression is manifested as depression, slow thinking, decreased volition and physical symptoms. The two parts are scored separately. A total score of 0-7 means normal, a total score of 8-10 means mild depression/anxiety, a total score of 11-14 means moderate depression/anxiety, and a total score of 15-21 means severe depression/ anxiety.; Other: Fear-Avoidance Belief Questionnaire (FABQ); FABQ is a self-assessment questionnaire with 16 options. Each option has 7 levels of 0-6 points, representing totally disagree, uncertain, and totally agree; there are 2 subscales, and one subscale measures the fear-avoidance in physical activity, another subscale measures fear-avoidance of work. The final score of FABQ is the superposition of the value of each item. A high score indicates a high level of fear-avoidance beliefs.; Other: The MOS 36-Item Short From Health Survey (SF-36); The SF-36 is a multi-purpose survey designed to capture adult patients' perceptions of their own health and well-being. The SF-36 has 36 items grouped in 8 dimensions: physical functoning, physicial and emotional limitations, social functioning, bodily pain, general and mental health.
Control group; Chronic ankle sprain patient with no emotional issues	Other: Hospital Anxious and Depression(HADS); The assessment content in the scale is divided into two parts: anxiety and depression. Anxiety is an unexplained state of restlessness, manifested as tension, fear, and panic all day long. Depression is manifested as depression, slow thinking, decreased volition and physical symptoms. The two parts are scored separately. A total score of 0-7 means normal, a total score of 8-10 means mild depression/anxiety, a total score of 11-14 means moderate depression/anxiety, and a total score of 15-21 means severe depression/ anxiety.; Other: Fear-Avoidance Belief Questionnaire (FABQ); FABQ is a self-assessment questionnaire with 16 options. Each option has 7 levels of 0-6 points, representing totally disagree, uncertain, and totally agree; there are 2 subscales, and one subscale measures the fear-avoidance in physical activity, another subscale measures fear-avoidance of work. The final score of FABQ is the superposition of the value of each item. A high score indicates a high level of fear-avoidance beliefs.; Other: The MOS 36-Item Short From Health Survey (SF-36); The SF-36 is a multi-purpose survey designed to capture adult patients' perceptions of their own health and well-being. The SF-36 has 36 items grouped in 8 dimensions: physical functoning, physicial and emotional limitations, social functioning, bodily pain, general and mental health.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
FABQ score	the total score of Fear-Avoidance Belief Questionnaire	1 hr
SF-36 score	the score of SF36 questionnaire	1 hr

Collaborators and Investigators

• Sponsor: Peking University Third Hospital
• Investigators: Principal Investigator: Hongying Zhong, Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: July 4, 2021
• First Submitted That Met QC Criteria: July 4, 2021
• First Posted (Actual): July 13, 2021

Study Record Updates

• Last Update Posted (Actual): November 24, 2021
• Last Update Submitted That Met QC Criteria: November 23, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Sprains and Strains; Ankle Injuries
• Other Study ID Numbers: M2021078

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No