Pain Monitoring of Herniated Disc Surgery Patients With Oura Ring

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.

Study Overview

• Status: Recruiting
• Conditions: Pain Measurement
• Intervention / Treatment: Device: Oura ring

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

• Study Contact: Name: Tommi Bergman, Md; Phone Number: 0331166356; Email: tommi.bergman@pshp.fi
• Study Contact Backup: Name: Jarkko Harju, md, phd; Email: jarkko.harju@fimnet.fi

Study Locations

• Finland
  • Pirkanmaa
    • Tampere, Pirkanmaa, Finland, 33521
      • Recruiting
      • Tampere University Hospital
      • Contact: Tommi Bergman, Md; Phone Number: 0331166356; Email: tommi.bergman@pshp.fi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Adult patients from Finland

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Crossover
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Study group; All patients	Device: Oura ring; Photopletysmography based noninvasive device; Other Names: Pain questionnaire, BDI-questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in heart rate variability	collected from Oura ring	comparison of mean value prior to surgery and one month after surgery
Change in resting mean heart rate	collected from Oura ring	comparison of mean value prior to surgery and one month after surgery
Change in ventilatory rate	collected from oura ring	comparison of mean value prior to surgery and one month after surgery
Change in sleep onset latency	collected from oura ring	comparison of mean value prior to surgery and one month after surgery
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
Change in number of nighttime awakenings	collected from oura ring	comparison of mean value prior to surgery and one month after surgery
Change in total sleep time	collected from oura ring	comparison of mean value prior to surgery and one month after surgery
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
Change in symptoms based on symptom diary	Daily symptom diary kept by patient	prior surgery and one month after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Change in pain questionnaire	Descriptive questionnaire	one month prior surgery and one month after surgery

Collaborators and Investigators

• Sponsor: Tampere University Hospital
• Collaborators: Oura health oy

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2022
• Primary Completion (Anticipated): December 30, 2023
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: September 17, 2021
• First Submitted That Met QC Criteria: November 19, 2021
• First Posted (Actual): November 22, 2021

Study Record Updates

• Last Update Posted (Actual): April 14, 2023
• Last Update Submitted That Met QC Criteria: April 13, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Pain; Herniated disc; Oura ring; Activity measurment
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Hernia; Intervertebral Disc Displacement
• Other Study ID Numbers: R21071L

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No