NCT06684665

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 27, 2023

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

November 10, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 12, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
Last Updated

May 16, 2025

Status Verified

May 1, 2025

Enrollment Period

1.8 years

First QC Date

November 10, 2024

Last Update Submit

May 13, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

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

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Second Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Target Duration
2 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 10, 2024

First Posted

November 12, 2024

Study Start

November 27, 2023

Primary Completion

September 30, 2025

Study Completion

September 30, 2025

Last Updated

May 16, 2025

Record last verified: 2025-05

Locations