Effects of a Motor Imagery Exercise Protocol in Patients With Fibromyalgia

Fibromyalgia Clinical Trial

Official title:

Effects of a Motor Imagery Exercise Protocol on Chronic Pain and Emotional Distress in Patients With Fibromyalgia: a Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03870932
• Other study ID #: URomLS-2018
• Status: Completed
• Phase: N/A
• Start date: July 1, 2016
• Est. completion date: August 30, 2018

Study information

• Verified date: May 2019
• Source: University of Roma La Sapienza
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: August 30, 2018
• Est. primary completion date: December 15, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Fibromyalgia
• Image, Body
• Myofascial Pain Syndromes
• Pain, Chronic
• Psychological Distress

Intervention

Other:
• Motor Imagery physical therapy

• Conventional physical therapy

Locations

Country	Name	City	State
Italy	Umberto I Hospital	Rome

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fibromyalgia Impact Questionnaire (FIQ)	self-administered instrument to assess the current health status of patients with fibromyalgia	0-4-12 weeks
Primary	Health Assessment Questionnaire (HAQ)	comprehensive measure of outcome in patients with a wide variety of chronic diseases	0-4-12 weeks
Primary	Fibromyalgia Assessment Status (FAS)	self-administered index that combines fatigue, sleep disturbances and pain in 16 non-articular sites	0-4-12 weeks
Primary	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.	0-4-12 weeks
Primary	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.	0-4-12 weeks
Primary	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.	0-4-12 weeks
Primary	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.	0-4-12 weeks
Primary	Coping Orientation to the Problems Experienced (COPE-NIV)	instrument for measuring a broad range of coping styles	0-4-12 weeks