Pain, AcuteNCT03187132
Development and Validation of a Digital Pain-Reduction Kit for Musculoskeletal Injuries
A study testing Digital Pain Reduction Kit in people with Pain, Acute and Pain, Chronic, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial summary
This study will test the effectiveness of an evidence-based, multi-modal, "digital pain-reduction kit" as a non-pharmacological supplement to managing patients with pain due to musculoskeletal injuries. Outpatients will be randomized to receive either the pain reduction kit or active control. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Acute, Pain, Chronic
- What is being tested?
- Digital Pain Reduction Kit
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 245 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Apr 2018to 20 May 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, age 18 or older
- Seeking care for a musculoskeletal injury
- Experiencing pain greater than 3 out of 10 on a visual analog scale
- English or Spanish speaking
- Owns a compatible Android or iOS smartphone device (excluding tablets)
Who cannot join
- Unable to understand the goals of the study due to cognitive difficulty
- Use of a cardiac pacemaker, implanted defibrillator, or other implanted metallic or electronic device or high-frequency surgical equipment. (contraindication for TENS units)
- Pregnant (contraindication for TENS unit)
- Current diagnosis of epilepsy, dementia, or other neurological disease that may prevent use of VR hardware or software
- Hypersensitivity to flashing light or motion
- Injury to the eyes, face, neck, or arms that prevents comfortable use of VR hardware or software, or safe use of other study hardware (e.g., open sores, wounds, or skin rash on face)
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars-Sinai Medical Center
Los Angeles, California, 90048
About this study
This study will test the effectiveness of an evidence-based, multi-modal, "digital pain-reduction kit" as a non-pharmacological supplement to managing patients with pain due to musculoskeletal injuries. Outpatients will be randomized to receive either the pain reduction kit or active control. The kit will contain a virtual reality (VR) headset, therapeutic VR visualization software, and a low-cost wearable transcutaneous electrical nerve stimulation (TENS) unit. Clinical staff will monitor progress and provide scheduled coaching and outreach to patients in the intervention group. The control group will receive the low-cost wearable transcutaneous electrical nerve stimulation (TENS) unit alone; they will not receive VR or remote coaching. Study devices will be delivered to the patient's home with instructions for use; patients will receive remote clinical and technical support. Patients will be followed for 60 days and monitored for functional status, pain levels, use of pain medications (including opioids), satisfaction with care, and time to returning to work.
- Conditions
- Pain, Acute, Pain, Chronic
- Being tested
- Digital Pain Reduction Kit, Active Control
- Keywords
- virtual reality, transcutaneous electrical nerve stimulation, analgesia
- Medical subject headings
- Acute Pain, Chronic Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Pain Reduction KitDevice
A two-component intervention consisting of (1) virtual reality, experiences lasting 3-30 minutes used to distract individuals from pain and to teach skills related to chronic pain; (2) TENS unit, used to reduce acute localized pain.
Active ControlDevice
An active control TENS unit used to reduce acute localized pain.
| Study group | Role | What they receive |
|---|---|---|
| Digital Pain Reduction Kit | Experimental | Participants in the experimental arm will be assigned the digital pain reduction kit consisting of a transcutaneous electrical nerve stimulation unit to be used as needed and a virtual reality headset to be used as needed or at least once a day. Remote clinical support is provided for patients who volunteer information to be viewed by clinicians. Receives: Device: Digital Pain Reduction Kit |
| Active Control | Active comparator | Participants in the active control arm will receive standard of care as provided by their physician in addition to a transcutaneous electrical nerve stimulation unit. Receives: Device: Active Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
PROMIS - Physical Function Short Form 8b
PROMIS Physical Function instruments measure self-reported capability rather than actual performance of physical activities. A single Physical Function capability score is obtained from a short form. The forms are universal rather than disease-specific. A higher PROMIS T-score represents more of the concept. For Physical Function, a T-score of 60 is one SD better than average. By comparison, a Physical Function T-score of 40 is one SD worse than average.
Measured: 60 days
Secondary outcomes (4)
PROMIS - Pain Interference Short Form 8a
PROMIS - Pain Interference instruments assess self-reported consequences of pain on relevant aspects of one's life. This includes the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities. A single Pain interference score is obtained from a short form. The forms are universal rather than disease-specific. A higher PROMIS T-score represents more of the concept. For Pain Interference, a T-score of 60 is one SD higher pain than average. By comparison, a Pain Interference T-score of 40 is one SD lower pain than average.
Measured: 60 days
Work Productivity and Activity Impairment Questionnaire : Lower Back Pain (WPAI:SHP v2.0)
The WPAI:LBP was created as a patient-reported quantitative assessment of the amount of absenteeism, presenteeism and daily activity impairment attributable to Lower Back Pain. The WPAI:LBP productivity loss subscale consists of a single item ("During the past seven days, how much did your pain affect your productivity while you were working?") with a 0-10 response scale where 0 indicates pain had no effect, and 10 indicates pain completely prevented work. The presenteeism sub-scale consists of a comparison two items, yielding percent of hours missed due to pain. Finally, the activity impairment subscale consists of one item("During the past seven days, how much did your pain affect your ability to do your regular daily activities, other than work at a job?") with a 0-10 response scale where 0 indicated pain had no effect, and 10 indicated pain completely prevented daily activities.
Measured: 60 days
Patient Satisfaction Questionnaire (PSQ) 18
Patient Satisfaction Questionnaire (PSQ) 18 which includes questions in 3 relevant domains: general satisfaction, communication, and accessibility of care. All subscales are scored so that high scores reflect satisfaction with medical care. Each domain averages responses to items with a range of 1-5, with 5 indicating the highest satisfaction.
Measured: 60 days
Binary, Self-reported Opioid Use
Investigators will examine opioid utilization using binary self-reported opioid use (e.g. 0=did not use opioidss;1=used opioids).
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2017
- Study start3 Apr 2018
- Primary completion20 May 2020
- Study completion20 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pain, AcuteStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 245 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Travelers, Samsung, AppliedVR Inc., Bayer, Hollywog
- Responsible party
- Principal investigator, Brennan Spiegel, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03187132
- Sponsor's protocol ID
- Pro00049015
- Status last verified
- Jul 2021
- First submitted
- 12 Jun 2017
- Last updated
- 5 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a Digital Pain-Reduction Kit for Musculoskeletal Injuries
- ClinicalTrials.gov ID
- NCT03187132
- Acronym / sponsor ID
- Pro00049015
- Conditions
- Pain, Acute, Pain, Chronic
- Keywords
- virtual reality, transcutaneous electrical nerve stimulation, analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 245 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Collaborators
- Travelers, Samsung, AppliedVR Inc., Bayer, Hollywog
- Study start
- 3 Apr 2018 (actual)
- Primary completion
- 20 May 2020 (actual)
- Study completion
- 20 May 2020 (actual)
- First posted
- 14 Jun 2017 (actual)
- Results
- Posted 5 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will test the effectiveness of an evidence-based, multi-modal, "digital pain-reduction kit" as a non-pharmacological supplement to managing patients with pain due to musculoskeletal injuries. Outpatients will be randomized to receive either the pain reduction kit or active control. The kit will contain a virtual reality (VR) headset, therapeutic VR visualization software, and a low-cost wearable transcutaneous electrical nerve stimulation (TENS) unit. Clinical staff will monitor progress and provide scheduled coaching and outreach to patients in the intervention group. The control group will receive the low-cost wearable transcutaneous electrical nerve stimulation (TENS) unit alone; they will not receive VR or remote coaching. Study devices will be delivered to the patient's home with instructions for use; patients will receive remote clinical and technical support. Patients will be followed for 60 days and monitored for functional status, pain levels, use of pain medications (including opioids), satisfaction with care, and time to returning to work.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Digital Pain Reduction Kit | Experimental | Device: Digital Pain Reduction KitParticipants in the experimental arm will be assigned the digital pain reduction kit consisting of a transcutaneous electrical nerve stimulation unit to be used as needed and a virtual reality headset to be used as needed or at least once a day. Remote clinical support is provided for patients who volunteer information to be viewed by clinicians. |
| Active Control | Active comparator | Device: Active ControlParticipants in the active control arm will receive standard of care as provided by their physician in addition to a transcutaneous electrical nerve stimulation unit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, age 18 or older
- Seeking care for a musculoskeletal injury
- Experiencing pain greater than 3 out of 10 on a visual analog scale
Key exclusion criteria (6 listed)
- Unable to understand the goals of the study due to cognitive difficulty
- Use of a cardiac pacemaker, implanted defibrillator, or other implanted metallic or electronic device or high-frequency surgical equipment. (contraindication for TENS units)
- Pregnant (contraindication for TENS unit)
- Current diagnosis of epilepsy, dementia, or other neurological disease that may prevent use of VR hardware or software
- Hypersensitivity to flashing light or motion
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 |
|---|---|---|
| Digital Pain Reduction KitA two-component intervention consisting of (1) virtual reality, experiences lasting 3-30 minutes used to distract individuals from pain and to teach skills related to chronic pain; (2) TENS unit, used to reduce acute localized pain. | Device | Digital Pain Reduction Kit |
| Active ControlAn active control TENS unit used to reduce acute localized pain. | Device | Active Control |
Primary outcome
PROMIS - Physical Function Short Form 8b
Time frame: 60 days
PROMIS Physical Function instruments measure self-reported capability rather than actual performance of physical activities. A single Physical Function capability score is obtained from a short form. The forms are universal rather than disease-specific. A higher PROMIS T-score represents more of the concept. For Physical Function, a T-score of 60 is one SD better than average. By comparison, a Physical Function T-score of 40 is one SD worse than average.
4 secondary outcomes
PROMIS - Pain Interference Short Form 8a
Time frame: 60 days
Work Productivity and Activity Impairment Questionnaire : Lower Back Pain (WPAI:SHP v2.0)
Time frame: 60 days
Patient Satisfaction Questionnaire (PSQ) 18
Time frame: 60 days
Binary, Self-reported Opioid Use
Time frame: 60 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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?
A study testing Digital Pain Reduction Kit in people with Pain, Acute and Pain, Chronic, run by Cedars-Sinai Medical Center at 1 site in United States.
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 7 inclusion and 6 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 5 Aug 2021. 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 United States. 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?
Yes. Results are posted in the registry (first posted 5 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
PROMIS - Physical Function Short Form 8b (time frame: 60 days). 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 5 Aug 2021; AzTrials last refreshed its copy on 30 Oct 2026.