Pain Monitoring of Herniated Disc Surgery Patients With Oura Ring

Pain Measurement Clinical Trial

Official title:

Pain Monitoring of Herniated Disc Surgery Patients With Oura Ring

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05129007
• Other study ID #: R21071L
• Status: Recruiting
• Start date: November 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2023
• Source: Tampere University Hospital
• Contact: Tommi Bergman, Md
• Phone: 0331166356
• Email: tommi.bergman[@]pshp.fi
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The objective of this research study is to show whether data given by Oura ring could be used to objectively measure patients pain and well-being before and after disc surgery.

Description:

The study will consist of a total 30 disc prolapse patients. Patients are given Oura rings along with other treatment. Patients use Oura rings before and after disc surgery. Patients will also fill Beck Depression Inventory (BDI) and pain detect inquiries in the beginning and in the end of study. Patients symptoms will also be followed daily by electrical symptom diary.

Oura rings technology is based on photoplethysmography( PPG). PPG is a noninvasive method to detect blood volume changes in the microvascular bed of tissue. PPG waveform varies by respiration, sympathetic nervous system activity and thermoregulation. Oura ring gives information of patients activity level, calorie consumption, steps count, resting heart rate,heart rate variability, respiration rate, body temperature, sleep depth and quality of sleep.

Data collected with Oura ring after disc surgery will be compared to data collected before surgery.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2024
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Upcoming herniated disc surgery, ability to give a written informed concent

Exclusion Criteria:

• Sleep apnea, Condition with irregular heart rate, lack of cooperation

Related Conditions & MeSH terms

• Intervertebral Disc Displacement
• Pain Measurement

Intervention

Device:
• Oura ring
Photopletysmography based noninvasive device

Locations

Country	Name	City	State
Finland	Tampere university hospital	Tampere	Pirkanmaa

Sponsors (2)

Lead Sponsor	Collaborator
Tampere University Hospital	Oura health oy

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in heart rate variability	collected from Oura ring	comparison of mean value prior to surgery and one month after surgery
Primary	Change in resting mean heart rate	collected from Oura ring	comparison of mean value prior to surgery and one month after surgery
Primary	Change in ventilatory rate	collected from oura ring	comparison of mean value prior to surgery and one month after surgery
Primary	Change in sleep onset latency	collected from oura ring	comparison of mean value prior to surgery and one month after surgery
Primary	Change in sleep efficiency	percentage of the time spent asleep while in bed collected from oura ring	comparison of mean value prior to surgery and one month after surgery
Primary	Change in number of nighttime awakenings	collected from oura ring	comparison of mean value prior to surgery and one month after surgery
Primary	Change in total sleep time	collected from oura ring	comparison of mean value prior to surgery and one month after surgery
Primary	Change in sleep stages (awake, light sleep, deep sleep and rem sleep)	percentages of each sleep stages collected from oura ring	comparison of mean value prior to surgery and one month after surgery
Primary	Change in symptoms based on symptom diary	Daily symptom diary kept by patient	prior surgery and one month after surgery
Secondary	Change in BDI questionnaire points	BECK Depression Inventory (Scale 1-63, higher scores mean a worse outcome)	one month prior surgery and one month after surgery
Secondary	Change in pain questionnaire	Descriptive questionnaire	one month prior surgery and one month after surgery