Effects of a Motor Imagery Exercise Protocol in Patients With Fibromyalgia

NCT03870932 | Completed

• 1 other identifier: URomLS-2018
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia; Pain, Chronic; Image, Body; Psychological Distress

Keywords

Fibromyalgia; Pain; Imagery

Outcome Measures

Primary Outcomes (8)

• Fibromyalgia Impact Questionnaire (FIQ)

  self-administered instrument to assess the current health status of patients with fibromyalgia

  0-4-12 weeks

• Health Assessment Questionnaire (HAQ)

  comprehensive measure of outcome in patients with a wide variety of chronic diseases

  0-4-12 weeks

• Fibromyalgia Assessment Status (FAS)

  self-administered index that combines fatigue, sleep disturbances and pain in 16 non-articular sites

  0-4-12 weeks

• 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

• 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

• 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

• 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

• Coping Orientation to the Problems Experienced (COPE-NIV)

  instrument for measuring a broad range of coping styles

  0-4-12 weeks

Study Arms (2)

Motor imagery rehabilitative group (MIG)

EXPERIMENTAL

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.

Other: Motor Imagery physical therapy

Control rehabilitative Group (CG)

ACTIVE COMPARATOR

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.

Other: Conventional physical therapy

Interventions

Motor Imagery physical therapy OTHER

Motor imagery rehabilitative group (MIG)

Conventional physical therapy OTHER

Control rehabilitative Group (CG)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (1)

Umberto I Hospital

Rome, 00165, Italy

Location

MeSH Terms

Conditions

Fibromyalgia; Chronic Pain; Pain

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Teresa Paolucci, MD, PhD

  Università "Sapienza" Roma

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Medical Director (Physiatrist)

Study Record Dates

• First Submitted: March 10, 2019
• First Posted: March 12, 2019
• Study Start: July 1, 2016
• Primary Completion: December 15, 2017
• Study Completion: August 30, 2018
• Last Updated: May 14, 2019

Record last verified: 2019-05

Locations

IT (1)