Clinical trial NCT03870932: 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
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Pain, Chronic
Image, Body
Psychological Distress
Keywords: Fibromyalgia
Pain
Imagery
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2019-03-12
Enrollment: 29
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Fibromyalgia Impact Questionnaire (FIQ)
timeFrame: 0-4-12 weeks
measure: Health Assessment Questionnaire (HAQ)
timeFrame: 0-4-12 weeks
measure: Fibromyalgia Assessment Status (FAS)
timeFrame: 0-4-12 weeks
measure: Visual Analogue Scale (VAS)
timeFrame: 0-4-12 weeks
measure: Hamilton Anxiety Rating Scale (HAM-A)
timeFrame: 0-4-12 weeks
measure: Hamilton Depression Scale (HAM-D)
timeFrame: 0-4-12 weeks
measure: 20-Item Toronto Alexithymia Scale (TAS-20)
timeFrame: 0-4-12 weeks
measure: Coping Orientation to the Problems Experienced (COPE-NIV)
timeFrame: 0-4-12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Umberto I Hospital
Study officials:
affiliation: Università "Sapienza" Roma
name: Teresa Paolucci, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: