FibromyalgiaNCT02472093
A New Rehabilitation Tool in Fibromyalgia
A study testing Physical exercises treatment and Perceptive Rehabilitation Treatment in people with Fibromyalgia and Pain, run by University of Roma La Sapienza.
Trial summary
The aim of the investigators study was to measure reductions in chronic pain in female patients with Fibromylgia comparing individual proprioceptive rehabilitation treatments with perceptual surfaces to a group exercises rehabilitation. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Fibromyalgia, Pain
- What is being tested?
- Physical exercises treatment and Perceptive Rehabilitation Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- No sites listed yet
- Study dates
- May 2012to May 2013
- 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
- fibromyalgia diagnosed according to the criteria proposed by the American College of Rheumatology (ACR 1990 and 2010)
- Subjects aged between 18 and 60 years
- visual analog scale (VAS) for pain > 5
Who cannot join
- presence of concomitant autoimmune diseases
- psychiatric disorders
- other causes of chronic pain
- other diseases that prevented physical loading
- severe scoliosis or kyphoscoliosis
- surgery of the spine
Show all 18Show fewer
- vertebral fractures
- sciatic pain
- tumors
- enrolled in another type of physical therapy program
- myocardial infarction
- lower extremity arterial disease
- major neurological problems
- diabetes
- gastrointestinal disease
- chronic respiratory disease
- kidney disease
- poor vision
About this study
Official title: A New Rehabilitation Tool in Fibromyalgia: Efficacy of Perceptive Rehabilitation Versus Group Exercises on Pain and Function: a Clinical Randomized Controlled Trial (RCT)
The aim of the investigators study was to measure reductions in chronic pain in female patients with Fibromylgia comparing individual proprioceptive rehabilitation treatments with perceptual surfaces to a group exercises rehabilitation. Fibromyalgia is a generalized chronic pain condition that is usually accompanied by fatigue, sleep disturbance and psychological and cognitive alterations.
- Conditions
- Fibromyalgia, Pain
- Being tested
- Physical exercises treatment, Perceptive Rehabilitation Treatment, Control group
- Keywords
- Postural exercise, Back pain, Tender points, Fibromyalgia, Perceptive rehabilitation
- Medical subject headings
- Fibromyalgia, Pain, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical exercises treatmentOther
Also called Rehabilitation Group Exercises
Includes different types of exercises: low-impact to moderate aerobic training; walking fast 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 in the supine position to improve axial stability, including diaphragmatic breathing. The heart rate was monitored through the use of a heart rate monitor, which allowed not to exceed the threshold.
Perceptive Rehabilitation TreatmentOther
Also called Perceptual surfaces
therapeutic system that is based on the interaction between the patient's back or painful area and a support surface, composed of small latex cones with various dimensions (height: 3-8 cm; base diameter: 2-4 cm) and elasticities. The inferior bases of these cones are applied to a rigid wood surface using elastic strips.
Control groupOther
The control group did brief educational sessions.
| Study group | Role | What they receive |
|---|---|---|
| Physical exercises treatment | Active comparator | The types of exercises included: low-impact to moderate aerobic training (gradually starting from 50% of the Fc max to 70%-80% of Fc max); walking fast 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 in the supine position to improve axial stability, including diaphragmatic breathing. Receives: Other: Physical exercises treatment |
| Perceptive Rehabilitation Treatment | Experimental | Perceptual surfaces is a therapeutic system that is based on the interaction between the patient's back or painful area and a support surface, composed of small latex cones with various dimensions (height: 3-8 cm; base diameter: 2-4 cm) and elasticities. The inferior bases of these cones are applied to a rigid wood surface using elastic strips; usually, over 100 cones are used for each session. Patients were asked to lie down supine on the surface that was formed by the smoothed apex of these cones, creating reaction forces to the patient's weight, generated by the interaction with the cones. Receives: Other: Perceptive Rehabilitation Treatment |
| Control group | Active comparator | The control group did brief educational sessions. Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Fibromyalgia Assessment Scale (FAS) from baseline to 12 weeks
It is a simple and rapidly implemented index, consisting of a pain map, called the Self-Assessment Pain Scale (SAPS) (in which the patient is asked to indicate how much pain he suffered in the previous week in 16 areas of the body, with scored from 0 to 3), and 2 scales (between 0 and 10) that evaluate fatigue and quality of sleep, scored from 0-10. The FAS allows physicians to obtain reliable information concerning the course of the disease and is sufficiently sensitive to alert them in case of deterioration.
Measured: baseline, 4 weeks, 12 weeks
Secondary outcomes (2)
Change of Fibromyalgia Impact Questionnaire (FIQ) from baseline to 12 weeks
It comprises 3 sections-function, impact, and symptoms-combining to generate an overall score. The first section contains 10 sub items and focuses on the patient's ability to perform daily tasks that involve the large muscles (eg, cooking, cleaning, walking, shopping, homemaking, socializing, and mobility). The next 2 items ask patients to circle the number of days in the past week in which they felt good and the number of days that they missed work. The last 7 items assess the ability to do one's job, pain, fatigue, morning tiredness, stiffness, anxiety, and depression. The total score on the FIQ is calculated by adding the following 10 items: the physical function score, the number of days feeling good, the number of work days missed, the ability to do one's job, pain, fatigue, morning tiredness, stiffness, anxiety, and depression. The FIQ score ranges from 0 to 100, with 100 indicating the worst possible score due to Fibromylgia.
Measured: baseline, 4 weeks, 12 weeks
Change of Health Assessment Questionnaire (HAQ) from baseline to 12 weeks
It is a 20-item self-administered questionnaire that determines the difficulty in performing 8 daily activities (dressing and grooming, getting up, eating, walking, hygiene, reaching, ability to grip, and outside activities). For each item, patients are asked to rate the level of difficulty that they have experienced over the previous week in performing these activities on a 4-point scale from 0 (no difficulty) to 3 (unable to perform). The final HAQ score is the average score of the 8 categories, thus ranging from 0 to 3; higher scores reflect greater levels of disability.
Measured: baseline, 4 weeks, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2015 (estimated)
- Study startMay 2012
- Primary completionJun 2012
- Study completionMay 2013
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 88 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
- Vincenzo Maria Saraceni, Principal investigator, Umberto I Hospital, Sapienza University of Rome
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02472093
- Sponsor's protocol ID
- 2547-720/2012
- Status last verified
- May 2012
- First submitted
- 6 Jun 2015
- Last updated
- 15 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Rehabilitation Tool in Fibromyalgia: Efficacy of Perceptive Rehabilitation Versus Group Exercises on Pain and Function: a Clinical Randomized Controlled Trial (RCT)
- ClinicalTrials.gov ID
- NCT02472093
- Acronym / sponsor ID
- 2547-720/2012
- Conditions
- Fibromyalgia, Pain
- Keywords
- Postural exercise, Back pain, Tender points, Fibromyalgia, Perceptive rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Jun 2012 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 15 Jun 2015 (estimated)
- 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 the investigators study was to measure reductions in chronic pain in female patients with Fibromylgia comparing individual proprioceptive rehabilitation treatments with perceptual surfaces to a group exercises rehabilitation. Fibromyalgia is a generalized chronic pain condition that is usually accompanied by fatigue, sleep disturbance and psychological and cognitive alterations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Physical exercises treatment | Active comparator | Other: Physical exercises treatmentThe types of exercises included: low-impact to moderate aerobic training (gradually starting from 50% of the Fc max to 70%-80% of Fc max); walking fast 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 in the supine position to improve axial stability, including diaphragmatic breathing. |
| Perceptive Rehabilitation Treatment | Experimental | Other: Perceptive Rehabilitation TreatmentPerceptual surfaces is a therapeutic system that is based on the interaction between the patient's back or painful area and a support surface, composed of small latex cones with various dimensions (height: 3-8 cm; base diameter: 2-4 cm) and elasticities. The inferior bases of these cones are applied to a rigid wood surface using elastic strips; usually, over 100 cones are used for each session. Patients were asked to lie down supine on the surface that was formed by the smoothed apex of these cones, creating reaction forces to the patient's weight, generated by the interaction with the cones. |
| Control group | Active comparator | Other: Control groupThe control group did brief educational sessions. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- fibromyalgia diagnosed according to the criteria proposed by the American College of Rheumatology (ACR 1990 and 2010)
- Subjects aged between 18 and 60 years
- visual analog scale (VAS) for pain > 5
Key exclusion criteria (18 listed)
- presence of concomitant autoimmune diseases
- psychiatric disorders
- other causes of chronic pain
- other diseases that prevented physical loading
- severe scoliosis or kyphoscoliosis
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 |
|---|---|---|
| Physical exercises treatmentAlso: Rehabilitation Group ExercisesIncludes different types of exercises: low-impact to moderate aerobic training; walking fast 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 in the supine position to improve axial stability, including diaphragmatic breathing. The heart rate was monitored through the use of a heart rate monitor, which allowed not to exceed the threshold. | Other | Physical exercises treatment |
| Perceptive Rehabilitation TreatmentAlso: Perceptual surfacestherapeutic system that is based on the interaction between the patient's back or painful area and a support surface, composed of small latex cones with various dimensions (height: 3-8 cm; base diameter: 2-4 cm) and elasticities. The inferior bases of these cones are applied to a rigid wood surface using elastic strips. | Other | Perceptive Rehabilitation Treatment |
| Control groupThe control group did brief educational sessions. | Other | Control group |
Primary outcome
Change of Fibromyalgia Assessment Scale (FAS) from baseline to 12 weeks
Time frame: baseline, 4 weeks, 12 weeks
It is a simple and rapidly implemented index, consisting of a pain map, called the Self-Assessment Pain Scale (SAPS) (in which the patient is asked to indicate how much pain he suffered in the previous week in 16 areas of the body, with scored from 0 to 3), and 2 scales (between 0 and 10) that evaluate fatigue and quality of sleep, scored from 0-10. The FAS allows physicians to obtain reliable information concerning the course of the disease and is sufficiently sensitive to alert them in case of deterioration.
2 secondary outcomes
Change of Fibromyalgia Impact Questionnaire (FIQ) from baseline to 12 weeks
Time frame: baseline, 4 weeks, 12 weeks
Change of Health Assessment Questionnaire (HAQ) from baseline to 12 weeks
Time frame: baseline, 4 weeks, 12 weeks
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 15 Jun 2015.
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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.
Vincenzo Maria Saraceni principal investigator
Umberto I Hospital, Sapienza University of Rome
Questions about this trial
What is this clinical trial studying?
A study testing Physical exercises treatment and Perceptive Rehabilitation Treatment in people with Fibromyalgia and Pain, run by University of Roma La Sapienza.
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 3 inclusion and 18 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 15 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Change of Fibromyalgia Assessment Scale (FAS) from baseline to 12 weeks (time frame: baseline, 4 weeks, 12 weeks). 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 15 Jun 2015.