A New Rehabilitation Tool in Fibromyalgia

University of Roma La Sapienza

Status: Completed

Conditions: Fibromyalgia; Pain

Treatments: Other: Physical exercises treatment; Other: Control group; Other: Perceptive Rehabilitation Treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT02472093

2547-720/2012

Details and patient eligibility

About

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.

Enrollment: 88 patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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88 participants in 3 patient groups

Physical exercises treatment

Active Comparator group

Description:

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.

Treatment:

Other: Physical exercises treatment

Perceptive Rehabilitation Treatment

Experimental group

Description:

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.

Treatment:

Other: Perceptive Rehabilitation Treatment

Control group

Active Comparator group

Description:

The control group did brief educational sessions.

Treatment:

Other: Control group