search
Back to results

Effects of a Motor Imagery Exercise Protocol in Patients With Fibromyalgia

Primary Purpose

Fibromyalgia, Pain, Chronic, Image, Body

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Motor Imagery physical therapy
Conventional physical therapy
Sponsored by
University of Roma La Sapienza
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring Fibromyalgia, Pain, Imagery

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • experienced widespread pain for more than 3 months
  • pain with 4 kg/cm2 pressure at 11 or more of the 18 tender points
  • aged 18 to 60 years
  • pharmacological therapeutic regimen must have been stable for at least three months before

Exclusion Criteria:

  • pregnant women
  • pacemaker wearers
  • overlapping painful conditions
  • presence of autoimmune or hematologic diseases
  • psychiatric disorders in pharmacological and psychological treatment
  • other causes of chronic pain
  • other diseases such as epilepsy, tumors, major neurological problems and diabetes

Sites / Locations

  • Umberto I Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Motor imagery rehabilitative group (MIG)

Control rehabilitative Group (CG)

Arm Description

All patients performed 10 treatment sessions, lasting 60 to 90 minutes, twice a week, in groups of three to four patients. The gold standard was to choose simple and safe exercises in order to encourage the patient to repeat the schedule at home. The exercises proposed in the MIG have been chosen respecting the following principles: slowness, painlessness, promoting attention, easy to imagine. The main purpose of motor imagery-based exercises was to bring the patient back to "feeling and self-perceiving" the execution of the movement. More than the "quantity" of repetition, the "quality" of the movement, free from pain, was important.

The CG received a conventional rehabilitation protocol, based on ten 1-hour sessions, held twice a week (over a 5-week period), previously investigated as efficient in FM by the authors and published. The exercises included low-to-moderate impact aerobic training, walking in a circle, alternating with periods of going up and down the stairs (3 steps for 10 minutes), for a total of 20 consecutive minutes, posture exercises for the back and proprioceptive exercises for the trunk, to improve axial stability. Each exercise was repeated 10 times (3 sets of 10), with a resting period of at least 3 minutes between sets. All sessions ended with stretching and diaphragmatic breathing exercises.

Outcomes

Primary Outcome Measures

Fibromyalgia Impact Questionnaire (FIQ)
self-administered instrument to assess the current health status of patients with fibromyalgia
Health Assessment Questionnaire (HAQ)
comprehensive measure of outcome in patients with a wide variety of chronic diseases
Fibromyalgia Assessment Status (FAS)
self-administered index that combines fatigue, sleep disturbances and pain in 16 non-articular sites
Visual Analogue Scale (VAS)
Instrument to assess unidimensional measure of pain intensity. VAS was presented in a coloured scale with a middle point, graduations and numbers. Under the scale there was a straight horizontal line of fixed length, 100 mm. The ends were defined as the limits of the parameter to be measured (pain in the last 24 hours), orientated from the left (worst, no pain) to the right (best, worst pain to be imagined). The score is determined by measuring the distance (cm) on the 10 cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-10.
Hamilton Anxiety Rating Scale (HAM-A)
Instrument to assess anxiety severity. The HAM-A was one of the first rating scales developed to measure the severity of anxiety symptoms. The scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. It was administered by a clinician experienced in working with psychiatric patients.
Hamilton Depression Scale (HAM-D)
Otherwise known as Hamilton Rating Scale for Depression or HRSD-17. The patient is rated by a clinician on 21 items scored either on a 3-point or 5-point Likert-type scale. Although the form lists 21 items, the scoring is based on the first 17. It generally takes 15-20 minutes to complete the interview and score the results. Eight items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Nine are scored from 0-2. A score of 0-7 is considered to be normal while a score of 20 or higher indicates at least moderate severity.
20-Item Toronto Alexithymia Scale (TAS-20)
Instrument to assess alexithymia severity. The TAS is a 20-item instrument with 3 subscales: 1) difficulty Describing Feelings subscale, is used to measure difficulty describing emotions. 5 items; 2) difficulty Identifying Feeling subscale is used to measure difficulty identifying emotions. 7 items; 3) Externally-Oriented Thinking subscale, is used to measure the tendency of individuals to focus their attention externally. 8 items. The scale is a self-report scale that is comprised of 20 items. Items are rated using a 5-point Likert scale whereby 1 = strongly disagree and 5 = strongly agree. There are 5 items that are negatively keyed (items 4, 5, 10, 18 and 19). The total alexithymia score is the sum of responses to all 20 items, while the score for each subscale factor is the sum of the responses to that subscale. The TAS-20 uses cutoff scoring: equal to or less than 51 = non-alexithymia, equal to or greater than 61 = alexithymia. Scores of 52 to 60 = possible alexithymia.
Coping Orientation to the Problems Experienced (COPE-NIV)
instrument for measuring a broad range of coping styles

Secondary Outcome Measures

Full Information

First Posted
March 10, 2019
Last Updated
May 12, 2019
Sponsor
University of Roma La Sapienza
search

1. Study Identification

Unique Protocol Identification Number
NCT03870932
Brief Title
Effects of a Motor Imagery Exercise Protocol in Patients With Fibromyalgia
Official Title
Effects of a Motor Imagery Exercise Protocol on Chronic Pain and Emotional Distress in Patients With Fibromyalgia: a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
July 1, 2016 (Actual)
Primary Completion Date
December 15, 2017 (Actual)
Study Completion Date
August 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Roma La Sapienza

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
The aim of this study was to evaluate the efficacy of a novel approach with a motor imagery-based exercise program versus conventional rehabilitative approach in fibromyalgia syndrome (FM): reduction of pain was set as the primary outcome.
Detailed Description
Evidence about the therapeutic efficacy of exercise intervention programs in FM is still low and many authors suggested improving standardized exercise prescription for FM to achieve optimal results. In the literature, as an alternative approach, rehabilitative protocols in Group Music and Imagery seem to improve well-being and reduce anxiety in women with FM and suggest that Music and Imagery may help diminish pain intensity and depression. A rehabilitative approach should also consider the psychological and emotional aspects and, when possible, be accompanied by cognitive-behavioral therapy. The purpose of this research is to evaluate the possible efficacy of a novel approach with a motor imagery-based exercise program versus conventional rehabilitative approach in FM syndrome: the reduction of pain was set as the primary outcome as well as taking into account the patient's psychological and emotional condition. This study was designed as a double-blind, randomized, controlled trial.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia, Pain, Chronic, Image, Body, Psychological Distress
Keywords
Fibromyalgia, Pain, Imagery

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Motor imagery rehabilitative group (MIG)
Arm Type
Experimental
Arm Description
All patients performed 10 treatment sessions, lasting 60 to 90 minutes, twice a week, in groups of three to four patients. The gold standard was to choose simple and safe exercises in order to encourage the patient to repeat the schedule at home. The exercises proposed in the MIG have been chosen respecting the following principles: slowness, painlessness, promoting attention, easy to imagine. The main purpose of motor imagery-based exercises was to bring the patient back to "feeling and self-perceiving" the execution of the movement. More than the "quantity" of repetition, the "quality" of the movement, free from pain, was important.
Arm Title
Control rehabilitative Group (CG)
Arm Type
Active Comparator
Arm Description
The CG received a conventional rehabilitation protocol, based on ten 1-hour sessions, held twice a week (over a 5-week period), previously investigated as efficient in FM by the authors and published. The exercises included low-to-moderate impact aerobic training, walking in a circle, alternating with periods of going up and down the stairs (3 steps for 10 minutes), for a total of 20 consecutive minutes, posture exercises for the back and proprioceptive exercises for the trunk, to improve axial stability. Each exercise was repeated 10 times (3 sets of 10), with a resting period of at least 3 minutes between sets. All sessions ended with stretching and diaphragmatic breathing exercises.
Intervention Type
Other
Intervention Name(s)
Motor Imagery physical therapy
Intervention Type
Other
Intervention Name(s)
Conventional physical therapy
Primary Outcome Measure Information:
Title
Fibromyalgia Impact Questionnaire (FIQ)
Description
self-administered instrument to assess the current health status of patients with fibromyalgia
Time Frame
0-4-12 weeks
Title
Health Assessment Questionnaire (HAQ)
Description
comprehensive measure of outcome in patients with a wide variety of chronic diseases
Time Frame
0-4-12 weeks
Title
Fibromyalgia Assessment Status (FAS)
Description
self-administered index that combines fatigue, sleep disturbances and pain in 16 non-articular sites
Time Frame
0-4-12 weeks
Title
Visual Analogue Scale (VAS)
Description
Instrument to assess unidimensional measure of pain intensity. VAS was presented in a coloured scale with a middle point, graduations and numbers. Under the scale there was a straight horizontal line of fixed length, 100 mm. The ends were defined as the limits of the parameter to be measured (pain in the last 24 hours), orientated from the left (worst, no pain) to the right (best, worst pain to be imagined). The score is determined by measuring the distance (cm) on the 10 cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-10.
Time Frame
0-4-12 weeks
Title
Hamilton Anxiety Rating Scale (HAM-A)
Description
Instrument to assess anxiety severity. The HAM-A was one of the first rating scales developed to measure the severity of anxiety symptoms. The scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. It was administered by a clinician experienced in working with psychiatric patients.
Time Frame
0-4-12 weeks
Title
Hamilton Depression Scale (HAM-D)
Description
Otherwise known as Hamilton Rating Scale for Depression or HRSD-17. The patient is rated by a clinician on 21 items scored either on a 3-point or 5-point Likert-type scale. Although the form lists 21 items, the scoring is based on the first 17. It generally takes 15-20 minutes to complete the interview and score the results. Eight items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Nine are scored from 0-2. A score of 0-7 is considered to be normal while a score of 20 or higher indicates at least moderate severity.
Time Frame
0-4-12 weeks
Title
20-Item Toronto Alexithymia Scale (TAS-20)
Description
Instrument to assess alexithymia severity. The TAS is a 20-item instrument with 3 subscales: 1) difficulty Describing Feelings subscale, is used to measure difficulty describing emotions. 5 items; 2) difficulty Identifying Feeling subscale is used to measure difficulty identifying emotions. 7 items; 3) Externally-Oriented Thinking subscale, is used to measure the tendency of individuals to focus their attention externally. 8 items. The scale is a self-report scale that is comprised of 20 items. Items are rated using a 5-point Likert scale whereby 1 = strongly disagree and 5 = strongly agree. There are 5 items that are negatively keyed (items 4, 5, 10, 18 and 19). The total alexithymia score is the sum of responses to all 20 items, while the score for each subscale factor is the sum of the responses to that subscale. The TAS-20 uses cutoff scoring: equal to or less than 51 = non-alexithymia, equal to or greater than 61 = alexithymia. Scores of 52 to 60 = possible alexithymia.
Time Frame
0-4-12 weeks
Title
Coping Orientation to the Problems Experienced (COPE-NIV)
Description
instrument for measuring a broad range of coping styles
Time Frame
0-4-12 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: experienced widespread pain for more than 3 months pain with 4 kg/cm2 pressure at 11 or more of the 18 tender points aged 18 to 60 years pharmacological therapeutic regimen must have been stable for at least three months before Exclusion Criteria: pregnant women pacemaker wearers overlapping painful conditions presence of autoimmune or hematologic diseases psychiatric disorders in pharmacological and psychological treatment other causes of chronic pain other diseases such as epilepsy, tumors, major neurological problems and diabetes
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Teresa Paolucci, MD, PhD
Organizational Affiliation
Università "Sapienza" Roma
Official's Role
Principal Investigator
Facility Information:
Facility Name
Umberto I Hospital
City
Rome
ZIP/Postal Code
00165
Country
Italy

12. IPD Sharing Statement

Learn more about this trial

Effects of a Motor Imagery Exercise Protocol in Patients With Fibromyalgia

We'll reach out to this number within 24 hrs