FibromyalgiaNCT03870932
Effects of a Motor Imagery Exercise Protocol in Patients With Fibromyalgia
A study testing Motor Imagery physical therapy and Conventional physical therapy in people with Fibromyalgia and Pain, Chronic, run by University of Roma La Sapienza at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Fibromyalgia, Pain, Chronic, Image, Body
- What is being tested?
- Motor Imagery physical therapy and Conventional physical therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jul 2016to 30 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a Motor Imagery Exercise Protocol on Chronic Pain and Emotional Distress in Patients With Fibromyalgia: a Pilot Study
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.
Read the 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
- Being tested
- Motor Imagery physical therapy, Conventional physical therapy
- Keywords
- Fibromyalgia, Pain, Imagery
- Medical subject headings
- Fibromyalgia, Chronic Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motor Imagery physical therapyOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Conventional physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fibromyalgia Impact Questionnaire (FIQ)
self-administered instrument to assess the current health status of patients with fibromyalgia
Measured: 0-4-12 weeks
Health Assessment Questionnaire (HAQ)
comprehensive measure of outcome in patients with a wide variety of chronic diseases
Measured: 0-4-12 weeks
Fibromyalgia Assessment Status (FAS)
self-administered index that combines fatigue, sleep disturbances and pain in 16 non-articular sites
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 0-4-12 weeks
Coping Orientation to the Problems Experienced (COPE-NIV)
instrument for measuring a broad range of coping styles
Measured: 0-4-12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2019
- Study start1 Jul 2016
- Primary completion15 Dec 2017
- Study completion30 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Teresa Paolucci, University of Roma La Sapienza
- Investigators
- Teresa Paolucci, MD, PhD, Principal investigator, Università "Sapienza" Roma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03870932
- Sponsor's protocol ID
- URomLS-2018
- Status last verified
- May 2019
- First submitted
- 10 Mar 2019
- Last updated
- 14 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Motor Imagery Exercise Protocol on Chronic Pain and Emotional Distress in Patients With Fibromyalgia: a Pilot Study
- ClinicalTrials.gov ID
- NCT03870932
- Acronym / sponsor ID
- URomLS-2018
- Conditions
- Fibromyalgia, Pain, Chronic, Image, Body, Psychological Distress
- Keywords
- Fibromyalgia, Pain, Imagery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 15 Dec 2017 (actual)
- Study completion
- 30 Aug 2018 (actual)
- First posted
- 12 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motor imagery rehabilitative group (MIG) | Experimental | Other: Motor Imagery physical therapyAll 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. |
| Control rehabilitative Group (CG) | Active comparator | Other: Conventional physical therapyThe 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- pregnant women
- pacemaker wearers
- overlapping painful conditions
- presence of autoimmune or hematologic diseases
- psychiatric disorders in pharmacological and psychological treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motor Imagery physical therapy | Other | Motor imagery rehabilitative group (MIG) |
| Conventional physical therapy | Other | Control rehabilitative Group (CG) |
Primary outcome
Fibromyalgia Impact Questionnaire (FIQ)
Time frame: 0-4-12 weeks
self-administered instrument to assess the current health status of patients with fibromyalgia
Health Assessment Questionnaire (HAQ)
Time frame: 0-4-12 weeks
comprehensive measure of outcome in patients with a wide variety of chronic diseases
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
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.
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.
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.
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.
Coping Orientation to the Problems Experienced (COPE-NIV)
Time frame: 0-4-12 weeks
instrument for measuring a broad range of coping styles
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Teresa Paolucci, MD, PhD principal investigator
Università "Sapienza" Roma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motor Imagery physical therapy and Conventional physical therapy in people with Fibromyalgia and Pain, Chronic, run by University of Roma La Sapienza at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fibromyalgia Impact Questionnaire (FIQ) (time frame: 0-4-12 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2019.