- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04108702
Virtual Reality as a New Therapeutic Tool for Chronic Pain
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Lukas Heydrich, MDPhD
- Phone Number: 0041 (0) 31 632 20 04
- Email: lukas.heydrich@gmail.com
Study Locations
-
-
-
Bern, Switzerland
- Recruiting
- Inselspital
-
Contact:
- Lukas Heydrich
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion criteria
- A diagnosis of fibromyalgia according to current diagnostic criteria
- Aged > 18 years old
- Capable of judgement
- Willing to participate in the study (by signing the informed consent form)
- Able to follow the study protocol
Exclusion criteria
- Presence of psychosis or major depression with suicidal risk
- History of alcohol or drug abuse
- Inability to follow the procedures of the study, e.g. due to language problems, inability to wear head-mounted display
- Arrythmia, such as atrial fibrillation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: VR heart
|
Patients will either sit or stand while wearing a head mounted display (HMD, Oculus Rift). A 360° video, showing a neutral body from the back in a neutral room, will be projected onto the HMD. We will record the patients' ECG throughout the entire experiment. Raw data (ECG) are acquired with Arduino and in-house software will detect, in real time, the peak of each R-wave from the recorded ECG data and trigger an additional visual stimulus (e.g. a flashing outline surrounding the virtual body) that flashes on and off SYNCHRONOUSLY with respect to the participant's heartbeat. The silhouette surrounding the virtual body flashes for a duration of 100ms and with a sinusoidal opacity.
Standard multimodal out-patient therapy program (psychological support, physiotherapy, ergotherapy).
|
SHAM_COMPARATOR: VR control
|
Standard multimodal out-patient therapy program (psychological support, physiotherapy, ergotherapy).
Patients will either sit or stand while wearing a head mounted display (HMD, Oculus Rift). A 360° video, showing a neutral body from the back in a neutral room, will be projected onto the HMD. We will record the patients' ECG throughout the entire experiment. Raw data (ECG) are acquired with Arduino and in-house software will detect, in real time, the peak of each R-wave from the recorded ECG data and trigger an additional visual stimulus (e.g. a flashing outline surrounding the virtual body) that flashes on and off ASYNCHRONOUSLY with respect to the participant's heartbeat. The silhouette surrounding the virtual body flashes for a duration of 100ms and with a sinusoidal opacity. |
ACTIVE_COMPARATOR: Standard control
|
Standard multimodal out-patient therapy program (psychological support, physiotherapy, ergotherapy).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain perception using numeric rating scale VR therapy vs. standard therapy
Time Frame: 6 weeks
|
Explore the analgesic effect of the cardio-visual illusion in patients suffering from chronic pain as compared to standard therapy (single-blinded, randomized clinical trial) after 6 weeks using a numeric rating scale (0-10; 0=no pain, 10= max.
pain)
|
6 weeks
|
Pain perception using patient global impression of change VR therapy vs. standard therapy
Time Frame: 6 weeks
|
Explore the analgesic effect of the cardio-visual illusion in patients suffering from chronic pain as compared to standard therapy (single-blinded, randomized clinical trial) after 6 weeks using the Patient global impression of change questionnaire (1-7; 1=very much improved, 7=very much worse).
|
6 weeks
|
Pain perception (algometry) VR therapy vs. standard therapy
Time Frame: 6 weeks
|
Explore the analgesic effect of the cardio-visual illusion in patients suffering from chronic pain as compared to standard therapy (single-blinded, randomized clinical trial) after 6 weeks using an Algometer: The Pain pressure detection threshold to determine hypersensitivity to pain is measured with a standard electronic algometer (Somedic Type II) by bilateral testing on the middle fingers. The electronic algometer is calibrated following the standard protocol as recommended by the manufacturer and set to deliver a steadily increasing pressure (50 kilopascal for 1 s). In this method, the investigators check for the threshold at which non-painful perception of pressure changes to painful perception in response to the gradually increased pressure applied. Low thresholds correspond to high pain sensitivity. |
6 weeks
|
Pain perception (algopeg) VR therapy vs. standard therapy
Time Frame: 6 weeks
|
Explore the analgesic effect of the cardio-visual illusion in patients suffering from chronic pain as compared to standard therapy (single-blinded, randomized clinical trial) after 6 weeks using Algopeg: The algometric measurement method to detect hyperalgesia will be carried out by means of a pressure pain provocation test. For this type of algometry, we will use a standardized peg with a clamping force of exactly 10 Newton at an extension of 5 mm (Type Algopeg).The pressure is applied on the middle finger and the ear lobes for 10 s each and is invariable. The pegs pressure exerted on an ear lobe is perceived as being consistently and clearly above the pain threshold. The patient indicates the pain intensity on a numerical rating scale (NRS) on which 0 stands for "no pain" and 10 stands for "the most intense pain imaginable". High NRS values correspond with high pain sensitivity/hyperalgesia. |
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain perception (numeric rating scale) VR therapy vs. VR control
Time Frame: 6 weeks and 10 weeks
|
Explore the analgesic effect of the cardio-visual illusion in patients suffering from chronic pain as compared to a VR control condition using Numeric rating scale (0-10; 0=no pain, 10= max.
pain).
|
6 weeks and 10 weeks
|
Pain perception (patient global impression of change) VR therapy vs. VR control
Time Frame: 6 weeks and 10 weeks
|
Explore the analgesic effect of the cardio-visual illusion in patients suffering from chronic pain as compared to a VR control condition using the Patient global impression of change questionnaire (1-7; 1=very much improved, 7=very much worse)
|
6 weeks and 10 weeks
|
Pain perception (algometric) VR therapy vs. VR control
Time Frame: 6 weeks and 10 weeks
|
Explore the analgesic effect of the cardio-visual illusion in patients suffering from chronic pain as compared to a VR control condition using algometry: The Pain pressure detection threshold to determine hypersensitivity to pain is measured with a standard electronic algometer (Somedic Type II) by bilateral testing on the middle fingers. The electronic algometer is calibrated following the standard protocol as recommended by the manufacturer and set to deliver a steadily increasing pressure (50 kilopascal for 1 s). In this method, the investigators check for the threshold at which non-painful perception of pressure changes to painful perception in response to the gradually increased pressure applied. Low thresholds correspond to high pain sensitivity. |
6 weeks and 10 weeks
|
Pain perception (algopeg) VR therapy vs. VR control
Time Frame: 6 weeks and 10 weeks
|
Explore the analgesic effect of the cardio-visual illusion in patients suffering from chronic pain as compared to a VR control condition using algopeg: The algometric measurement method to detect hyperalgesia will be carried out by means of a pressure pain provocation test. For this type of algometry, we will use a standardized peg with a clamping force of exactly 10 Newton at an extension of 5 mm (Type Algopeg).The pressure is applied on the middle finger and the ear lobes for 10 s each and is invariable. The pegs pressure exerted on an ear lobe is perceived as being consistently and clearly above the pain threshold. The patient indicates the pain intensity on a numerical rating scale (NRS) on which 0 stands for "no pain" and 10 stands for "the most intense pain imaginable". High NRS values correspond with high pain sensitivity/hyperalgesia. |
6 weeks and 10 weeks
|
Heart rate variability
Time Frame: During each intervention, up to 6 weeks
|
Inter-beat intervals are calculated as the time between two successive R spikes using the ECG signals as acquired during CV stimulation.
Raw data are processed in Matlab® (The MathWorks Inc., Natick, USA) with the HRV Analysis Software (HRVAS: HRV Analysis Software).
For each subject and each condition, we calculate the square root of the mean squared differences of successive beats intervals (RMSSD), which estimates the short term components of HRV and is commonly used over short recording periods.
As HRV pain-related changes occurs mainly in high frequencies (i.e.
power spectrum between 0.15 to 0.40 Hz), we then compute frequency-domain HRV analysis and calculated the power spectrum density using Welch's methods for Fast-Fourier Transform.
|
During each intervention, up to 6 weeks
|
Hamilton anxiety and and depression scale (HADS)
Time Frame: 6 weeks and 10 weeks
|
Study the reduction of psychological distress measured through the Hamilton anxiety and depression scale (Score Anxiety 0-7 normal, 8-10 borderline, 11-21 abnormal; Score depression 0-7 normal, 8-10 borderline, 11-21 abnormal)
|
6 weeks and 10 weeks
|
Beck depression inventory (BDI II)
Time Frame: 6 weeks and 10 weeks
|
Study the reduction of psychological distress measured through the Beck depression inventory.
BDI-II contains 21 questions, each answer being scored on a scale value of 0 to 3. Higher total scores indicate more severe depressive symptoms.
The standardized cutoffs used are: 0-13: minimal depression; 14-19: mild depression; 20-28: moderate depression; 29-63: severe depression.
|
6 weeks and 10 weeks
|
WHO 5 Well Being Index
Time Frame: 6 weeks and 10 weeks
|
Study well-being through the WHO 5 Well Being Index. The WHO-5 consists of five statements, which respondents rate according to the scale below (in relation to the past two weeks). All of the time = 5, At no time = 0. The total raw score, ranging from 0 to 25, is multiplied by 4 to give the final score, with 0 representing the worst imaginable well-being and 100 representing the best imaginable well-being. |
6 weeks and 10 weeks
|
Pain perception (numeric rating scale)
Time Frame: After each intervention, up to 6 weeks
|
Explore the analgesic effect of the cardio-visual illusion in patients suffering from chronic pain as compared to a VR control condition using the numeric rating scale (0-10; 0=no pain, 10= max.
pain).
|
After each intervention, up to 6 weeks
|
Pain perception (algometer)
Time Frame: After each intervention, up to 6 weeks
|
Explore the analgesic effect of the cardio-visual illusion in patients suffering from chronic pain as compared to a VR control condition using algometry: The Pain pressure detection threshold to determine hypersensitivity to pain is measured with a standard electronic algometer (Somedic Type II) by bilateral testing on the middle fingers. The electronic algometer is calibrated following the standard protocol as recommended by the manufacturer and set to deliver a steadily increasing pressure (50 kilopascal for 1 s). In this method, the investigators check for the threshold at which non-painful perception of pressure changes to painful perception in response to the gradually increased pressure applied. Low thresholds correspond to high pain sensitivity. |
After each intervention, up to 6 weeks
|
Pain perception (algopeg)
Time Frame: After each intervention, up to 6 weeks
|
Explore the analgesic effect of the cardio-visual illusion in patients suffering from chronic pain as compared to a VR control condition using algopeg.
The algometric measurement method to detect hyperalgesia will be carried out by means of a pressure pain provocation test.
For this type of algometry, we will use a standardized peg with a clamping force of exactly 10 Newton at an extension of 5 mm (Type Algopeg).The pressure is applied on the middle finger and the ear lobes for 10 s each and is invariable.
The pegs pressure exerted on an ear lobe is perceived as being consistently and clearly above the pain threshold.
The patient indicates the pain intensity on a numerical rating scale (NRS) on which 0 stands for "no pain" and 10 stands for "the most intense pain imaginable".
High NRS values correspond with high pain sensitivity/hyperalgesia.
|
After each intervention, up to 6 weeks
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-01515
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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