Estimation of Pain Level in Patients With Chronic Low Back Pain From Voice Recordings: A Comparative Pilot Study With VAS and Lumbar Function Index
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 110
- 主要终点
- Correlation between voice features and pain level (VAS score)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •Age below 18
- •Illiterate individuals
结局指标
主要结局
Correlation between voice features and pain level (VAS score)
时间窗: 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.
次要结局
- Correlation between voice features and functional impairment (Oswestry Disability Index [ODI] or Roland-Morris Disability Questionnaire [RMDQ])(At the time of enrollment)
研究者
nurmuhammet tas
Principal Investigator
Erzurum Regional Training & Research Hospital