Acupuncture vs. Core Stability Training in Women With Fibromyalgia

Fibromyalgia Clinical Trial

Official title:

Effectiveness of Acupuncture vs. Core Stability Based Physiotherapy in Balance and Functional Capacity of Women With Fibromyalgia: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03638518
• Other study ID #: 79/2013
• Status: Completed
• Phase: N/A
• Start date: January 7, 2014
• Est. completion date: April 30, 2015

Study information

• Verified date: April 2021
• Source: University of Extremadura
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study analyse the effectiveness of a core stability training Physiotherapy programme versus Acupuncture treatment for the management of balance and functional capacity impairments of women with Fibromyalgia.

Description:

Objective: This study investigated the effectiveness of a core stability training Physiotherapy programme versus Acupuncture for the management of balance and functional capacity impairments of women with Fibromyalgia. Design: A single-blind randomized clinical controlled trial. Setting: University of Extremadura and Olivenza Fibromyalgia Association, Spain Subjects: Women with Fibromyalgia and balance impairment. Interventions: 135 Participants were randomized to a core stability training physiotherapy programme group (n=45), an acupuncture treatment group (n=45) and control group (n=45) for 13 weeks. Main Measures: Measures were taken at baseline (week 0), post intervention (week 6) and at follow up (week 13). The primary outcome measures were static balance (posturography) and dynamic balance and functional mobility (Berg Balance Test, Time Up and Go test and 10-metre walk) and functional capacity (Fibromyalgia Health Assessment Questionnaire (FHAQ) and the physical function item from the Spanish Fibromyalgia Impact Questionnaire (SFIQ)).The secondary outcome measure were quality of life (Spanish- Fibromyalgia Impact Questionnaire), pain, joint stiffness, difficulty to work and depression (measured with the visual analogue scale).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: April 30, 2015
• Est. primary completion date: April 30, 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 71 Years

Eligibility

Inclusion Criteria:

• women between 18 and 71 years old,
• diagnosed with Fibromialgia by a specialized physician,
• having subjective sensation of balance impairments.

Exclusion Criteria:

• The exclusion criteria were to present any medical contraindication for acupuncture and/or physiotherapy, phobia of needles, adverse reactions to medication that could influence in balance, associated pathologies such as alcoholism or severe visual deficit, to have receive acupuncture or core stability based physiotherapy in the two months previous to the intervention and to do physical exercises that train core stability such as Pilates or Yoga

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Other:
• Acupuncture
Acupuncture 5 weeks treatment. 2 sessions a week (30 minutes each session)
• Physiotherapy
Core stability exercises programme. 2 sessions a week (30 minutes each session) during 5 weeks

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 centre of gravity at 5 weeks and 13 weeks	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	Before treatment, after 5 weeks of treatment and after 6 weeks of follow up
Primary	Change from the monopodal stance test at 5 weeks and 13 weeks	Static balance and postural control is the ability to maintain the centre of gravity within the base of support. Monopodal stance test measures static balance in percentage through posturography study.	Before treatment, after 5 weeks of treatment and after 6 weeks of follow up
Primary	Change from Berg Balance Scale at 5 weeks and 13 weeks	Dynamic balance is the ability to maintain the centre of gravity within the base of support during the performance of functional activities. Berg Balance scale measures dynamic balance through performing multiple tasks and with a score of 0 to 56.	Before treatment, after 5 weeks of treatment and after 6 weeks of follow up
Primary	Change from Time Up and Go test at 5 weeks and 13 weeks	Time up and Go test measures dynamic balance showed in seconds	Before treatment, after 5 weeks of treatment and after 6 weeks of follow up
Primary	Change from 10 meter walk test at 5 weeks and 13 weeks	10 meter walk test measures walking speed and performance which is related to dynamic balance. The unit use is meter/second.	Before treatment, after 5 weeks of treatment and after 6 weeks of follow up
Primary	Change from Health Assessement Questionnaire at 5 weeks and 13 weeks	Health Assessement questionnaire measures the functional capacity of a subject. It provides an impairment score of 0 to 3.	Before treatment, after 5 weeks of treatment and after 6 weeks of follow up
Primary	Change from physical function item of the Spanish Fibromyalgia Impact Questionnaire at 5 weeks and 13 weeks	The physical function item of the Spanish Fibromyalgia Impact Questionnaire measures functional capacity with a score of 0 to 3.	Before treatment, after 5 weeks of treatment and after 6 weeks of follow up
Secondary	Change from the Spanish Fibromyalgia Impact Questionnaire at 5 weeks and 13 weeks	The Spanish Fibromyalgia Impact Questionnaire measures the quality of life and the impact of Fibromyalgia on the life of persons diagnosed with this condition. The maximum score is 100 and the higher the result obtained, the higher the impact of the condition on the person and the less quality of life he/she has.	Before treatment, after 5 weeks of treatment and after 6 weeks of follow up
Secondary	Change from pain intensity levels measured with the visual analogue scale at 5 weeks and 13 weeks	The visual analogue scale is a 100-mm scale, where 0 indicated 'no symptoms' and 100 indicating 'extreme and unbearable symptoms'.	Before treatment, after 5 weeks of treatment and after 6 weeks of follow up
Secondary	Change from joint stiffness levels measured with the visual analogue scale at 5 weeks and 13 weeks	The visual analogue scale is a 100-mm scale, where 0 indicated 'no symptoms' and 100 indicating 'extreme and unbearable symptoms'.	Before treatment, after 5 weeks of treatment and after 6 weeks of follow up
Secondary	Change from depression level measured with the visual analogue scale at 5 weeks and 13 weeks	The visual analogue scale is a 100-mm scale, where 0 indicated 'no symptoms' and 100 indicating 'extreme and unbearable symptoms'.	Before treatment, after 5 weeks of treatment and after 6 weeks of follow up
Secondary	Change from perceived difficulty to work measured with the visual analogue scale at 5 weeks and 13 weeks	The visual analogue scale is a 100-mm scale, where 0 indicated 'no difficulty' and 100 indicating 'extreme and unbearable difficulty'.	Before treatment, after 5 weeks of treatment and after 6 weeks of follow up