A New Rehabilitation Tool in Fibromyalgia

NCT ID: NCT02472093

Last Updated: 2015-06-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2013-05-31

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.

Conditions

Fibromyalgia; Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Physical exercises treatment

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.

Group Type: ACTIVE_COMPARATOR

Physical exercises treatment

Intervention Type: OTHER

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 Treatment

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.

Group Type: EXPERIMENTAL

Perceptive Rehabilitation Treatment

Intervention Type: OTHER

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 group

The control group did brief educational sessions.

Group Type: ACTIVE_COMPARATOR

Control group

Intervention Type: OTHER

The control group did brief educational sessions.

Interventions

Physical exercises treatment

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.

Intervention Type: OTHER

Perceptive Rehabilitation Treatment

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.

Intervention Type: OTHER

Control group

The control group did brief educational sessions.

Intervention Type: OTHER

Other Intervention Names

Rehabilitation Group Exercises; Perceptual surfaces

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• chronic respiratory disease
• kidney disease
• poor vision

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Roma La Sapienza

OTHER

Sponsor Role: lead

Responsible Party

Teresa Paolucci

medical director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Vincenzo Maria Saraceni

Role: PRINCIPAL_INVESTIGATOR

Umberto I Hospital, Sapienza University of Rome

Other Identifiers

2547-720/2012

Identifier Type: -

Identifier Source: org_study_id