FibromyalgiaNCT01686074
Motor Control in Chronic Fatigue Syndrome and Fibromyalgia
An observational study of Fibromyalgia and Chronic Fatigue Syndrome, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
This project is a comprehensive study, with main focus on motor control, comparing patients with chronic fatigue syndrome / myalgic encephalopathy (CFS/ME) and/or fibromyalgia syndrome (FMS). Read more about this study
- Who is it for?
- Ages 19 to 49 years
- Conditions the study is for
- Fibromyalgia, Chronic Fatigue Syndrome
- How many people
- 90 participants
- Where
- 1 siteNorway
- Study dates
- Sep 2012to Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 49 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients with chronic fatigue syndrome and fibromyalgia from primary care clinics.
Who may be able to join
- Diagnosis of chronic fatigue syndrome or fibromyalgia
Who cannot join
- patients who already had been treated.
Trial locations and contacts
1 site in 1 country.
Norway1 site
Avdeling for smerte og sammensatte symptomlidelser (ASSL) St Olavs Hospital
Trondheim
About this study
Official title: Motor Control in Chronic Fatigue Syndrome and Fibromyalgia.
This project is a comprehensive study, with main focus on motor control, comparing patients with chronic fatigue syndrome / myalgic encephalopathy (CFS/ME) and/or fibromyalgia syndrome (FMS). Focus of the present project will be on detailed movement analysis in a movement laboratory and involve functional tasks such as walking and standing. Investigations will also comprise muscle activity, reaction time and fine motor control.
- Conditions
- Fibromyalgia, Chronic Fatigue Syndrome
- Keywords
- Motor control, walking, physical activity, Muscle activity
- Medical subject headings
- Fibromyalgia, Fatigue Syndrome, Chronic, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Chronic fatigue syndrome | Not described | |
| fibromyalgia | Not described | |
| chronic fatigue syndrome + fibromyalgia | Not described | |
| healthy sedentary control | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
motor control
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital
- Responsible party
- Sponsor
- Investigators
- Egil A Fors, MD prof, Study director, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01686074
- Sponsor's protocol ID
- 2012/679
- Status last verified
- Feb 2017
- First submitted
- 12 Sep 2012
- Last updated
- 20 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Rasouli O, Stensdotter AK, Van der Meer ALH. TauG-guidance of dynamic balance control during gait initiation in patients with chronic fatigue syndrome and fibromyalgia. Clin Biomech (Bristol). 2016 Aug;37:147-152. doi: 10.1016/j.clinbiomech.2016.07.008. Epub 2016 Jul 22.
PubMed 27474799Rasouli O, Fors EA, Borchgrevink PC, Ohberg F, Stensdotter AK. Gross and fine motor function in fibromyalgia and chronic fatigue syndrome. J Pain Res. 2017 Feb 7;10:303-309. doi: 10.2147/JPR.S127038. eCollection 2017.
PubMed 28223840
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motor Control in Chronic Fatigue Syndrome and Fibromyalgia.
- ClinicalTrials.gov ID
- NCT01686074
- Acronym / sponsor ID
- 2012/679
- Conditions
- Fibromyalgia, Chronic Fatigue Syndrome
- Keywords
- Motor control, walking, physical activity, Muscle activity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital
- Study start
- Sep 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 17 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project is a comprehensive study, with main focus on motor control, comparing patients with chronic fatigue syndrome / myalgic encephalopathy (CFS/ME) and/or fibromyalgia syndrome (FMS). Focus of the present project will be on detailed movement analysis in a movement laboratory and involve functional tasks such as walking and standing. Investigations will also comprise muscle activity, reaction time and fine motor control.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Chronic fatigue syndrome | – | – |
| fibromyalgia | – | – |
| chronic fatigue syndrome + fibromyalgia | – | – |
| healthy sedentary control | – | – |
Who may qualify
- Ages
- 19 to 49 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients with chronic fatigue syndrome and fibromyalgia from primary care clinics.
Key inclusion criteria (1 listed)
- Diagnosis of chronic fatigue syndrome or fibromyalgia
Key exclusion criteria (1 listed)
- patients who already had been treated.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
motor control
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2017.
- Background: PubMed 27474799Rasouli O, Stensdotter AK, Van der Meer ALH. TauG-guidance of dynamic balance control during gait initiation in patients with chronic fatigue syndrome and fibromyalgia. Clin Biomech (Bristol). 2016 Aug;37:147-152. doi: 10.1016/j.clinbiomech.2016.07.008. Epub 2016 Jul 22.
- Results publication: PubMed 28223840Rasouli O, Fors EA, Borchgrevink PC, Ohberg F, Stensdotter AK. Gross and fine motor function in fibromyalgia and chronic fatigue syndrome. J Pain Res. 2017 Feb 7;10:303-309. doi: 10.2147/JPR.S127038. eCollection 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Egil A Fors, MD prof study director
Norwegian University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fibromyalgia and Chronic Fatigue Syndrome, run by Norwegian University of Science and Technology at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
motor control (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01686074, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2017.