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Repetitive Thinking in Fibromyalgia (PRFM-3)

Primary Purpose

Rumination, Fibromyalgia, Chronic Pain

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
rumination induction
distraction induction
Sponsored by
Centre Hospitalier Universitaire, Amiens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Rumination focused on measuring Rumination, Fibromyalgia, Chronic Pain, affectivity, repetitive negative thinking

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU Amiens

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Rumination group

distraction group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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."

Full Information

First Posted
May 23, 2019
Last Updated
July 17, 2020
Sponsor
Centre Hospitalier Universitaire, Amiens
Collaborators
Université de Lille
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1. Study Identification

Unique Protocol Identification Number
NCT03964285
Brief Title
Repetitive Thinking in Fibromyalgia
Acronym
PRFM-3
Official Title
Impact of Rumination on Affectivity After Physical Activity in Fibromyalgia
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
February 26, 2019 (Actual)
Primary Completion Date
February 25, 2020 (Actual)
Study Completion Date
February 25, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens
Collaborators
Université de Lille

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rumination, Fibromyalgia, Chronic Pain, Repetitive Negative Thinking
Keywords
Rumination, Fibromyalgia, Chronic Pain, affectivity, repetitive negative thinking

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rumination group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
distraction group
Arm Type
Experimental
Arm Description
Distraction will follow a relevant activity for our patients: climbing steps. Distraction induction will be done right after climbing the steps.
Intervention Type
Other
Intervention Name(s)
rumination induction
Intervention Description
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
Intervention Name(s)
distraction induction
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in PANAS score before and after induction phase
Description
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.
Time Frame
One hour and twenty minutes after inclusion of the patients
Secondary Outcome Measure Information:
Title
Change in VAS score before and after induction phase
Description
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."
Time Frame
One hour and twenty minutes after inclusion of the patients

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Serra, MD
Organizational Affiliation
CHU Amiens
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Virginie Marechal, MD
Organizational Affiliation
CHU Amiens
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alain DERVAUX, MD
Organizational Affiliation
CHU Amiens
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jérémy Fonseca Das Neves, PhD
Organizational Affiliation
CHU Amiens
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stéphane Rusinek, PHD
Organizational Affiliation
Lille University
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Amiens
City
Amiens
ZIP/Postal Code
80054
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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Repetitive Thinking in Fibromyalgia

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