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Completed

NCT Number: NCT03870932

Effects of a Motor Imagery Exercise Protocol in Patients With Fibromyalgia

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.

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Key information

Conditions

Fibromyalgia Chronic Pain Image, Body Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pain, Chronic Pathological Conditions, Signs and Symptoms Psychological Distress Rheumatic Diseases Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Umberto I Hospital

Rome, 00165, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Motor Imagery physical therapy

Other

Conventional physical therapy

Other

Primary outcomes

  1. Fibromyalgia Impact Questionnaire (FIQ)

    Time frame: 0-4-12 weeks

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

  2. Health Assessment Questionnaire (HAQ)

    Time frame: 0-4-12 weeks

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

  3. Fibromyalgia Assessment Status (FAS)

    Time frame: 0-4-12 weeks

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

  4. Visual Analogue Scale (VAS)

    Time frame: 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.

  5. Hamilton Anxiety Rating Scale (HAM-A)

    Time frame: 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.

  6. Hamilton Depression Scale (HAM-D)

    Time frame: 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.

  7. 20-Item Toronto Alexithymia Scale (TAS-20)

    Time frame: 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.

  8. Coping Orientation to the Problems Experienced (COPE-NIV)

    Time frame: 0-4-12 weeks

    instrument for measuring a broad range of coping styles

Sponsors and collaborators

Lead sponsor

University of Roma La Sapienza

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Mar 12, 2019
Registry last updated
May 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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