Effects of a Motor Imagery Exercise Protocol in Patients With Fibromyalgia

NCT ID: NCT03870932

Last Updated: 2019-05-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-01
• Study Completion Date: 2018-08-30

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Motor imagery rehabilitative group (MIG)

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.

Group Type: EXPERIMENTAL

Motor Imagery physical therapy

Intervention Type: OTHER

Control rehabilitative Group (CG)

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.

Group Type: ACTIVE_COMPARATOR

Conventional physical therapy

Intervention Type: OTHER

Interventions

Motor Imagery physical therapy

Intervention Type: OTHER

Conventional physical therapy

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Roma La Sapienza

OTHER

Sponsor Role: lead

Responsible Party

Teresa Paolucci

Assistant Medical Director (Physiatrist)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Teresa Paolucci, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Università "Sapienza" Roma

Locations

Umberto I Hospital

Rome, , Italy

Countries

Italy

Other Identifiers

URomLS-2018

Identifier Type: -

Identifier Source: org_study_id