Effects of a Motor Imagery Exercise Protocol in Patients With Fibromyalgia

Not Applicable

Completed

• Conditions: Psychological Distress; Image, Body; Fibromyalgia; Pain, Chronic

• Registration Number: NCT03870932
• Lead Sponsor: University of Roma La Sapienza

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.

Study Timeline

• Study Start: 2016-07-01
• Primary Completion: 2017-12-15
• Study Completion: 2018-08-30
• Study First Submitted: 2019-03-10
• Study First Submitted QC: 2019-03-10
• Study First Posted: 2019-03-12
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-12
• Last Update Posted: 2019-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 29

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Fibromyalgia Impact Questionnaire (FIQ)	0-4-12 weeks	self-administered instrument to assess the current health status of patients with fibromyalgia
Fibromyalgia Assessment Status (FAS)	0-4-12 weeks	self-administered index that combines fatigue, sleep disturbances and pain in 16 non-articular sites
Visual Analogue Scale (VAS)	0-4-12 weeks	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)	0-4-12 weeks	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.
Health Assessment Questionnaire (HAQ)	0-4-12 weeks	comprehensive measure of outcome in patients with a wide variety of chronic diseases
Hamilton Depression Scale (HAM-D)	0-4-12 weeks	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)	0-4-12 weeks	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)	0-4-12 weeks	instrument for measuring a broad range of coping styles

Trial Locations

Locations (1)

Umberto I Hospital; 🇮🇹 Rome, Italy