FibromyalgiaPhase 2AVACEN: TESNCT01619579
Investigation of AVACEN Thermal Exchange System for Fibromyalgia Pain
A Phase 2 study testing AVACEN Thermal Exchange System in people with Fibromyalgia, run by Avacen, Inc. at 1 site in United States.
Trial summary
Hypothesis: Daily use of the AVACEN Thermal Exchange System for 4 weeks will show improved Fibromyalgia pain and functioning markers, as assessed by biomarkers and clinical and psychological assessment. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- AVACEN Thermal Exchange System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to May 2013
- Phase
- Phase 2
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fibromyalgia diagnosis
- Over the age of 18
- Understands English
- Not pregnant/planning to become pregnant
- Average pain of 4 or greater over the last week (10 point scale)
- Fibromyalgia pain lasting longer than 6 months
Who cannot join
- Pregnant/Planning to become pregnant
- Major unstable psychiatric illness
- Major, uncontrolled systemic illness for which you may be hospitalized in the next 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a 4 Week AVACEN Treatment on Pain Perception in Fibromyalgia - An Open Label Study
Hypothesis: Daily use of the AVACEN Thermal Exchange System for 4 weeks will show improved Fibromyalgia pain and functioning markers, as assessed by biomarkers and clinical and psychological assessment. This non-invasive device is able to rapidly raise the core body temperature of the user by placing a hand in a vacuum chamber and resting it upon a heating element. The change in body temperature may change the sympathetic nervous system's activity and thereby reduce Fibromyalgia pain.
- Conditions
- Fibromyalgia
- Being tested
- AVACEN Thermal Exchange System
- Keywords
- Fibromyalgia, Pain, Non-Invasive, Arthritis, Rheumatoid Disease
- Medical subject headings
- Fibromyalgia, Pain, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AVACEN Thermal Exchange SystemDevice
Also called AVACEN Treatment Method (ATM) (previously known as the AVACEN Thermal Exchange System [TES] or the AVACEN Thermal Exchange Method [TEM])
Non-invasive device forms vacuum around subject's hand, enabling efficient core body temperature adjustment using heating element inside device.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Subjects with Fibromyalgia undergo twice daily use of the non-invasive device for 4 weeks. Receives: Device: AVACEN Thermal Exchange System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Widespread Pain Index (WPI) Score After 4 Weeks Treatment
Widespread Pain Index (WPI) Score Range is 0 to 19 points. 0 = Lowest pain score (Best Outcome). 19 = Highest pain score (Worst Outcome). Widespread pain was defined as pain occurring in at least 2 contralateral body quadrants, in addition to the axial skeleton for at least 3 consecutive months.
Measured: 4 Weeks
Tender Point Count (TPC) After 4 Weeks Treatment
Tender Point Count (TPC) Score Range is 0 to 18. 0 = Lowest pain score (Best Outcome). 18 = Highest pain score (Worst Outcome). The criteria required confirming tenderness used 4kg of pressure applied to a total of 18 specified tender point sites.
Fibromyalgia is diagnosed with a minimum tenderness count in 11 of 18 points.
Measured: 4 Weeks
Symptom Severity (SS) Score After 4 Weeks Treatment
Symptom Severity (SS) Score Range is 0 to 12. 0 = Lowest pain score (Best Outcome). 12 = Highest pain score (Worst Outcome).
The SS scale identifies the level of severity sum of 4 categories (Fatigue, Waking Unrefreshed, Cognitive Symptoms, Somatic Symptoms) over the past week, using this scale:
0 = no problem
- slight or mild
- moderate
- severe: continuous, life-disturbing
Measured: 4 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2012 (estimated)
- Study startJun 2011
- Primary completionMay 2012
- Study completionMay 2013
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 FibromyalgiaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Avacen, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of California, San Diego, San Diego Veterans Healthcare System
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01619579
- Sponsor's protocol ID
- 110973
- Acronym
- AVACEN: TES
- Status last verified
- Dec 2016
- First submitted
- 12 Jun 2012
- Last updated
- 1 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a 4 Week AVACEN Treatment on Pain Perception in Fibromyalgia - An Open Label Study
- ClinicalTrials.gov ID
- NCT01619579
- Acronym / sponsor ID
- AVACEN: TES / 110973
- Conditions
- Fibromyalgia
- Keywords
- Fibromyalgia, Pain, Non-Invasive, Arthritis, Rheumatoid Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Avacen, Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of California, San Diego, San Diego Veterans Healthcare System
- Study start
- Jun 2011
- Primary completion
- May 2012 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 14 Jun 2012 (estimated)
- Results
- Posted 1 Dec 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hypothesis: Daily use of the AVACEN Thermal Exchange System for 4 weeks will show improved Fibromyalgia pain and functioning markers, as assessed by biomarkers and clinical and psychological assessment. This non-invasive device is able to rapidly raise the core body temperature of the user by placing a hand in a vacuum chamber and resting it upon a heating element. The change in body temperature may change the sympathetic nervous system's activity and thereby reduce Fibromyalgia pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: AVACEN Thermal Exchange SystemSubjects with Fibromyalgia undergo twice daily use of the non-invasive device for 4 weeks. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Fibromyalgia diagnosis
- Over the age of 18
- Understands English
- Not pregnant/planning to become pregnant
- Average pain of 4 or greater over the last week (10 point scale)
Key exclusion criteria (3 listed)
- Pregnant/Planning to become pregnant
- Major unstable psychiatric illness
- Major, uncontrolled systemic illness for which you may be hospitalized in the next 6 months
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 |
|---|---|---|
| AVACEN Thermal Exchange SystemAlso: AVACEN Treatment Method (ATM) (previously known as the AVACEN Thermal Exchange System [TES] or the AVACEN Thermal Exchange Method [TEM])Non-invasive device forms vacuum around subject's hand, enabling efficient core body temperature adjustment using heating element inside device. | Device | Treatment |
Primary outcome
Widespread Pain Index (WPI) Score After 4 Weeks Treatment
Time frame: 4 Weeks
Widespread Pain Index (WPI) Score Range is 0 to 19 points. 0 = Lowest pain score (Best Outcome). 19 = Highest pain score (Worst Outcome). Widespread pain was defined as pain occurring in at least 2 contralateral body quadrants, in addition to the axial skeleton for at least 3 consecutive months.
Tender Point Count (TPC) After 4 Weeks Treatment
Time frame: 4 Weeks
Tender Point Count (TPC) Score Range is 0 to 18. 0 = Lowest pain score (Best Outcome). 18 = Highest pain score (Worst Outcome). The criteria required confirming tenderness used 4kg of pressure applied to a total of 18 specified tender point sites. Fibromyalgia is diagnosed with a minimum tenderness count in 11 of 18 points.
Symptom Severity (SS) Score After 4 Weeks Treatment
Time frame: 4 Weeks
Symptom Severity (SS) Score Range is 0 to 12. 0 = Lowest pain score (Best Outcome). 12 = Highest pain score (Worst Outcome). The SS scale identifies the level of severity sum of 4 categories (Fatigue, Waking Unrefreshed, Cognitive Symptoms, Somatic Symptoms) over the past week, using this scale: 0 = no problem * slight or mild * moderate * severe: continuous, life-disturbing
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Device manufacturer's websiteLink provided by the sponsor.
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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 Phase 2 study testing AVACEN Thermal Exchange System in people with Fibromyalgia, run by Avacen, Inc. 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 6 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 1 Feb 2017. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Dec 2015). 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?
Widespread Pain Index (WPI) Score After 4 Weeks Treatment (time frame: 4 Weeks). The study lists 3 primary outcomes in all. 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 1 Feb 2017.