FibromyalgiaDOUFISPORTNCT02486965
Impact of a Specific Training Program on the Neuromodulation of Pain in Fibromyalgia Subjects
A study testing thermode (TSA-II model), Adapted Physical Activity and Physical activity in people with Fibromyalgia, run by University Hospital, Brest at 2 sites in France.
Trial summary
Fibromyalgia affects 1.4 now 2.2% of the general population whose symptom is the presence of widespread pain in all four quadrants of the body. Currently, there is no causal treatment of fibromyalgia syndrome. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- thermode (TSA-II model), Adapted Physical Activity and Physical activity
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesFrance
- Study dates
- 7 Oct 2015to 21 Oct 2021
- Phase
- Interventional
- 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 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of fibromyalgia is clearly established by the criteria of the American College of Rheumatology (ACR).
- Body Mass Index (BMI) between 18.5 and 24.9 kg / m² (normal weight at HAS).
- Spontaneous pain intensity greater than 3/10 on a VAS. Pain triggered by palpation must be equal to or greater than 4/10 of the EVA.
- Patients with a medical certificate to the sport.
Who cannot join
- Systemic disease, whether or not, generating pain musculoskeletal
- Heart disease, respiratory, endocrine, metabolic or neurological.
- Patients and patient pregnant lactating or planning to become pregnant within 2 years.
- Patients who have changed in the last 2 months any pharmacological treatment.
- Patients taking drugs that affect the heart rate variability
- Patients who have conditions that could affect the cortisol levels
- Patients with a psychiatric diagnosis of schizophrenia, delusional disorder and other personality disorders
- Patients taking substances affecting cortisol secretion
Trial locations and contacts
2 sites in 1 country.
About this study
Fibromyalgia affects 1.4 now 2.2% of the general population whose symptom is the presence of widespread pain in all four quadrants of the body. Currently, there is no causal treatment of fibromyalgia syndrome.
The aim of this study is the evaluation of a specific training program on controls of pain in fibromyalgia patients by balancing the stress axis.
The primary endpoint is the improvement in the Visual Analogue Scale VAS difference) measured during the test of the thermode (difference between the average VAS measured between the 10th and 40th second of P1 and the average VAS measured between the 10th and 40th of the second P3) between D0 (3rd consultation) and M24 (5th consultation - end of study visit), which will be compared in the two groups..Salivary cortisol is also tested.
Read the detailed description
A specific training program under the guidance of a physiotherapist, a professor of Adapted Physical Activity (APA) and individualized whose objective is to strengthen the parasympathetic tone and modulate the reactivity of the sympathetic system and the report of the Hypothalamic-Pituitary-Adrenal (HPA) axis.This training program consists of three sessions of 45 minutes of physical activity per week for 2 years. The exercise intensity is initially very low and will be gradually increased according to your abilities and your tolerance to stress. A 6-Minute Walk Test (6MWT) will be carried out by the physiotherapist and by Professor APA, every 6 months to monitor the progression. For tracking the training program, a phone call is scheduled every week during the first 3 months, then a phone call every 15 days during the following months until the end of the study.Evaluation of neuromodulation of pain will be measured thanks to thermodeTest , experimental method implementing a tonic thermal pain using a "Peltier type Thermode" 3 cm2 model TSA II and immersion in a bath of cold water.
Participants will be randomly assigned to 2 groups, "Training" group or "Control" group.
The control group is a training program supervised by physical therapists and teachers in Adapted Physical Activity, identical to the active program in its follow-up, but the intensity of the sessions is lower.
Study schedule :
- 1st visit : screening visit at D-30
- 2nd visit : inclusion at D-7
- 3rd visit at D0
- 4st visit between M6 and M9
- 5th visit at M24
The patients included in the study will receive in addition to the training program, taking into bio-psycho-social multidisciplinary.
- Conditions
- Fibromyalgia
- Being tested
- thermode (TSA-II model), Adapted Physical Activity, Physical activity
- Keywords
- VAS, thermode test, training program, 6MWT
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thermode (TSA-II model)Device
thermal stimulation with test thermode
Adapted Physical ActivityOther
Physical activityOther
| Study group | Role | What they receive |
|---|---|---|
| training group | Experimental | The training program consists of three sessions of 45 minutes of physical activity per week for 2 years. During the first 6-9 months, two individual workouts, supervised by a physiotherapist and a session in Living.
Depending on the capacity and exercise tolerance of the patient, patients realize the second phase of training until 2 years of the study: three exercise sessions from 45 to 60 minutes per week of which group session led by a professor of Adapted Physical Activity (APA) and 2 autonomous sessions.
Thermal stimulation with test thermode Thermic stimulations (tonic heat pain stimulation and cold-pressor test) are used to test excitatory and inhibitory pain mechanisms Receives: Device: thermode (TSA-II model); Other: Adapted Physical Activity; Other: Physical activity |
| control group | Placebo comparator | A training program supervised by physical therapists and teachers in Adapted Physical Activity, identical to the active program in its follow-up, but the intensity of the sessions is lower than that of the training group Receives: Other: Adapted Physical Activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain as assessed by Visual analog scale
Measured: baseline to 24 months
Secondary outcomes (8)
salivary cortisol
three times : 3th visit at Day 0, 4th visit between month 6 and 9, 5th visit at month 24
Measured: baseline to 24 months
heart rate variability
three times : 2th visit at Day -7, 4th visit between month 6 and 9, 5th visit at month 24
Measured: baseline to 24 months
Fibromyalgia Impact Questionnaire (FIQ)
Measured: baseline to 24 months
Hospital Anxiety Depression Scale (HADS)
Measured: baseline to 24 months
Pressure Pain Threshold (PSS)
Measured: baseline to 24 months
International Physical Activity Questionnaire (IPAQ)
Measured: baseline to 24 months
Pittsburgh Sleep Quality Index (PSQI)
Measured: baseline to 24 months
Saint-Antoine Pain Questionnaire (SAPQ)
Measured: baseline to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2015 (estimated)
- Study start7 Oct 2015
- Primary completion21 Feb 2019
- Study completion21 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gildas L'HEVEDER, Doctor, Principal investigator, CHRU BREST
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02486965
- Sponsor's protocol ID
- DOUFISPORT (RB 14.076)
- Acronym
- DOUFISPORT
- Status last verified
- Apr 2022
- First submitted
- 26 Feb 2015
- Last updated
- 22 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Le Fur Bonnabesse A, Cabon M, L'Heveder G, Kermarrec A, Quinio B, Woda A, Marchand S, Dubois A, Giroux-Metges MA, Rannou F, Misery L, Bodere C. Impact of a specific training programme on the neuromodulation of pain in female patient with fibromyalgia (DouFiSport): a 24-month, controlled, randomised, double-blind protocol. BMJ Open. 2019 Jan 25;9(1):e023742. doi: 10.1136/bmjopen-2018-023742.
PubMed 30782715
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Specific Training Program on the Neuromodulation of Pain in Fibromyalgia Subjects
- ClinicalTrials.gov ID
- NCT02486965
- Acronym / sponsor ID
- DOUFISPORT / DOUFISPORT (RB 14.076)
- Conditions
- Fibromyalgia
- Keywords
- VAS, thermode test, training program, 6MWT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 7 Oct 2015 (actual)
- Primary completion
- 21 Feb 2019 (actual)
- Study completion
- 21 Oct 2021 (actual)
- First posted
- 1 Jul 2015 (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.
Fibromyalgia affects 1.4 now 2.2% of the general population whose symptom is the presence of widespread pain in all four quadrants of the body. Currently, there is no causal treatment of fibromyalgia syndrome.
The aim of this study is the evaluation of a specific training program on controls of pain in fibromyalgia patients by balancing the stress axis.
The primary endpoint is the improvement in the Visual Analogue Scale VAS difference) measured during the test of the thermode (difference between the average VAS measured between the 10th and 40th second of P1 and the average VAS measured between the 10th and 40th of the second P3) between D0 (3rd consultation) and M24 (5th consultation - end of study visit), which will be compared in the two groups..Salivary cortisol is also tested.
Detailed description
A specific training program under the guidance of a physiotherapist, a professor of Adapted Physical Activity (APA) and individualized whose objective is to strengthen the parasympathetic tone and modulate the reactivity of the sympathetic system and the report of the Hypothalamic-Pituitary-Adrenal (HPA) axis.This training program consists of three sessions of 45 minutes of physical activity per week for 2 years. The exercise intensity is initially very low and will be gradually increased according to your abilities and your tolerance to stress. A 6-Minute Walk Test (6MWT) will be carried out by the physiotherapist and by Professor APA, every 6 months to monitor the progression. For tracking the training program, a phone call is scheduled every week during the first 3 months, then a phone call every 15 days during the following months until the end of the study.Evaluation of neuromodulation of pain will be measured thanks to thermodeTest , experimental method implementing a tonic thermal pain using a "Peltier type Thermode" 3 cm2 model TSA II and immersion in a bath of cold water.
Participants will be randomly assigned to 2 groups, "Training" group or "Control" group.
The control group is a training program supervised by physical therapists and teachers in Adapted Physical Activity, identical to the active program in its follow-up, but the intensity of the sessions is lower.
Study schedule :
- 1st visit : screening visit at D-30
- 2nd visit : inclusion at D-7
- 3rd visit at D0
- 4st visit between M6 and M9
- 5th visit at M24
The patients included in the study will receive in addition to the training program, taking into bio-psycho-social multidisciplinary.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| training group | Experimental | Device: thermode (TSA-II model), Other: Adapted Physical Activity, Other: Physical activityThe training program consists of three sessions of 45 minutes of physical activity per week for 2 years. During the first 6-9 months, two individual workouts, supervised by a physiotherapist and a session in Living. Depending on the capacity and exercise tolerance of the patient, patients realize the second phase of training until 2 years of the study: three exercise sessions from 45 to 60 minutes per week of which group session led by a professor of Adapted Physical Activity (APA) and 2 autonomous sessions. Thermal stimulation with test thermode Thermic stimulations (tonic heat pain stimulation and cold-pressor test) are used to test excitatory and inhibitory pain mechanisms |
| control group | Placebo comparator | Other: Adapted Physical ActivityA training program supervised by physical therapists and teachers in Adapted Physical Activity, identical to the active program in its follow-up, but the intensity of the sessions is lower than that of the training group |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Diagnosis of fibromyalgia is clearly established by the criteria of the American College of Rheumatology (ACR).
- Body Mass Index (BMI) between 18.5 and 24.9 kg / m² (normal weight at HAS).
- Spontaneous pain intensity greater than 3/10 on a VAS. Pain triggered by palpation must be equal to or greater than 4/10 of the EVA.
- Patients with a medical certificate to the sport.
Key exclusion criteria (8 listed)
- Systemic disease, whether or not, generating pain musculoskeletal
- Heart disease, respiratory, endocrine, metabolic or neurological.
- Patients and patient pregnant lactating or planning to become pregnant within 2 years.
- Patients who have changed in the last 2 months any pharmacological treatment.
- Patients taking drugs that affect the heart rate variability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| thermode (TSA-II model)thermal stimulation with test thermode | Device | training group |
| Adapted Physical Activity | Other | control group, training group |
| Physical activity | Other | training group |
Primary outcome
Pain as assessed by Visual analog scale
Time frame: baseline to 24 months
8 secondary outcomes
salivary cortisol
Time frame: baseline to 24 months
heart rate variability
Time frame: baseline to 24 months
Fibromyalgia Impact Questionnaire (FIQ)
Time frame: baseline to 24 months
Hospital Anxiety Depression Scale (HADS)
Time frame: baseline to 24 months
Pressure Pain Threshold (PSS)
Time frame: baseline to 24 months
International Physical Activity Questionnaire (IPAQ)
Time frame: baseline to 24 months
Pittsburgh Sleep Quality Index (PSQI)
Time frame: baseline to 24 months
Saint-Antoine Pain Questionnaire (SAPQ)
Time frame: baseline to 24 months
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 22 Apr 2022.
- Derived from this study: PubMed 30782715Le Fur Bonnabesse A, Cabon M, L'Heveder G, Kermarrec A, Quinio B, Woda A, Marchand S, Dubois A, Giroux-Metges MA, Rannou F, Misery L, Bodere C. Impact of a specific training programme on the neuromodulation of pain in female patient with fibromyalgia (DouFiSport): a 24-month, controlled, randomised, double-blind protocol. BMJ Open. 2019 Jan 25;9(1):e023742. doi: 10.1136/bmjopen-2018-023742.
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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.
Gildas L'HEVEDER, Doctor principal investigator
CHRU BREST
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing thermode (TSA-II model), Adapted Physical Activity and Physical activity in people with Fibromyalgia, run by University Hospital, Brest at 2 sites in France.
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 4 inclusion and 8 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 22 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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. Some participants in this study may receive a placebo. 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?
Pain as assessed by Visual analog scale (time frame: baseline to 24 months). 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 NCT02486965, which also lists 1 linked publication.
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 22 Apr 2022.