NCT07078019

Brief Summary

This study aims to investigate whether pain intensity (assessed by Visual Analog Scale - VAS) and functional impairment (Roland-Morris Disability Questionnaire \[RMDQ\] or Oswestry Disability Index \[ODI\]) in patients with chronic low back pain can be estimated using acoustic features extracted from short voice recordings.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
110

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2025

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

July 12, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 22, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

September 28, 2025

Completed
2 days 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

September 19, 2025

Status Verified

September 1, 2025

Enrollment Period

2 days

First QC Date

July 12, 2025

Last Update Submit

September 18, 2025

Conditions

Chronic Low Back Pain (CLBP)

Keywords

Chronic low back painVoice analysisOswestry Disability IndexRoland-Morris QuestionnaireAcoustic biomarkersPain assessmentVAS

Outcome Measures

Primary Outcomes (1)

  • Correlation between voice features and pain level (VAS score)

    Voice parameters such as pitch, tone, speech rate, and pauses will be analyzed and statistically correlated with pain levels as measured by the Visual Analog Scale (VAS). The VAS is a self-reported pain measurement tool scored on a scale from 0 to 10, where: 0 indicates no pain, and 10 indicates the worst pain imaginable. Higher scores represent worse pain outcomes.

    At the time of enrollment

Secondary Outcomes (1)

  • Correlation between voice features and functional impairment (Oswestry Disability Index [ODI] or Roland-Morris Disability Questionnaire [RMDQ])

    At the time of enrollment

Study Arms (11)

VAS 0 Group

Participants with chronic low back pain reporting a VAS score of 0

Other: Voice Recording Procedure

VAS 1 Group

Participants with chronic low back pain reporting a VAS score of 1

Other: Voice Recording Procedure

VAS 2 Group

Participants with chronic low back pain reporting a VAS score of 2

Other: Voice Recording Procedure

VAS 3 Group

Participants with chronic low back pain reporting a VAS score of 3

Other: Voice Recording Procedure

VAS 4 Group

Participants with chronic low back pain reporting a VAS score of 4

Other: Voice Recording Procedure

VAS 5 Group

Participants with chronic low back pain reporting a VAS score of 5

Other: Voice Recording Procedure

VAS 6 Group

Participants with chronic low back pain reporting a VAS score of 6

Other: Voice Recording Procedure

VAS 7 Group

Participants with chronic low back pain reporting a VAS score of 7

Other: Voice Recording Procedure

VAS 8 Group

Participants with chronic low back pain reporting a VAS score of 8

Other: Voice Recording Procedure

VAS 9 Group

Participants with chronic low back pain reporting a VAS score of 9

Other: Voice Recording Procedure

VAS 10 Group

Participants with chronic low back pain reporting a VAS score of 10

Other: Voice Recording Procedure

Interventions

Voice Recording ProcedureOTHER

Participants will be asked to read a standardized one-minute text aloud in a quiet room. Their voices will be recorded using a high-quality microphone. The recordings will later be analyzed for acoustic features such as pitch, speech rate, pauses, and intonation. This procedure is non-invasive and does not involve any clinical or pharmacological intervention.

VAS 0 GroupVAS 1 GroupVAS 10 GroupVAS 2 GroupVAS 3 GroupVAS 4 GroupVAS 5 GroupVAS 6 GroupVAS 7 GroupVAS 8 GroupVAS 9 Group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adults aged 18 to 70 years with chronic low back pain who are literate and visiting the physical medicine and rehabilitation outpatient clinic. Participants must be able to read and speak Turkish fluently to complete questionnaires and perform the standardized reading task for voice recording. Individuals with acute back pain, neurological disorders, or communication impairments are excluded.

You may qualify if:

  • Age between 18-70 years
  • Diagnosed with chronic low back pain and attending the physical medicine and rehabilitation clinic
  • Literate (able to read and write)

You may not qualify if:

  • Age below 18
  • Illiterate individuals

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

nurmuhammet tas

CONTACT

+905323380237nu_mu_ta@hotmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 12, 2025

First Posted

July 22, 2025

Study Start

September 28, 2025

Primary Completion

September 30, 2025

Study Completion

September 30, 2025

Last Updated

September 19, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Anonymized data may be used in aggregated form for publication.