Repetitive Thinking in Fibromyalgia

NCT ID: NCT03964285

Last Updated: 2025-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-26

Study Completion Date

2020-02-25

Brief Summary

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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

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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

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Rumination Fibromyalgia Chronic Pain Repetitive Negative Thinking

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Rumination group

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.

Group Type ACTIVE_COMPARATOR

rumination induction

Intervention Type OTHER

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 group

Distraction will follow a relevant activity for our patients: climbing steps. Distraction induction will be done right after climbing the steps.

Group Type EXPERIMENTAL

distraction induction

Intervention Type OTHER

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.

Interventions

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rumination induction

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.

Intervention Type OTHER

distraction induction

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* minor patients
* Adult major under administrative protection
* Patient with severe psychosis or depression or severe anxiety or impulsivity as assessed by the clinician
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Université de Lille

OTHER

Sponsor Role collaborator

Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eric Serra, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Amiens

Virginie Marechal, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Amiens

Alain DERVAUX, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Amiens

Jérémy Fonseca Das Neves, PhD

Role: PRINCIPAL_INVESTIGATOR

CHU Amiens

Stéphane Rusinek, PHD

Role: PRINCIPAL_INVESTIGATOR

Lille University

Locations

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CHU Amiens

Amiens, , France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 37993555 (View on PubMed)

Other Identifiers

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PI2018_843_0035

Identifier Type: -

Identifier Source: org_study_id

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