Increased brain activation after painful stimulation of the forearm muscles in patients with fibromyalgia syndrome

ISRCTN	ISRCTN15015327
DOI	https://doi.org/10.1186/ISRCTN15015327
Secondary identifying numbers	N/A

Submission date: 02/09/2015
Registration date: 24/09/2015
Last edited: 22/10/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Contact information

Dr Nurcan Üçeyler
Scientific

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

ORCID ID	0000-0001-6973-6428
Phone	+49 931 201 24617
Email	ueceyler_n@ukw.de

Study information

Study design	Non-interventional single-center study observational study.
Primary study design	Observational
Secondary study design
Study setting(s)	Hospital
Study type	Other
Scientific title	Increased cortical activation upon painful stimulation in fibromyalgia syndrome
Study objectives	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(s)	Würzburg Medical School Ethics Committee, 27/01/2009, ref: 12/09
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/01/2007
Completion date	31/12/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	25
Key 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
Key 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)
Date of first enrolment	01/01/2007
Date of final enrolment	31/12/2011

Locations

Countries of recruitment

Germany

Study participating centres

University of Würzburg

Department of Neurology
Sanderring 2
Würzburg
97080
Germany

University of Würzburg

Department of Psychiatry
Sanderring 2
Würzburg
97080
Germany

University of Tübingen

Department of Psychiatry
Geschwister-Scholl-Platz
Tübingen
72070
Germany

Sponsor information

University of Würzburg
University/education

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

"ROR"	https://ror.org/03pvr2g57

Funders

Funder type

University/education

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

No information available

Results and Publications

Intention to publish date	30/09/2015
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
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).
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	20/10/2015		Yes	No