Role of myofascial trigger points in fibromyalgia
| 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 of protocol
Not provided at time of registration
Contact information
Prof Hong-You Ge
Scientific
Scientific
Fredrik Bajers Vej 7D-3
Aalborg
DK-9220
Denmark
Study information
| Study design | Randomised single-blind healthy-controlled single-centre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study objectives | 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(s) | Ethics Committee for Region Nordjylland, Denmark, approved on the 8th July 2008 (ref: VN 20080018) |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/01/2009 |
| Completion date | 30/12/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 30 subjects in each group (total = 60) |
| Key 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 |
| Key exclusion criteria | 1. Pregnancy 2. Drug addiction 3. Infectious diseases 4. Signs of poor cooperation to the study |
| Date of first enrolment | 01/01/2009 |
| Date of final enrolment | 30/12/2010 |
Locations
Countries of recruitment
- Denmark
Study participating centre
Fredrik Bajers Vej 7D-3
Aalborg
DK-9220
Denmark
DK-9220
Denmark
Sponsor information
The American Fibromyalgia Syndrome Association, Inc. (AFSA) (USA)
Charity
Charity
PO Box 32698
Tucson
AZ 85751
United States of America
| Website | http://www.afsafund.org/ |
|---|---|
"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)
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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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 |
