Acupuncture vs. Core Stability Training in Women With Fibromyalgia
- Conditions
- Fibromyalgia
- Registration Number
- NCT03638518
- Lead Sponsor
- University of Extremadura
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 160
- women between 18 and 71 years old,
- diagnosed with Fibromialgia by a specialized physician,
- having subjective sensation of balance impairments.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change from Berg Balance Scale at 5 weeks and 13 weeks Before treatment, after 5 weeks of treatment and after 6 weeks of follow up 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.
Change from 10 meter walk test at 5 weeks and 13 weeks Before treatment, after 5 weeks of treatment and after 6 weeks of follow up 10 meter walk test measures walking speed and performance which is related to dynamic balance. The unit use is meter/second.
Change from the monopodal stance test at 5 weeks and 13 weeks Before treatment, after 5 weeks of treatment and after 6 weeks of follow up 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.
Change from the centre of gravity at 5 weeks and 13 weeks Before treatment, after 5 weeks of treatment and after 6 weeks of follow up 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
Change from Time Up and Go test at 5 weeks and 13 weeks Before treatment, after 5 weeks of treatment and after 6 weeks of follow up Time up and Go test measures dynamic balance showed in seconds
Change from Health Assessement Questionnaire at 5 weeks and 13 weeks Before treatment, after 5 weeks of treatment and after 6 weeks of follow up Health Assessement questionnaire measures the functional capacity of a subject. It provides an impairment score of 0 to 3.
Change from physical function item of the Spanish Fibromyalgia Impact Questionnaire at 5 weeks and 13 weeks Before treatment, after 5 weeks of treatment and after 6 weeks of follow up The physical function item of the Spanish Fibromyalgia Impact Questionnaire measures functional capacity with a score of 0 to 3.
- Secondary Outcome Measures
Name Time Method Change from joint stiffness levels measured with the visual analogue scale at 5 weeks and 13 weeks Before treatment, after 5 weeks of treatment and after 6 weeks of follow up The 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 weeks Before treatment, after 5 weeks of treatment and after 6 weeks of follow up The 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 weeks Before treatment, after 5 weeks of treatment and after 6 weeks of follow up 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.
Change from pain intensity levels measured with the visual analogue scale at 5 weeks and 13 weeks Before treatment, after 5 weeks of treatment and after 6 weeks of follow up The 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 weeks Before treatment, after 5 weeks of treatment and after 6 weeks of follow up The visual analogue scale is a 100-mm scale, where 0 indicated 'no symptoms' and 100 indicating 'extreme and unbearable symptoms'.