Study on the Sociopsychoemotional Mechanism of Dysfunction in Patients With Acute and Chronic Low Back Pain

Introduction;Epidemiology;Socioeconomic Burden

Low back pain is defined as pain that extends from the 12th rib to the iliac bone, and its increasing incidence makes it one of the major causes of decreased productivity worldwide. Dysfunction is one of the important complications in patients with chronic low back pain, and related studies have shown that depression, pain catastrophization and other emotions can affect the occurrence and development of dysfunction. So the investigators wanted to study which psychological emotions affect the development of dysfunction in patients with low back pain.

Study Overview

• Status: Enrolling by invitation
• Conditions: Low Back Pain

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Wenzhou, Zhejiang, China, 325000
      • The Second Affiliated Hospital of Wenzhou Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The study population consisted of patients who met the requirements of outpatient complaints and healthy people in daily life

Description

Inclusion Criteria:

1. Age 18-75;
2. Patients with low back pain;
3. Have good communication skills to ensure the collection of scale information

Exclusion Criteria:

1. Suffering from severe mental or psychiatric disorders.;
2. Unwilling to participate in the interview;
3. Patients with pain in other areas

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Healthy group; The healthy subjects were subjects without back pain
Acute low back pain group; The acute low back pain group was defined as those with low back pain that lasted less than three months
Chronic low back pain group; The chronic low back pain group was the subjects with low back pain, and the duration was greater than or equal to three months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dysfunction index of patients with acute and chronic low back pain	Dysfunction is one of the important complications in patients with chronic low back pain, and related studies have shown that depression, pain catastrophization and other emotions can affect the occurrence and development of dysfunction. The dysfunction index of patients with different course of disease was different from that of healthy people.	From enrollment to 2 months later

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital of Wenzhou Medical University

Study record dates

Study Major Dates

• Study Start (Actual): November 27, 2023
• Primary Completion (Estimated): September 30, 2025
• Study Completion (Estimated): September 30, 2025

Study Registration Dates

• First Submitted: November 10, 2024
• First Submitted That Met QC Criteria: November 10, 2024
• First Posted (Actual): November 12, 2024

Study Record Updates

• Last Update Posted (Actual): May 16, 2025
• Last Update Submitted That Met QC Criteria: May 13, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: SAHoWMU-CR2024-13-219

Drug and device information, study documents

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