A New Rehabilitation Tool in Fibromyalgia
1 other identifier
interventional
88
0 countries
N/A
Brief 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. Fibromyalgia is a generalized chronic pain condition that is usually accompanied by fatigue, sleep disturbance and psychological and cognitive alterations.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2012
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedFirst Submitted
Initial submission to the registry
June 6, 2015
CompletedFirst Posted
Study publicly available on registry
June 15, 2015
CompletedJune 15, 2015
May 1, 2012
1 month
June 6, 2015
June 10, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
baseline, 4 weeks, 12 weeks
Secondary Outcomes (2)
Change of Fibromyalgia Impact Questionnaire (FIQ) from baseline to 12 weeks
baseline, 4 weeks, 12 weeks
Change of Health Assessment Questionnaire (HAQ) from baseline to 12 weeks
baseline, 4 weeks, 12 weeks
Study Arms (3)
Physical exercises treatment
ACTIVE COMPARATORThe 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
EXPERIMENTALPerceptual 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 COMPARATORThe control group did brief educational sessions.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- 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
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Vincenzo Maria Saraceni
Umberto I Hospital, Sapienza University of Rome
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- medical director
Study Record Dates
First Submitted
June 6, 2015
First Posted
June 15, 2015
Study Start
May 1, 2012
Primary Completion
June 1, 2012
Study Completion
May 1, 2013
Last Updated
June 15, 2015
Record last verified: 2012-05