Effectiveness of Qigong vs. Physiotherapy to Improve Quality of Life of Women With Fibromyalgia

Fibromyalgia Clinical Trial

Official title:

Effectiveness of Qigong vs. Physiotherapy to Improve Quality of Life of Women With Fibromyalgia: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04328142
• Other study ID #: 11//2012
• Status: Completed
• Phase: N/A
• Start date: March 1, 2012
• Est. completion date: September 30, 2013

Study information

• Verified date: April 2020
• Source: University of Extremadura
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study analyze the effectiveness of a Physiotherapy treatment versus a Qigong exercise programme improving quality of life of subjects with Fibromyalgia.

Description:

Objective:

This study investigated the effectiveness of a Physiotherapy treatment versus a Qigong exercise programme for the improvement of the quality of life of subjects with Fibromyalgia.

Design:

A single-blind randomized clinical controlled trial.

Setting:

University of Extremadura, Spain

Subjects:

Women with Fibromyalgia

Interventions:

141 Participants were randomized to a Qigong exercise program group (n=47), a physiotherapy treatment group (n=47) and control group (n=47) for 6 weeks.

Main Measures:

Measures were taken at baseline (week 0), pre intervention (week 1) and post intervention (week 6). The primary outcome measure were quality of life (Spanish Fibromyalgia Impact Questionnaire (SFIQ), pain (VAS), perceive exertion (Borg scale), spirometry measures (Spirobank-G MIR spirometry) and balance (Wii-Fit, Nintendo ©). The secondary outcome measures were flexibility (Wells and Dillon test and Sit and Reach test), Range of movement (goniometer), muscle strength (Lowett scale).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 165
• Est. completion date: September 30, 2013
• Est. primary completion date: September 30, 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 65 Years

Eligibility

Inclusion Criteria:

• women between 30 and 65 years old,

• diagnosed with Fibromyalgia by a specialized physician,

Exclusion Criteria:

• The exclusion criteria were to present any limitation of mobility due to Fibromyalgia or other pathology, previous practice or knowledge of Qi gong, to be under Physiotherapy treatment and to practice any physical exercise.

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Other:
• Qigong group
Traditional Chinese Medicine exercise programme
• Physiotherapy
Physiotherapy exercise programme

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Extremadura

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from the Spanish Fibromyalgia Impact Questionnaire (SFIQ) at post intervention (week 6)	SFIQ measures the level of quality of life of subjects with Fibromyalgia with a score of 0 to 100. A higher score indicates more impact of the condition on the life of the person and therefore less quality of life.	Baseline (week 0), pre intervention (week 1) and post intervention (week 6).
Primary	Change from Visual Analogue Scale (VAS) at post intervention (week 6)	The Visual analogue scale measures the level of pain with a score of 0 to 10 where 0 indicates no pain and 10 indicates maximun pain.	Baseline (week 0), pre intervention (week 1) and post intervention (week 6).
Primary	Change from Borg Scale of perceived exertion at post intervention (week 6)	Borg scale measures the perceived exertion of a subject with a score of 0 to 10 where 0 is the minimum exertion and 10 is the maximun exertion.	Baseline (week 0), pre intervention (week 1) and post intervention (week 6).
Primary	Changes from the values registered by the Spirobank-G (MIR)® spirometer	Spirometry measures respiratory values being the reference values (Knudson model) for a 50 year old woman with 1,65 cm of height and 65 kilos weight: FVC (Forced vital capacity)= 3.611, FEV1 (Forced expiratory volume) = 2.7505, FEV1%= 76.17%, FEF (Forced expiratory flow) 25-75%= 2.625, PEF (peak expiratory flow)= 6.222	Baseline (week 0), pre intervention (week 1) and post intervention (week 6).
Primary	Change from the centre of gravity registered with Wii-fit Nintendo®	Static balance and postural control is the ability to maintain the centre of gravity within the base of support. Centre of gravity is measured in percentage through posturography study. A higher percentage means better balance	Baseline (week 0), pre intervention (week 1) and post intervention (week 6).
Primary	Change from the monopodal stance test registered with Wii-fit Nintendo®	Monopodal stance test measures static balance in percentage through posturography study. It is measure in percentage from 0 to 100 and a higher percentage means a better result.	Baseline (week 0), pre intervention (week 1) and post intervention (week 6).
Secondary	Change from range of movement measured with goniometer	Shoulder and hip range of movement	Baseline (week 0), pre intervention (week 1) and post intervention (week 6).
Secondary	Change from muscle strength measured with Lovett scale	Shoulder and hip range of movement.Lovett scale is a modification of Daniels and Worthingham. The scale is measured from 0 to 5 where 0 means no muscle activation strength and 5 means normal strength against resistance	Baseline (week 0), pre intervention (week 1) and post intervention (week 6).
Secondary	Change from flexibility measured with the Wells y Dillon scale	Flexibility is measured with this scale with the patient sitting and reaching the feet. It is measured in centimeter and a more positive value means a better record.	Baseline (week 0), pre intervention (week 1) and post intervention (week 6).