Low Back PainNCT06684665
Study on the Sociopsychoemotional Mechanism of Dysfunction in Patients With Acute and Chronic Low Back Pain
An observational study of Low Back Pain, run by Second Affiliated Hospital of Wenzhou Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 27 Nov 2023to 30 Sep 2025
- How long will I take part?
- 2 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population consisted of patients who met the requirements of outpatient complaints and healthy people in daily life
Who may be able to join
- Age 18-75;
- Patients with low back pain;
- Have good communication skills to ensure the collection of scale information
Who cannot join
- Suffering from severe mental or psychiatric disorders.;
- Unwilling to participate in the interview;
- Patients with pain in other areas
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000
About this study
Official title: 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.
- Conditions
- Low Back Pain
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to 2 months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start27 Nov 2023
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital of Wenzhou Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 2 Months
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06684665
- Sponsor's protocol ID
- SAHoWMU-CR2024-13-219
- Status last verified
- May 2025
- First submitted
- 10 Nov 2024
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Introduction;Epidemiology;Socioeconomic Burden
- ClinicalTrials.gov ID
- NCT06684665
- Acronym / sponsor ID
- SAHoWMU-CR2024-13-219
- Conditions
- Low Back Pain
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 27 Nov 2023 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 12 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Other
- Target follow-up
- 2 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consisted of patients who met the requirements of outpatient complaints and healthy people in daily life
Key inclusion criteria (3 listed)
- Age 18-75;
- Patients with low back pain;
- Have good communication skills to ensure the collection of scale information
Key exclusion criteria (3 listed)
- Suffering from severe mental or psychiatric disorders.;
- Unwilling to participate in the interview;
- Patients with pain in other areas
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Dysfunction index of patients with acute and chronic low back pain
Time frame: From enrollment to 2 months later
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Back Pain, run by Second Affiliated Hospital of Wenzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dysfunction index of patients with acute and chronic low back pain (time frame: From enrollment to 2 months later). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2025.