Predicting Pain and Disability From Voice Recordings in Low Back Pain

NCT ID: NCT07078019

Last Updated: 2025-09-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 110 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-09-28
• Study Completion Date: 2025-09-30

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.

Detailed Description

Chronic low back pain (CLBP) is one of the most common musculoskeletal complaints and a leading cause of disability worldwide. Assessing pain severity and its impact on function is primarily reliant on self-reported tools such as the Visual Analog Scale (VAS) and functional indices like the Oswestry Disability Index (ODI) or Roland-Morris Disability Questionnaire (RMDQ). However, these tools may be influenced by subjectivity and reporting bias. Therefore, objective and non-invasive methods for pain assessment are needed.

This pilot observational study aims to investigate whether acoustic characteristics of voice recordings can be used to estimate pain intensity and functional impairment in individuals with CLBP. The hypothesis is that pain-induced changes in a patient's psychophysiological state may alter specific voice parameters (e.g., pitch, speech rate, pauses, intonation), which can be quantified through acoustic analysis.

After obtaining ethical approval, data will be collected at the Department of Physical Medicine and Rehabilitation. A total of 110 participants aged 18-70 years with chronic low back pain will be recruited. Each participant will be asked to read a standardized one-minute text aloud, and their voice will be recorded in a controlled setting. On the same day, participants will complete the VAS and either the ODI or RMDQ questionnaires.

Voice recordings will be analyzed using speech signal processing tools to extract features such as fundamental frequency, speech rate, articulation rate, pauses, and prosodic variations. These voice parameters will then be statistically correlated with VAS and disability scores.

Participants will be grouped by their VAS score (0-10), with an equal number of participants targeted for each pain level to ensure balanced data distribution. Written and verbal informed consent will be obtained from all participants. All recordings and data will be anonymized, and participants will retain the right to withdraw from the study at any time without consequence.

This study adheres to the principles of the Declaration of Helsinki and aims to provide early evidence supporting the feasibility of voice-based pain assessment. If successful, this approach could pave the way for low-cost, scalable, and objective tools to assist in the diagnosis and monitoring of chronic pain conditions.

Conditions

Chronic Low Back Pain (CLBP)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

VAS 0 Group

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

Voice Recording Procedure

Intervention Type: OTHER

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 1 Group

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

Voice Recording Procedure

Intervention Type: OTHER

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 2 Group

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

Voice Recording Procedure

Intervention Type: OTHER

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 3 Group

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

Voice Recording Procedure

Intervention Type: OTHER

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 4 Group

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

Voice Recording Procedure

Intervention Type: OTHER

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 5 Group

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

Voice Recording Procedure

Intervention Type: OTHER

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 6 Group

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

Voice Recording Procedure

Intervention Type: OTHER

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 7 Group

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

Voice Recording Procedure

Intervention Type: OTHER

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 8 Group

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

Voice Recording Procedure

Intervention Type: OTHER

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 9 Group

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

Voice Recording Procedure

Intervention Type: OTHER

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 10 Group

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

Voice Recording Procedure

Intervention Type: OTHER

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.

Interventions

Voice Recording Procedure

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

• Age below 18
• Illiterate individuals

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Erzurum Regional Training & Research Hospital

OTHER_GOV

Sponsor Role: collaborator

nurmuhammet tas

OTHER_GOV

Sponsor Role: lead

Responsible Party

nurmuhammet tas

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Central Contacts

nurmuhammet tas

Role: CONTACT

nu_mu_ta@hotmail.com

+905323380237

Other Identifiers

erzurum rtrh4

Identifier Type: -

Identifier Source: org_study_id