ISRCTN ISRCTN43167547
DOI https://doi.org/10.1186/ISRCTN43167547
Secondary identifying numbers AFSA Check number 1403
Submission date
10/02/2011
Registration date
04/03/2011
Last edited
30/03/2011
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

Not provided at time of registration

Contact information

Prof Hong-You Ge
Scientific

Fredrik Bajers Vej 7D-3
Aalborg
DK-9220
Denmark

Study information

Study designRandomised single-blind healthy-controlled single-centre trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleFibromyalgia 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
Study hypothesisIt 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(s)Ethics Committee for Region Nordjylland, Denmark, approved on the 8th July 2008 (ref: VN 20080018)
ConditionFibromyalgia syndrome
InterventionManual 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 typeOther
Primary outcome measureLocal 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 measuresExistence 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 study start date01/01/2009
Overall study end date30/12/2010

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participants30 subjects in each group (total = 60)
Participant inclusion criteria1. 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 exclusion criteria1. Pregnancy
2. Drug addiction
3. Infectious diseases
4. Signs of poor cooperation to the study
Recruitment start date01/01/2009
Recruitment end date30/12/2010

Locations

Countries of recruitment

  • Denmark

Study participating centre

Fredrik Bajers Vej 7D-3
Aalborg
DK-9220
Denmark

Sponsor information

The American Fibromyalgia Syndrome Association, Inc. (AFSA) (USA)
Charity

PO Box 32698
Tucson
AZ 85751
United States of America

Website http://www.afsafund.org/
ROR logo "ROR" https://ror.org/00tmwkm13

Funders

Funder type

Charity

The American Fibromyalgia Syndrome Association, Inc. (AFSA) (USA) (ref: Check Number 1403)
Government organisation / Associations and societies (private and public)
Alternative name(s)
The American Fibromyalgia Syndrome Association, Inc., AMERICAN FIBROMYALGIA SYNDROME ASSOCIATION, INC., AFSA
Location
United States of America

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 22/03/2011 Yes No