Clinical trial NCT03638518: Acupuncture vs. Core Stability Training in Women With Fibromyalgia
Official title: Effectiveness of Acupuncture vs. Core Stability Based Physiotherapy in Balance and Functional Capacity of Women With Fibromyalgia: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: rehabilitation
balance
functional capacity
quality of life
pain
acupuncture
Lead sponsor: University of Extremadura
Sponsor class: OTHER
First posted: 2018-08-20
Enrollment: 160
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 71
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Change from the centre of gravity at 5 weeks and 13 weeks
timeFrame: Before treatment, after 5 weeks of treatment and after 6 weeks of follow up
measure: Change from the monopodal stance test at 5 weeks and 13 weeks
timeFrame: Before treatment, after 5 weeks of treatment and after 6 weeks of follow up
measure: Change from Berg Balance Scale at 5 weeks and 13 weeks
timeFrame: Before treatment, after 5 weeks of treatment and after 6 weeks of follow up
measure: Change from Time Up and Go test at 5 weeks and 13 weeks
timeFrame: Before treatment, after 5 weeks of treatment and after 6 weeks of follow up
measure: Change from 10 meter walk test at 5 weeks and 13 weeks
timeFrame: Before treatment, after 5 weeks of treatment and after 6 weeks of follow up
measure: Change from Health Assessement Questionnaire at 5 weeks and 13 weeks
timeFrame: Before treatment, after 5 weeks of treatment and after 6 weeks of follow up
measure: Change from physical function item of the Spanish Fibromyalgia Impact Questionnaire at 5 weeks and 13 weeks
timeFrame: Before treatment, after 5 weeks of treatment and after 6 weeks of follow up
Secondary outcomes:
measure: Change from the Spanish Fibromyalgia Impact Questionnaire at 5 weeks and 13 weeks
timeFrame: Before treatment, after 5 weeks of treatment and after 6 weeks of follow up
measure: Change from pain intensity levels measured with the visual analogue scale at 5 weeks and 13 weeks
timeFrame: Before treatment, after 5 weeks of treatment and after 6 weeks of follow up
measure: Change from joint stiffness levels measured with the visual analogue scale at 5 weeks and 13 weeks
timeFrame: Before treatment, after 5 weeks of treatment and after 6 weeks of follow up
measure: Change from depression level measured with the visual analogue scale at 5 weeks and 13 weeks
timeFrame: Before treatment, after 5 weeks of treatment and after 6 weeks of follow up
measure: Change from perceived difficulty to work measured with the visual analogue scale at 5 weeks and 13 weeks
timeFrame: Before treatment, after 5 weeks of treatment and after 6 weeks of follow up
Other outcomes:
Locations:
Study officials:
affiliation: University of Extremadura
name: Elisa Mª Garrido Ardila, Professor
role: PRINCIPAL_INVESTIGATOR
References: