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

• Conditions: Chronic Ankle Sprain
• Interventions: Other: Hospital Anxious and Depression(HADS); Other: Fear-Avoidance Belief Questionnaire (FABQ); Other: The MOS 36-Item Short From Health Survey (SF-36)

• Registration Number: NCT04960475
• Lead Sponsor: Peking University Third Hospital

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.

Study Timeline

• Study Start: 2021-01-01
• Status Verified: 2021-07
• Study First Submitted: 2021-07-04
• Study First Submitted QC: 2021-07-04
• Study First Posted: 2021-07-13
• Last Update Submitted: 2021-11-23
• Last Update Posted: 2021-11-24
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 140

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control group	Hospital Anxious and Depression(HADS)	Chronic ankle sprain patient with no emotional issues
A/D group	The MOS 36-Item Short From Health Survey (SF-36)	Chronic ankle sprain patient with anxity or depression
A/D group	Fear-Avoidance Belief Questionnaire (FABQ)	Chronic ankle sprain patient with anxity or depression
Control group	Fear-Avoidance Belief Questionnaire (FABQ)	Chronic ankle sprain patient with no emotional issues
A/D group	Hospital Anxious and Depression(HADS)	Chronic ankle sprain patient with anxity or depression
Control group	The MOS 36-Item Short From Health Survey (SF-36)	Chronic ankle sprain patient with no emotional issues

Primary Outcome Measures

Name	Time	Method
FABQ score	1 hr	the total score of Fear-Avoidance Belief Questionnaire
SF-36 score	1 hr	the score of SF36 questionnaire

Trial Locations

Locations (1)

Peking University Third Hospital; 🇨🇳 Beijing, China