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Acupuncture vs. Core Stability Training in Women With Fibromyalgia

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03638518
Enrollment
160
Registered
2018-08-20
Start date
2014-01-07
Completion date
2015-04-30
Last updated
2021-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibromyalgia

Keywords

rehabilitation, balance, functional capacity, quality of life, pain, acupuncture

Brief 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.

Detailed 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).

Interventions

OTHERAcupuncture

Acupuncture 5 weeks treatment. 2 sessions a week (30 minutes each session)

OTHERPhysiotherapy

Core stability exercises programme. 2 sessions a week (30 minutes each session) during 5 weeks

Sponsors

University of Extremadura
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

Neither the participants nor their therapists were blind to the treatment allocation. However, the assessor was independent to the study and was not aware of the treatments applied or the objective of the therapy.

Intervention model description

Participants were randomized to a core stability training physiotherapy programme group, an acupuncture treatment group and control group for a 13 week study.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 71 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change from physical function item of the Spanish Fibromyalgia Impact Questionnaire at 5 weeks and 13 weeksBefore treatment, after 5 weeks of treatment and after 6 weeks of follow upThe physical function item of the Spanish Fibromyalgia Impact Questionnaire measures functional capacity with a score of 0 to 3.
Change from the monopodal stance test at 5 weeks and 13 weeksBefore treatment, after 5 weeks of treatment and after 6 weeks of follow upStatic 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.
Change from Berg Balance Scale at 5 weeks and 13 weeksBefore treatment, after 5 weeks of treatment and after 6 weeks of follow upDynamic 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.
Change from Time Up and Go test at 5 weeks and 13 weeksBefore treatment, after 5 weeks of treatment and after 6 weeks of follow upTime up and Go test measures dynamic balance showed in seconds
Change from 10 meter walk test at 5 weeks and 13 weeksBefore treatment, after 5 weeks of treatment and after 6 weeks of follow up10 meter walk test measures walking speed and performance which is related to dynamic balance. The unit use is meter/second.
Change from Health Assessement Questionnaire at 5 weeks and 13 weeksBefore treatment, after 5 weeks of treatment and after 6 weeks of follow upHealth Assessement questionnaire measures the functional capacity of a subject. It provides an impairment score of 0 to 3.
Change from the centre of gravity at 5 weeks and 13 weeksBefore treatment, after 5 weeks of treatment and after 6 weeks of follow upStatic 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

Secondary

MeasureTime frameDescription
Change from pain intensity levels measured with the visual analogue scale at 5 weeks and 13 weeksBefore treatment, after 5 weeks of treatment and after 6 weeks of follow upThe visual analogue scale is a 100-mm scale, where 0 indicated 'no symptoms' and 100 indicating 'extreme and unbearable symptoms'.
Change from joint stiffness levels measured with the visual analogue scale at 5 weeks and 13 weeksBefore treatment, after 5 weeks of treatment and after 6 weeks of follow upThe visual analogue scale is a 100-mm scale, where 0 indicated 'no symptoms' and 100 indicating 'extreme and unbearable symptoms'.
Change from depression level measured with the visual analogue scale at 5 weeks and 13 weeksBefore treatment, after 5 weeks of treatment and after 6 weeks of follow upThe visual analogue scale is a 100-mm scale, where 0 indicated 'no symptoms' and 100 indicating 'extreme and unbearable symptoms'.
Change from perceived difficulty to work measured with the visual analogue scale at 5 weeks and 13 weeksBefore treatment, after 5 weeks of treatment and after 6 weeks of follow upThe visual analogue scale is a 100-mm scale, where 0 indicated 'no difficulty' and 100 indicating 'extreme and unbearable difficulty'.
Change from the Spanish Fibromyalgia Impact Questionnaire at 5 weeks and 13 weeksBefore treatment, after 5 weeks of treatment and after 6 weeks of follow upThe 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026