Chronic Low Back Pain (CLBP)NCT07078019
Voice-Derived Acoustic Features and Pain Intensity in Chronic Low Back Pain
An observational study of Chronic Low Back Pain (CLBP), run by nurmuhammet tas at 1 site in Turkey (Türkiye).
Trial summary
This observational study investigated whether characteristics of a person's voice are associated with pain intensity in adults with chronic low back pain and whether voice recordings can help predict individual pain levels. The study included 110 adults aged 18-70 years with chronic low back pain. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Low Back Pain (CLBP)
- What is being tested?
- Voice Recording Procedure
- How many people
- 110 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Jul 2025to 30 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consisted of 110 adults aged 18-70 years with chronic low back pain who were evaluated at Erzurum City Hospital, Türkiye. Participants were selected using quota-balanced, non-probability sampling to include 10 individuals at each Numerical Rating Scale (NRS) pain intensity level from 0 to 10. All participants underwent standardized voice recording and completed pain intensity and functional disability assessments during a single study visit.
Who may be able to join
- Adults aged 18-70 years.
- Presence of chronic low back pain.
- Ability to provide informed consent.
- Ability to complete the Numerical Rating Scale (NRS), Oswestry Disability Index (ODI), and standardized voice recording procedure.
Who cannot join
- Individuals without chronic low back pain.
- Individuals unable to provide informed consent.
- Individuals unable to complete the required clinical assessments or voice recording procedure.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Voice-Derived Acoustic Features and Pain Intensity in Chronic Low Back Pain: An Exploratory Prediction Study
This observational study investigated whether characteristics of a person's voice are associated with pain intensity in adults with chronic low back pain and whether voice recordings can help predict individual pain levels.
The study included 110 adults aged 18-70 years with chronic low back pain. Participants were selected to represent the full range of pain intensity scores from 0 to 10, with 10 participants at each level.
Read more
Each participant reported their current pain intensity using the Numerical Rating Scale (NRS) and completed the Oswestry Disability Index (ODI) questionnaire to assess limitations in daily activities. Participants also read a standardized text aloud while their voice was recorded using a smartphone.
The recordings were analyzed to measure acoustic characteristics, including voice pitch, pitch variability, jitter, shimmer, voice quality, speaking duration, and pauses. Researchers examined whether these characteristics were associated with pain intensity and functional disability. Statistical prediction models were also evaluated to determine whether voice characteristics could estimate individual pain scores.
No experimental treatment was administered as part of this study. The study aimed to improve understanding of the potential usefulness and limitations of voice analysis as a non-invasive method for assessing pain in people with chronic low back pain.
Read the detailed description
Study Design and Objectives
This was a single-center, observational, cross-sectional exploratory prediction study conducted in adults with chronic low back pain. The study aimed to investigate associations between conventional acoustic features extracted from voice recordings and self-reported pain intensity, and to determine whether these features could predict individual pain scores.
Participants and Sampling
A total of 110 adults aged 18-70 years with chronic low back pain were included. A quota-balanced, non-probability sampling strategy was used to obtain 10 participants at each level of the 0-10 Numerical Rating Scale (NRS), ensuring representation across the full range of reported pain intensity.
Clinical Assessments
Participants reported their current pain intensity using the 11-point NRS, ranging from 0 (no pain) to 10 (worst imaginable pain). Functional disability was assessed using the Oswestry Disability Index (ODI). Demographic and anthropometric information, including age, sex, height, weight, and body mass index, was recorded.
Voice Recording Procedure
Voice recordings were obtained using the built-in recording application of a Samsung Galaxy A71 smartphone under standardized outpatient clinic conditions. Two reading protocols were used: a consent-related text protocol and an emotionally neutral text protocol. Participants read the assigned text aloud using their habitual speaking voice.
Recordings were analyzed using Praat software. Eleven conventional acoustic features were extracted: total recording duration, mean intensity, mean fundamental frequency (F0), F0 standard deviation, local jitter, local shimmer, mean harmonics-to-noise ratio, pause count, total pause duration, pause ratio, and articulation time.
Recording Quality Control
All recordings underwent technical quality assessment and were classified as good, moderate, or poor. Ninety recordings were classified as good quality and 20 as moderate quality. No recordings were classified as poor, and all 110 participants were included in the primary analyses.
Statistical Analysis
Associations between acoustic features and pain intensity were evaluated using Spearman correlation and multivariable linear regression adjusted for age, sex, and body mass index. The Benjamini-Hochberg false discovery rate procedure was used to account for multiple comparisons.
The ability of acoustic features to predict individual NRS scores was evaluated using ridge regression with repeated nested five-fold cross-validation. Four prediction approaches were compared: a reference baseline model, a clinical model incorporating demographic and anthropometric variables, a voice-based model incorporating acoustic features, and a combined clinical and acoustic model.
Sensitivity analyses examined the influence of reading protocol and recording quality on the associations and predictive performance.
Interpretation
The study was designed to assess associations and predictive performance rather than the clinical effectiveness of an intervention. No experimental treatment was administered. Voice-derived acoustic features were evaluated as potential non-invasive markers of pain intensity, with particular attention to their predictive accuracy and methodological limitations.
- Conditions
- Chronic Low Back Pain (CLBP)
- Being tested
- Voice Recording Procedure
- Keywords
- Chronic low back pain, Voice analysis, Oswestry Disability Index, Acoustic biomarkers, Pain assessment, NRS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Voice Recording ProcedureOther
Participants underwent standardized voice recording using the built-in recording application of a Samsung Galaxy A71 smartphone. Two reading protocols were used: an emotionally neutral text and a consent-related text. Participants read the assigned text aloud using their habitual speaking voice. Recordings were subsequently analyzed using Praat software to extract acoustic features, including fundamental frequency, intensity, jitter, shimmer, harmonics-to-noise ratio, recording duration, and pause-related measures. The recording procedure was non-invasive and did not involve any therapeutic intervention.
| Study group | Role | What they receive |
|---|---|---|
| Adults With Chronic Low Back Pain | A total of 110 adults aged 18-70 years with chronic low back pain were included in this observational, cross-sectional study. Quota-balanced sampling was used to include 10 participants at each Numerical Rating Scale (NRS) pain intensity level from 0 to 10. All participants underwent standardized voice recording and completed pain intensity and functional disability assessments. No experimental treatment was administered. Receives: Other: Voice Recording Procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association Between Voice-Derived Acoustic Features and Pain Intensity (NRS)
Associations between 11 voice-derived acoustic features and pain intensity measured using the Numerical Rating Scale (NRS; 0-10, with higher scores indicating greater pain). Associations were assessed using Spearman correlation and multivariable linear regression adjusted for age, sex, and body mass index, with false discovery rate correction for multiple comparisons.
Measured: At baseline (single study visit)
Secondary outcomes (2)
Association Between Voice-Derived Acoustic Features and Functional Disability (ODI)
Association between voice-derived acoustic features and functional disability assessed using the Oswestry Disability Index (ODI). The ODI measures limitations in daily activities associated with low back pain, with higher scores indicating greater disability. Associations were explored using statistical correlation analyses.
Measured: At baseline (single study visit)
Predictive Performance of Voice-Derived Acoustic Features for NRS Pain Scores
Performance of ridge regression models for predicting individual NRS pain scores from voice-derived acoustic features, evaluated using repeated nested five-fold cross-validation. Prediction performance was assessed using mean absolute error (MAE), root mean squared error (RMSE), and coefficient of determination (R²), with comparisons against clinical and baseline prediction models.
Measured: At baseline (single study visit; prediction models evaluated after data collection)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start11 Jul 2025
- Primary completion30 Sep 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low Back Pain (CLBP)Studies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- nurmuhammet tas
- Sponsor type
- Other government
- Collaborators
- Erzurum Regional Training & Research Hospital
- Responsible party
- Sponsor-investigator, nurmuhammet tas, Erzurum Regional Training & Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07078019
- Sponsor's protocol ID
- erzurum rtrh4
- Status last verified
- Oct 2026
- First submitted
- 12 Jul 2025
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made publicly available due to participant privacy and confidentiality considerations, particularly because the study includes voice recordings that may contain potentially identifiable information. Study findings will be reported in aggregate form.
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Voice-Derived Acoustic Features and Pain Intensity in Chronic Low Back Pain: An Exploratory Prediction Study
- ClinicalTrials.gov ID
- NCT07078019
- Acronym / sponsor ID
- erzurum rtrh4
- Conditions
- Chronic Low Back Pain (CLBP)
- Keywords
- Chronic low back pain, Voice analysis, Oswestry Disability Index, Acoustic biomarkers, Pain assessment, NRS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- nurmuhammet tasOther government
- Collaborators
- Erzurum Regional Training & Research Hospital
- Study start
- 11 Jul 2025 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 22 Jul 2025 (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.
This observational study investigated whether characteristics of a person's voice are associated with pain intensity in adults with chronic low back pain and whether voice recordings can help predict individual pain levels.
The study included 110 adults aged 18-70 years with chronic low back pain. Participants were selected to represent the full range of pain intensity scores from 0 to 10, with 10 participants at each level.
Each participant reported their current pain intensity using the Numerical Rating Scale (NRS) and completed the Oswestry Disability Index (ODI) questionnaire to assess limitations in daily activities. Participants also read a standardized text aloud while their voice was recorded using a smartphone.
The recordings were analyzed to measure acoustic characteristics, including voice pitch, pitch variability, jitter, shimmer, voice quality, speaking duration, and pauses. Researchers examined whether these characteristics were associated with pain intensity and functional disability. Statistical prediction models were also evaluated to determine whether voice characteristics could estimate individual pain scores.
No experimental treatment was administered as part of this study. The study aimed to improve understanding of the potential usefulness and limitations of voice analysis as a non-invasive method for assessing pain in people with chronic low back pain.
Detailed description
Study Design and Objectives
This was a single-center, observational, cross-sectional exploratory prediction study conducted in adults with chronic low back pain. The study aimed to investigate associations between conventional acoustic features extracted from voice recordings and self-reported pain intensity, and to determine whether these features could predict individual pain scores.
Participants and Sampling
A total of 110 adults aged 18-70 years with chronic low back pain were included. A quota-balanced, non-probability sampling strategy was used to obtain 10 participants at each level of the 0-10 Numerical Rating Scale (NRS), ensuring representation across the full range of reported pain intensity.
Clinical Assessments
Participants reported their current pain intensity using the 11-point NRS, ranging from 0 (no pain) to 10 (worst imaginable pain). Functional disability was assessed using the Oswestry Disability Index (ODI). Demographic and anthropometric information, including age, sex, height, weight, and body mass index, was recorded.
Voice Recording Procedure
Voice recordings were obtained using the built-in recording application of a Samsung Galaxy A71 smartphone under standardized outpatient clinic conditions. Two reading protocols were used: a consent-related text protocol and an emotionally neutral text protocol. Participants read the assigned text aloud using their habitual speaking voice.
Recordings were analyzed using Praat software. Eleven conventional acoustic features were extracted: total recording duration, mean intensity, mean fundamental frequency (F0), F0 standard deviation, local jitter, local shimmer, mean harmonics-to-noise ratio, pause count, total pause duration, pause ratio, and articulation time.
Recording Quality Control
All recordings underwent technical quality assessment and were classified as good, moderate, or poor. Ninety recordings were classified as good quality and 20 as moderate quality. No recordings were classified as poor, and all 110 participants were included in the primary analyses.
Statistical Analysis
Associations between acoustic features and pain intensity were evaluated using Spearman correlation and multivariable linear regression adjusted for age, sex, and body mass index. The Benjamini-Hochberg false discovery rate procedure was used to account for multiple comparisons.
The ability of acoustic features to predict individual NRS scores was evaluated using ridge regression with repeated nested five-fold cross-validation. Four prediction approaches were compared: a reference baseline model, a clinical model incorporating demographic and anthropometric variables, a voice-based model incorporating acoustic features, and a combined clinical and acoustic model.
Sensitivity analyses examined the influence of reading protocol and recording quality on the associations and predictive performance.
Interpretation
The study was designed to assess associations and predictive performance rather than the clinical effectiveness of an intervention. No experimental treatment was administered. Voice-derived acoustic features were evaluated as potential non-invasive markers of pain intensity, with particular attention to their predictive accuracy and methodological limitations.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults With Chronic Low Back Pain | – | Other: Voice Recording ProcedureA total of 110 adults aged 18-70 years with chronic low back pain were included in this observational, cross-sectional study. Quota-balanced sampling was used to include 10 participants at each Numerical Rating Scale (NRS) pain intensity level from 0 to 10. All participants underwent standardized voice recording and completed pain intensity and functional disability assessments. No experimental treatment was administered. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consisted of 110 adults aged 18-70 years with chronic low back pain who were evaluated at Erzurum City Hospital, Türkiye. Participants were selected using quota-balanced, non-probability sampling to include 10 individuals at each Numerical Rating Scale (NRS) pain intensity level from 0 to 10. All participants underwent standardized voice recording and completed pain intensity and functional disability assessments during a single study visit.
Key inclusion criteria (4 listed)
- Adults aged 18-70 years.
- Presence of chronic low back pain.
- Ability to provide informed consent.
- Ability to complete the Numerical Rating Scale (NRS), Oswestry Disability Index (ODI), and standardized voice recording procedure.
Key exclusion criteria (3 listed)
- Individuals without chronic low back pain.
- Individuals unable to provide informed consent.
- Individuals unable to complete the required clinical assessments or voice recording procedure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Voice Recording ProcedureParticipants underwent standardized voice recording using the built-in recording application of a Samsung Galaxy A71 smartphone. Two reading protocols were used: an emotionally neutral text and a consent-related text. Participants read the assigned text aloud using their habitual speaking voice. Recordings were subsequently analyzed using Praat software to extract acoustic features, including fundamental frequency, intensity, jitter, shimmer, harmonics-to-noise ratio, recording duration, and pause-related measures. The recording procedure was non-invasive and did not involve any therapeutic intervention. | Other | Adults With Chronic Low Back Pain |
Primary outcome
Association Between Voice-Derived Acoustic Features and Pain Intensity (NRS)
Time frame: At baseline (single study visit)
Associations between 11 voice-derived acoustic features and pain intensity measured using the Numerical Rating Scale (NRS; 0-10, with higher scores indicating greater pain). Associations were assessed using Spearman correlation and multivariable linear regression adjusted for age, sex, and body mass index, with false discovery rate correction for multiple comparisons.
2 secondary outcomes
Association Between Voice-Derived Acoustic Features and Functional Disability (ODI)
Time frame: At baseline (single study visit)
Predictive Performance of Voice-Derived Acoustic Features for NRS Pain Scores
Time frame: At baseline (single study visit; prediction models evaluated after data collection)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be made publicly available due to participant privacy and confidentiality considerations, particularly because the study includes voice recordings that may contain potentially identifiable information. Study findings will be reported in aggregate form.
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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. This study is not recruiting at the moment.
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 Chronic Low Back Pain (CLBP), run by nurmuhammet tas at 1 site in Turkey (Türkiye).
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 4 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: finished, as of the sponsor's last update on 28 Oct 2026. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Association Between Voice-Derived Acoustic Features and Pain Intensity (NRS) (time frame: At baseline (single study visit)). 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 28 Oct 2026.