Condition category
Musculoskeletal Diseases
Date applied
02/09/2015
Date assigned
24/09/2015
Last edited
22/10/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Fibromyalgia syndrome (FMS) is a common long-term condition, which causes widespread muscle and joint pain all over the body. The exact cause of FMS is unknown, but it is thought that a variety of physical, mental and emotional factors are responsible. One theory is that FMS is to do with an abnormal increase of chemicals in the brain (neurotransmitters), which causes people to feel pain more intensely and are more sensitive to pain. Many studies link fibromyalgia with depression, which is also related to abnormal levels of neurotransmitters in the brain, however little is known about how these two conditions might influence each other. The aim of this study is to find out whether the cortex of the brain (which is responsible for consciousness) is more active in people with FMS than in people with depression with no pain and healthy controls.

Who can participate?
Adults with fibromyalgia syndrome, depression with no pain, and healthy age matched controls.

What does the study involve?
Participants receive two different forms of stimulation. In the first stimulation, painful pressure is applied to the forearm of the patient, and in the second, a word-based memory test (verbal fluency test) is performed. Whilst these stimulations are happening, participants undergo a special type of brain imaging which shows which areas of the brain are active, by looking at the amount of blood flow (functional near-infrared spectroscopy). All participants are also asked to complete questionnaires to measure their levels of pain and emotion.

What are the possible benefits and risks of participating?
Participants receive no direct benefits from the study as it is an observational study. There are no risks of participating in the study.

Where is the study run from?
University of Würzburg and University of Tübingen (Germany)

When is the study starting and how long is it expected to run for?
January 2007 to December 2012

Who is funding the study?
University of Würzburg (Germany)

Who is the main contact?
Dr Nurcan Üçeyler
ueceyler_n@ukw.de

Trial website

Contact information

Type

Scientific

Primary contact

Dr Nurcan Üçeyler

ORCID ID

http://orcid.org/0000-0001-6973-6428

Contact details

Department of Neurology
University of Würzburg
Josef-Schneider-Str. 11
Würzburg
97080
Germany
+49 931 201 24617
ueceyler_n@ukw.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Increased cortical activation upon painful stimulation in fibromyalgia syndrome

Acronym

Study hypothesis

Cortical activation upon painful stimulation is increased in patients with fibryomyalgia syndrome compared to patients with depression and no pain and to healthy controls.

Ethics approval

Würzburg Medical School Ethics Committee, 27/01/2009, ref: 12/09

Study design

Non-interventional single-center study observational study.

Primary study design

Observational

Secondary study design

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Condition

Fibromyalgia

Intervention

Twenty five patients with fibromyalgia syndrome, ten patients with unipolar major depression (MD) without pain, and thirty five healthy controls are recruited for the study. Patients undergo functional near-infrared spectroscopy (fNIRS) whilst being subjected to two stimulations:

1. Painful pressure stimulation at the dorsal forearm
2. Verbal fluency test (VFT) to asses cognitive function using memory recall

All patients underwent neurological examination and all subjects were investigated with questionnaires (pain, depression, FMS, empathy).

Intervention type

Phase

Drug names

Primary outcome measures

Muscular pressure pain: fNIRS measurements were performed during the application of painful pressure on the muscle bulk of the finger extensors of the right side using a calibrated algesiometer. The stimulation conditions were as follows: pressure application for two seconds; pause for ten seconds between two stimuli; total of 40 stimuli, i.e. measurement at baseline and up to 8 minutes after first stimulation.

Secondary outcome measures

Verbal fluency test (VFT): The VFT paradigm consisted of three conditions. Subjects were asked to produce as many different nouns as possible a) starting with a certain letter (A, F, and S), or b) belonging to the same category (animals, fruits, and flowers) or c) to name the days of the week as a control condition. Each condition lasted for 30 sec followed by 30 sec rest. Subjects worked on nine blocks in total (3 x letters, 3 x categories, 3 x week days), i.e. measurement at baseline and up to 9 minutes after start.

Overall trial start date

01/01/2007

Overall trial end date

31/12/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 18 years or over
2. Patients with:
2.1. Fibromyalgia syndrome
2.2. Unipolar major depression (MD) without pain
2.3.Healthy controls

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

25

Participant exclusion criteria

1. Other possible differential diagnoses (e.g. rheumatoid arthritis; post-surgery pain)
2. Current or prior cerebral disease (e.g. stroke, cerebral hemorrhage, head trauma)
3. Any clinically relevant psychiatric disorder (examined by systematic psychiatric interview)

Recruitment start date

01/01/2007

Recruitment end date

31/12/2011

Locations

Countries of recruitment

Germany

Trial participating centre

University of Würzburg
Department of Neurology Sanderring 2
Würzburg
97080
Germany

Trial participating centre

University of Würzburg
Department of Psychiatry Sanderring 2
Würzburg
97080
Germany

Trial participating centre

University of Tübingen
Department of Psychiatry Geschwister-Scholl-Platz
Tübingen
72070
Germany

Sponsor information

Organisation

University of Würzburg

Sponsor details

Department of Neurology
Josef-Schneider-Str. 11
Würzburg
97080
Germany

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

University of Würzburg (EFIC-Grünenthal Grant and intramural funds)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

We have submitted our manuscript and are awaiting publication in BMC Musculoskeletal Disorders.
After publication of the paper we are planning to disseminate our data on scientific congresses (e.g. German Pain Society).

Intention to publish date

30/09/2015

Participant level data

Available on request

Results - basic reporting

Publication summary

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26486985

Publication citations

Additional files

Editorial Notes