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NCT Number: NCT07078019

Predicting Pain and Disability From Voice Recordings in Low Back Pain

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Voice Recording Procedure

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.

Primary outcomes

  1. Correlation between voice features and pain level (VAS score)

    Time frame: At the time of enrollment

    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.

Secondary outcomes

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

    Time frame: At the time of enrollment

    Functional disability levels will be assessed using either the Oswestry Disability Index (ODI) or the Roland-Morris Disability Questionnaire (RMDQ) and will be correlated with acoustic voice features such as pitch, tone, speech rate, and pauses.

    The ODI is scored from 0 to 100, with higher scores indicating greater disability.

    The RMDQ is scored from 0 to 24, where higher scores also indicate greater disability.

Study contacts

Contact information is provided by the study sponsor or research team.

nurmuhammet tas

CONTACT

[email protected]

+905323380237

Sponsors and collaborators

Lead sponsor

nurmuhammet tas

Other Gov

Collaborators

  • Erzurum Regional Training & Research Hospital

Registry information

Official study title

Estimation of Pain Level in Patients With Chronic Low Back Pain From Voice Recordings: A Comparative Pilot Study With VAS and Lumbar Function Index

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 22, 2025
Registry last updated
Sep 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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