Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
AFSA Check number 1403
Study information
Scientific title
Fibromyalgia pain reproduction by manual stimulation of active myofascial trigger points as compared to latent myofascial trigger points in health controls in pain intensity and pain area
Acronym
Study hypothesis
It has previously been reported that local and referred pain from active myofascial trigger points (MTPs) in the neck shoulder region contribute to fibromyalgia (FM) pain and that the pain pattern induced from active MTPs can reproduce parts of the spontaneous clinical FM pain pattern. The hypothesis of current study is that the overall spontaneous FM pain pattern can be reproduced by local and referred pain from active MTPs located in different muscles.
Ethics approval
Ethics Committee for Region Nordjylland, Denmark, approved on the 8th July 2008 (ref: VN 20080018)
Study design
Randomised single-blind healthy-controlled single-centre trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Fibromyalgia syndrome
Intervention
Manual identification of MTPs in different muscles was done by snapping palpation (first to locate a taut band of muscle and place the fingertip at right angles and then move the thumb tip back and forth to roll the underlying fibres) to induce local twitch response and flat palpation (use the padded aspect of the thumb at a right angle to the muscle fibres and apply pressure against the underlying tissue or bone) to induce local pain and referred pain. The applied pressure to each point was about 4 kg and lasted for 10 sec.
EMG registration of spontaneous electrical activity (SEA) is the only electrophysiological method to document the existence of an MTP. In the current study, EMG registration of SEA was used to confirm or refute the existence of an MTP following manual identification. During the EMG needle insertion, a thumb palpated the taut band and located the most tender spot on a taut band and applied slightly downward pressure just enough to fix the underlying tissue in place. The total duration of the study for each subject is 1 hour.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Local pain and referred pain pattern from MTPs, together with the locations of the MTPs are
recorded on an anatomic body map. Taken 10 seconds following manual stimulation of an MTP.
Secondary outcome measures
Existence of the spontanous electrical activity with intramuscular electromyography from the MTPs. Taken after manual stimulation of all MTPs in order not to influence the MTP sensitivity by EMG needle insertion.
Overall trial start date
01/01/2009
Overall trial end date
30/12/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients have FM diagnosis confirmed by a physician according to The American
College of Rheumatology (ACR) 1990 criteria for the classification of fibromyalgia
2. Control group:
2.1. No current spontaneous pain
2.2. No major pain experience during the past month prior to experiment
2.3. No pain-related diagnoses (e.g., FM, osteoarthritis, rheumatoid arthritis, low back pain, etc.)
3. Participants are female and aged between 20 - 70 years
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
30 subjects in each group (total = 60)
Participant exclusion criteria
1. Pregnancy
2. Drug addiction
3. Infectious diseases
4. Signs of poor cooperation to the study
Recruitment start date
01/01/2009
Recruitment end date
30/12/2010
Locations
Countries of recruitment
Denmark
Trial participating centre
Fredrik Bajers Vej 7D-3
Aalborg
DK-9220
Denmark
Sponsor information
Organisation
The American Fibromyalgia Syndrome Association, Inc. (AFSA) (USA)
Sponsor details
PO Box 32698
Tucson
AZ 85751
United States of America
Sponsor type
Charity
Website
Funders
Funder type
Charity
Funder name
The American Fibromyalgia Syndrome Association, Inc. (AFSA) (USA) (ref: Check Number 1403)
Alternative name(s)
American Fibromyalgia Syndrome Association, Inc., AFSA
Funding Body Type
private sector organisation
Funding Body Subtype
Trusts, charities, foundations (both publically funded and privately funded)
Location
United States of America
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21426569
Publication citations
-
Results
Ge HY, Wang Y, Fernández-de-las-Peñas C, Graven-Nielsen T, Danneskiold-Samsøe B, Arendt-Nielsen L, Reproduction of overall spontaneous pain pattern by manual stimulation of active myofascial trigger points in fibromyalgia patients., Arthritis Res. Ther., 2011, 13, 2, R48, doi: 10.1186/ar3289.