Repetitive Thinking in Fibromyalgia

NCT03964285 | Completed

• 1 other identifier: PI2018_843_0035
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Rumination; Fibromyalgia; Chronic Pain; Repetitive Negative Thinking

Keywords

Rumination; Fibromyalgia; Chronic Pain; affectivity; repetitive negative thinking

Outcome Measures

Primary Outcomes (1)

• 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.

  One hour and twenty minutes after inclusion of the patients

Secondary Outcomes (1)

• Change in VAS score before and after induction phase

  One hour and twenty minutes after inclusion of the patients

Study Arms (2)

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.

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.

Other: distraction induction

Interventions

rumination induction 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.

Rumination group

distraction induction 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.

distraction group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead
• Université de Lille: collaborator

Study Sites (1)

CHU Amiens

Amiens, 80054, France

Location

Related Publications (1)

• 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.

  PMID: 37993555 BACKGROUND

MeSH Terms

Conditions

Rumination Syndrome; Fibromyalgia; Chronic Pain

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Feeding and Eating Disorders; Mental Disorders; Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Eric Serra, MD

  CHU Amiens

  PRINCIPAL INVESTIGATOR

• Virginie Marechal, MD

  CHU Amiens

  PRINCIPAL INVESTIGATOR

• Alain DERVAUX, MD

  CHU Amiens

  PRINCIPAL INVESTIGATOR

• Jérémy Fonseca Das Neves, PhD

  CHU Amiens

  PRINCIPAL INVESTIGATOR

• Stéphane Rusinek, PHD

  Lille University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2019
• First Posted: May 28, 2019
• Study Start: February 26, 2019
• Primary Completion: February 25, 2020
• Study Completion: February 25, 2020
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)