RuminationPRFM-3NCT03964285
Repetitive Thinking in Fibromyalgia
A study testing rumination induction and distraction induction in people with Rumination and Fibromyalgia, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
Some fibromyalgia patients may use inappropriate emotional regulation strategies to respond to pain. Rumination could be one of this inefficient regulation strategies. The investigators believe that the use of rumination strategies to respond to the discomfort of daily physical activity would maintain and aggravate a… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rumination, Fibromyalgia, Chronic Pain
- What is being tested?
- rumination induction and distraction induction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteFrance
- Study dates
- 26 Feb 2019to 25 Feb 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults Patients
- Free and informed consent signed.
- French native speaker, writer and reader.
- according 1990 American College of Rheumatology criteria : Patients with diffuse pain for more than three months and with digital palpation pain on more than 11 insertion points.
Who cannot join
- minor patients
- Adult major under administrative protection
- Patient with severe psychosis or depression or severe anxiety or impulsivity as assessed by the clinician
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Rumination on Affectivity After Physical Activity in Fibromyalgia
Some fibromyalgia patients may use inappropriate emotional regulation strategies to respond to pain. Rumination could be one of this inefficient regulation strategies. The investigators believe that the use of rumination strategies to respond to the discomfort of daily physical activity would maintain and aggravate a negative emotional state after the effort. Distraction would be a more effective strategy to cope with pain. From this data, the investigators want to explore the causal link between rumination and negative affectivity after physical activity in fibromyalgia using an experimental design.
Read the detailed description
Fibromyalgia is a disorder characterized by widespread musculoskeletal pain accompanied by fatigue, sleep, memory and mood issues. As with any condition of chronic pain, psychological mechanisms can help maintain discomfort and pain. These mechanisms may hinder the recovery of physical activity. Some patients may use cognitive strategies of emotional regulation that are ineffective to cope with pain and discomfort of everyday activities, such as rumination. The literature suggests that this process is linked to the physical and psychological difficulties of fibromyalgia. However, no study has revealed a causal link between rumination and negative affectivity in a context of physical activity in this population. The investigators want to test this hypothesis by directly manipulating the style of information processing following a relevant activity for these patients: climbing steps. In one group the investigators will induce rumination right after climbing the steps. In the other group the investigators will induce distraction. Patient with Fibromyalgia will be recruited at the Pain Center of CHU-Amiens. Patients will complete different scales before to climb steps and after experimental induction. The investigators hypothesize that Patients using a rumination strategy after an uncomfortable physical activity will experience a greater subjective discomfort than patients using a distraction strategy.
- Conditions
- Rumination, Fibromyalgia, Chronic Pain, Repetitive Negative Thinking
- Being tested
- rumination induction, distraction induction
- Keywords
- Rumination, Fibromyalgia, Chronic Pain, affectivity, repetitive negative thinking
- Medical subject headings
- Rumination Syndrome, Fibromyalgia, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rumination inductionOther
The induction method is based on specific instructions given to participants on how to focus on different elements of their experience. For example, they will be led, in the rumination condition, to reflect on the causes, meanings and consequences of the amount of tension they feel in their muscles.
distraction inductionOther
The induction method is based on specific instructions given to participants on how to focus on different elements of their experience. In the distraction condition they will, for example, imagine a ship crossing the Atlantic.
| Study group | Role | What they receive |
|---|---|---|
| Rumination group | Active comparator | The patients will receive rumination induction. Rumination induction will follow a relevant activity for our patients: climbing steps. Rumination induction will be done right after climbing the steps. Receives: Other: rumination induction |
| distraction group | Experimental | Distraction will follow a relevant activity for our patients: climbing steps. Distraction induction will be done right after climbing the steps. Receives: Other: distraction induction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in PANAS score before and after induction phase
The PANAS Scale or Positive and Negative Affect Schedule (PANAS) is a self-report questionnaire. The list is split up into two segments, or mood scales. One scale measures a person's positive emotion and the other scale measures the negative. Each segment has ten terms, which can be rated on a scale of 1 to 5 to indicate the extent to which the respondent agrees that this applies to him.Characteristic of this test is the fact that it can be completed in 10 minutes. High score is associated with stress and anxiety. small score is associated with calm.
Measured: One hour and twenty minutes after inclusion of the patients
Secondary outcomes (1)
Change in VAS score before and after induction phase
The pain VAS is a unidimensional measure of pain intensity, which has been widely used in diverse adult populations, including those with rheumatic diseases. Visual analogue scales (VAS) are 10-cm lines anchored at the ends by words that define the bounds of various pain dimensions. The patient is asked to place a vertical mark on the scale to indicate the level of intensity of his or her pain, anxiety, depression, etc. 0 would mean "no pain" and 10 would mean "worst possible pain."
Measured: One hour and twenty minutes after inclusion of the patients
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2019
- Study start26 Feb 2019
- Primary completion25 Feb 2020
- Study completion25 Feb 2020
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 RuminationStudies 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
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Collaborators
- Université de Lille
- Responsible party
- Sponsor
- Investigators
- Eric Serra, MD, Principal investigator, CHU AmiensVirginie Marechal, MD, Principal investigator, CHU AmiensAlain DERVAUX, MD, Principal investigator, CHU AmiensJérémy Fonseca Das Neves, PhD, Principal investigator, CHU AmiensStéphane Rusinek, PHD, Principal investigator, Lille University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03964285
- Sponsor's protocol ID
- PI2018_843_0035
- Acronym
- PRFM-3
- Status last verified
- Sep 2025
- First submitted
- 23 May 2019
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fonseca das Neves J, Kornacka M, Serra E, Rollin N, Kosinski T, Marechal V, Jehel L, Rusinek S. The impact of rumination on fibromyalgia pain after physical activity: an experimental study. Sci Rep. 2023 Nov 22;13(1):20523. doi: 10.1038/s41598-023-47414-z.
PubMed 37993555
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Rumination on Affectivity After Physical Activity in Fibromyalgia
- ClinicalTrials.gov ID
- NCT03964285
- Acronym / sponsor ID
- PRFM-3 / PI2018_843_0035
- Conditions
- Rumination, Fibromyalgia, Chronic Pain, Repetitive Negative Thinking
- Keywords
- Rumination, Fibromyalgia, Chronic Pain, affectivity, repetitive negative thinking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Collaborators
- Université de Lille
- Study start
- 26 Feb 2019 (actual)
- Primary completion
- 25 Feb 2020 (actual)
- Study completion
- 25 Feb 2020 (actual)
- First posted
- 28 May 2019 (actual)
- 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.
Some fibromyalgia patients may use inappropriate emotional regulation strategies to respond to pain. Rumination could be one of this inefficient regulation strategies. The investigators believe that the use of rumination strategies to respond to the discomfort of daily physical activity would maintain and aggravate a negative emotional state after the effort. Distraction would be a more effective strategy to cope with pain. From this data, the investigators want to explore the causal link between rumination and negative affectivity after physical activity in fibromyalgia using an experimental design.
Detailed description
Fibromyalgia is a disorder characterized by widespread musculoskeletal pain accompanied by fatigue, sleep, memory and mood issues. As with any condition of chronic pain, psychological mechanisms can help maintain discomfort and pain. These mechanisms may hinder the recovery of physical activity. Some patients may use cognitive strategies of emotional regulation that are ineffective to cope with pain and discomfort of everyday activities, such as rumination. The literature suggests that this process is linked to the physical and psychological difficulties of fibromyalgia. However, no study has revealed a causal link between rumination and negative affectivity in a context of physical activity in this population. The investigators want to test this hypothesis by directly manipulating the style of information processing following a relevant activity for these patients: climbing steps. In one group the investigators will induce rumination right after climbing the steps. In the other group the investigators will induce distraction. Patient with Fibromyalgia will be recruited at the Pain Center of CHU-Amiens. Patients will complete different scales before to climb steps and after experimental induction. The investigators hypothesize that Patients using a rumination strategy after an uncomfortable physical activity will experience a greater subjective discomfort than patients using a distraction strategy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rumination group | Active comparator | Other: rumination inductionThe patients will receive rumination induction. Rumination induction will follow a relevant activity for our patients: climbing steps. Rumination induction will be done right after climbing the steps. |
| distraction group | Experimental | Other: distraction inductionDistraction will follow a relevant activity for our patients: climbing steps. Distraction induction will be done right after climbing the steps. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults Patients
- Free and informed consent signed.
- French native speaker, writer and reader.
- according 1990 American College of Rheumatology criteria : Patients with diffuse pain for more than three months and with digital palpation pain on more than 11 insertion points.
Key exclusion criteria (3 listed)
- minor patients
- Adult major under administrative protection
- Patient with severe psychosis or depression or severe anxiety or impulsivity as assessed by the clinician
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 |
|---|---|---|
| rumination inductionThe induction method is based on specific instructions given to participants on how to focus on different elements of their experience. For example, they will be led, in the rumination condition, to reflect on the causes, meanings and consequences of the amount of tension they feel in their muscles. | Other | Rumination group |
| distraction inductionThe induction method is based on specific instructions given to participants on how to focus on different elements of their experience. In the distraction condition they will, for example, imagine a ship crossing the Atlantic. | Other | distraction group |
Primary outcome
Change in PANAS score before and after induction phase
Time frame: One hour and twenty minutes after inclusion of the patients
The PANAS Scale or Positive and Negative Affect Schedule (PANAS) is a self-report questionnaire. The list is split up into two segments, or mood scales. One scale measures a person's positive emotion and the other scale measures the negative. Each segment has ten terms, which can be rated on a scale of 1 to 5 to indicate the extent to which the respondent agrees that this applies to him.Characteristic of this test is the fact that it can be completed in 10 minutes. High score is associated with stress and anxiety. small score is associated with calm.
1 secondary outcome
Change in VAS score before and after induction phase
Time frame: One hour and twenty minutes after inclusion of the patients
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 19 Sep 2025.
- Background: PubMed 37993555Fonseca das Neves J, Kornacka M, Serra E, Rollin N, Kosinski T, Marechal V, Jehel L, Rusinek S. The impact of rumination on fibromyalgia pain after physical activity: an experimental study. Sci Rep. 2023 Nov 22;13(1):20523. doi: 10.1038/s41598-023-47414-z.
- Individual participant dataSharing planned: No
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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.
Eric Serra, MD principal investigator
CHU Amiens
Virginie Marechal, MD principal investigator
CHU Amiens
Alain DERVAUX, MD principal investigator
CHU Amiens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rumination induction and distraction induction in people with Rumination and Fibromyalgia, run by Centre Hospitalier Universitaire, Amiens at 1 site 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 3 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 19 Sep 2025. 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 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. 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?
Change in PANAS score before and after induction phase (time frame: One hour and twenty minutes after inclusion of the patients). 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 NCT03964285, 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 19 Sep 2025.