A Comparison of the Effect of Two Types of Whole Body Vibration on Fibromyalgia. A Randomized Controlled Trial.

Fibromyalgia Clinical Trial

Official title:

A Comparison of the Effect of Two Types of Whole Body Vibration on Fibromyalgia. A Randomized Controlled Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04128813
• Other study ID #: IB 2586/15 PI-2
• Status: Recruiting
• Phase: N/A
• Start date: October 16, 2019
• Est. completion date: April 17, 2020

Study information

• Verified date: October 2019
• Source: University of the Balearic Islands
• Contact: José Antonio JA Mingorance, PhD
• Phone: +34677602465
• Email: josea.mingorance[@]uib.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to compare the effectiveness of two types of body vibration platform, one vertical and one rotational, through a 12-week training in patients with fibromyalgia.

Description:

This is a single blind randomized controlled trial. Sixty patients of FM will be assigned randomly to 3 study groups: 20 patients will be part of the vertical whole body vibration experimental group in the EG1, that will perform a neuromuscular treatment using the vertical whole body vibration platform, another 20 will constitute the rotational whole body vibration experimental group in the EG2, that will perform a neuromuscular treatment using the rotational whole body vibration platform, and another 20 will constitute the control group (CG). All these subjects will sign the corresponding informed consent for their participation in the study, according to the ethical criteria established in the Helsinki Declaration. The study will take place between January and December 2016. Three groups of variables were analyzed in the present study three times: before, after and follow-up after three months of the intervention.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: April 17, 2020
• Est. primary completion date: January 17, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

Inclusion Criteria:

-Diagnosis of fibromyalgia according with the 1990 classification criteria of the American College of Rheumatology for fibromyalgia

Exclusion Criteria:

• History of severe trauma.

• Severe disease that prevents supporting the program physical load.

• Pregnancy.

• Participation in a psychological or physical therapy program.

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Device:
• Vertical whole body vibration
A neuromuscular treatment using two types of whole body vibration platforms, a rotational and a vertical platform.

Locations

Country	Name	City	State
Spain	University of Balearic Islands	Palma de Mallorca	Balearic Islands

Sponsors (1)

Lead Sponsor	Collaborator
University of the Balearic Islands

Country where clinical trial is conducted

Spain, 

References & Publications (2)

Adsuar JC, Del Pozo-Cruz B, Parraca JA, Olivares PR, Gusi N. Whole body vibration improves the single-leg stance static balance in women with fibromyalgia: a randomized controlled trial. J Sports Med Phys Fitness. 2012 Feb;52(1):85-91. — View Citation

Sañudo B, de Hoyo M, Carrasco L, Rodríguez-Blanco C, Oliva-Pascual-Vaca A, McVeigh JG. Effect of whole-body vibration exercise on balance in women with fibromyalgia syndrome: a randomized controlled trial. J Altern Complement Med. 2012 Feb;18(2):158-64. doi: 10.1089/acm.2010.0881. Epub 2012 Feb 9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pressure Pain Thresholds	Pressure stimuli were applied on epicondyles and index finger.	20 minutes
Primary	Vibration Thresholds	Peripheral sensory function was evaluated by measuring vibration thresholds.	20 minutes
Primary	Six-minute Walking Test (6MWT)	The 6MWT is a functional test in which the patient walks what he can during 6 minutes, analyzing the total distance walked.	6 minutes.
Primary	Dynamometer	A back muscle dynamometer was used to measure isometric back muscle strength.	5 minutes.
Primary	Romberg's Balance Test Modified Version	In the present study, we analyzed the oscillatory body movements during the test performance. Participants were situated below a cam situated above the ground and regulated to be placed at a mean distance of 50 cm. from the participant's head. They were asked to remain in orthostatic position with feet parallel at shoulder height, arms extended along the body and eyes closed for 1 minute.	1 minute.
Primary	Gait Task	gait velocity (cm/sec)	5 minutes.
Primary	Fibromyalgia Impact Questionnaire (FIQ)	Fibromyalgia Impact Questionnaire (FIQ	10 minutes.
Primary	Visual Analogue Pain Scale (VAS)	Each participant was asked to indicate their current level of pain using a 20 cm VAS that ranged from 0 (no pain) to 100 (highest level of pain).	5 minutes.
Primary	Perceived Quality of Life Index	The Quality of Life Index (QLI-Sp) is a self-report questionnaire that measures perceived health-related quality of life that includes 10 items or domains: physical wellbeing, psychological/emotional well-being, selfcare and independent functioning, occupational functioning,interpersonal functioning, social-emotional support, community and services support, personal ful?lment, spiritual ful?lment, and overall quality of life.	10 minutes.