Investigation of AVACEN Thermal Exchange System for Fibromyalgia Pain

NCT01619579 | Completed Phase 2 Results DMC

• 1 other identifier: 110973
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Fibromyalgia; Pain; Non-Invasive; Arthritis; Rheumatoid Disease

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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

  4 Weeks

Study Arms (1)

Treatment

EXPERIMENTAL

Subjects with Fibromyalgia undergo twice daily use of the non-invasive device for 4 weeks.

Device: AVACEN Thermal Exchange System

Interventions

AVACEN Thermal Exchange System DEVICE

Non-invasive device forms vacuum around subject's hand, enabling efficient core body temperature adjustment using heating element inside device.

Also known as: AVACEN Treatment Method (ATM) (previously known as the AVACEN Thermal Exchange System [TES] or the AVACEN Thermal Exchange Method [TEM])

Treatment

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnant/Planning to become pregnant
• Major unstable psychiatric illness
• Major, uncontrolled systemic illness for which you may be hospitalized in the next 6 months

Sponsors & Collaborators

• Avacen, Inc.: lead
• University of California, San Diego: collaborator
• San Diego Veterans Healthcare System: collaborator

Study Sites (1)

VA San Diego

La Jolla, California, 92093, United States

Location

Related Links

• Device manufacturer's website
• VA San Diego website. Location study is conducted.

MeSH Terms

Conditions

Fibromyalgia; Pain; Arthritis

Interventions

Microscopy, Electron, Transmission

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Joint Diseases

Intervention Hierarchy (Ancestors)

Microscopy, Electron; Microscopy; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Results Point of Contact

• Title: Tobias Moeller-Bertram, MD
• Organization: VA Medical Center & UCSD Center for Pain Medicine

tmoellerbertram@ucsd.edu

858-552-8585

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2012
• First Posted: June 14, 2012
• Study Start: June 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2013
• Last Updated: February 1, 2017
• Results First Posted: December 1, 2015

Record last verified: 2016-12

Locations

US (1)