Condition category
Musculoskeletal Diseases
Date applied
10/02/2011
Date assigned
04/03/2011
Last edited
30/03/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Hong-You Ge

ORCID ID

Contact details

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

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 measures

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

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

http://www.afsafund.org/

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

foundation

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

Results - basic reporting

Publication summary

1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21426569

Publication citations

  1. 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.

Additional files

Editorial Notes